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Job DescriptionSalary: $165,000-$185,000 Mamas Creations, Inc. (NASDAQ: MAMA) is a leading marketer and manufacturer of fresh deli prepared foods, found in over 8,500 grocery, mass, club and convenience stores nationally. The Companys broad product portfolio, born as MamaMancinis, from a rich history in Italian foods, now consists of a variety of high quality, fresh, clean and easy to prepare foods to address the needs of both our consumers and retailers. Our vision is to become a one-stop-shop deli solutions platform, leveraging vertical integration and a diverse family of brands to offer a wide array of prepared foods to meet the changing demands of the modern consumer. For more information, please visit . We have an excellent opportunity for a highly skilled and experienced leader to serve as the Senior Director, Plant Operations of our East Rutherford facility. You will be the senior site leader responsible for the overall performance, safety, Grandma Quality, controls, culture, and financial results of the manufacturing facility. This role serves as the plants general manager, accountable for translating enterprise strategy into consistent, disciplined execution with excellence at the site level. The Senior Director leads through people, systems, and standards, ensuring production, FSQA, maintenance, warehousing, and workforce leadership operate in alignment with Grandma Quality. This role balances results with responsibility, honoring Mamas heritage while building scalable, sustainable operations. Key Responsibilities • Own end-to-end plant performance, including safety, food safety, quality, service, cost, labor efficiency, and employee engagement., • Own overall plant efficiency and throughput performance, ensuring production capacity, labor models, and operating practices support enterprise targets., • Drive improvement in throughput, yield, and line performance by setting expectations, removing barriers, and holding leaders accountable for results., • Serve as the strategic leader for the site, translating enterprise priorities into clear site-level strategies, initiatives, and execution plans., • Partner with the Senior Manager, Production Operations to ensure production schedules and execution plans support optimal efficiency and service outcomes., • Own the plant operating budget, including labor, overtime, supplies, and controllable costs; ensure performance aligns with financial targets., • Balance cost discipline with Mamas commitment to Grandma Quality, safety, and employee well-being., • Use KPIs and financial data to evaluate performance, prioritize investments, and guide decision-making., • Partner with OpEx/CI to identify and sponsor continuous improvement initiatives that deliver measurable, sustainable gains in efficiency, throughput, and cost performance., • Ensure efficiency gains and cost improvements are sustainable and embedded into standard work and leadership routines., • Lead, coach, and hold accountable all direct reports, site functional leaders, and the downline., • Serve as the primary owner of plant culture, reinforcing values-based leadership, respectful supervision, and consistent accountability., • Ensure site execution aligns with enterprise standards of excellence and Grandma Quality while addressing location-specific risks and opportunities., • Partner with FSQA leadership to maintain strong food safety culture, regulatory compliance, and audit readiness., • Own site-level labor strategy, workforce planning, and performance management in partnership with People Operations., • Drive operational discipline through KPIs, operating practices, and structured problem-solving., • Partner with Reliability & Asset Management to support uptime, preventive maintenance execution, and capital improvements., • Support capital projects, expansions, and equipment installations at the site level., • Participate in operational diligence and integration activities related to acquisitions or expansions impacting the facility., • Serve as the primary escalation point for site risks, performance gaps, and employee relations matters., • Build strong cross-functional relationships that nurture trust, accountability, and pride in workmanship., • Collaborate closely with Senior Directors and plant leaders at other facilities to share best practices, standardize where appropriate, and drive enterprise-wide operational improvement., • Participate in cross-facility working groups, initiatives, and problem-solving efforts to strengthen consistency, performance, and scalability across the enterprise., • Champion collaboration between facilities while respecting site-specific strengths, constraints, and heritage., • Other related tasks, as necessary to drive results and support the business. Qualifications • Bachelors degree in Operations Management, Engineering, Business, or related field; or equivalent experience., • 15+ years of progressive leadership experience in manufacturing operations, preferably in food manufacturing or regulated environments., • 10+ years of experience leading multi-shift operations and managing leaders (managers/supervisors)., • Demonstrated experience owning site KPIs, budgets, labor planning, and operational performance improvement., • Expert usage of ERP systems. NetSuite preferred., • Strong working knowledge of food safety/regulatory environments (USDA/FDA), HACCP, GMPs, and audit readiness expectations., • Proven ability to lead through change while maintaining operational stability and culture., • Strong communication, planning, and cross-functional leadership skills., • Lean/Six Sigma knowledge/certification, preferred., • Bilingual (English/Spanish) highly preferred. Essential Physical Requirements • Ability to regularly walk, stand, and move throughout the manufacturing facility., • Ability to navigate stairs, catwalks, and uneven surfaces safely., • Ability to visually and audibly observe operations and employee practices., • Ability to wear required PPE (hair/beard nets, safety shoes, gloves, safety glasses, hearing protection)., • Ability to work in varying environmental conditions (heat, cold, noise, humidity)., • Ability to sit for extended periods while performing administrative work., • Ability to travel locally as required., • Ability to communicate clearly and effectively. We offer a comprehensive compensation package that includes a base salary (to $185k,) plus bonus eligibility, paid time off, holiday pay, medical, dental, vision, and life insurances, FSA, EAP, and 401(k.)

Job DescriptionSUMAMRYThe Packer is responsible for accuracy of bag weights, sealing and labeling of bags, coding of bags, checking to be sure the correct bags are being packed, and ensuring volume of output. They are also responsible for keeping the work area neat and clean. Packers may be assigned other duties as needed by the Manager/Supervisor.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Operate the pack line in an efficient manner to meet operating targets for efficiency, downtime, and minimal rework, • Repair pallets of finished product as they occur (broken bags, missing labels etc.), • Operate Forklift, • Pull pallets of flour from packing line and place them accurately in designated storage areas with proper scanning using Scanwork, • Operate tote packer; fill totes with farina, whole wheat, flour, etc., • Understand and use Scanworx inventory system in regards to warehouse packing supplies and finished product movements, • Understand policies and procedures set forth by BSM, USDA & other applicable food production entitiesQUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • Must have operational knowledge of packing equipment, including a Packer, Check-Weigher, Stacker/Bundler, Palletizer, and Stretch Hooder, • Must be capable of trouble-shooting common issues and communicating problems to maintenance/management, • Must be Forklift Certified, • Must be able to communicate in English, both verbal and written, • Must be able to perform basic math functions, with or without the aid of a calculator, • Must be capable of learning computer entry, • Must be an independent worker with self-initiative to carry out job functions, • Must be willing to rotate shifts and cover absences if requiredPHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • Must be able to work in an environment, which has extremes in temperature, • Must be able to climb ladders, • Must have physical dexterity to perform basic repair functions, • Must be able to stand for extended periods of time, • Must be able to bend, stoop, kneel, crouch, twist and crawl frequently, • Must be able to frequently lift and/or move 50 pound bags, • Vision requirements are close vision, distance vision, color vision and depth perceptionWORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly exposed to moving mechanical parts, and fumes or airborne particles. The employee is exposed to vibrations. The employee is occasionally exposed to high precarious places. The employee will be exposed to extremes in temperature, both hot and cold. The work environment is noisy, at times in excess of 100 decibels.FOOD SAFETY / SECURITY AND QUALITY REQUIREMENTSThe Company is committed to producing and delivering defect free products that are in compliance with all applicable legal and regulatory requirements and are of the highest levels of food safety, quality and productivity. To ensure this, all employees are required to be trained on and adhere to the FDA Current Good Manufacturing Policies as set forth by the Company as they pertain to personnel practices, equipment and facilities. It is also vital that all employees be aware of their work environment and prevent any accidental or intentional adulteration of the products produced at the facility.FULL-TIME/PART-TIME: Full timeSALARY: $25.49AVAILABILITY: Open AvailabilityPOSITION: Packing OperatorNUMBER OF OPENINGS: 2LOCATION” Strike Force Staffing- Clifton, NJ

Job Description Welcome! Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions and symptoms caused by excess neural excitability. Ovid is advancing a pipeline of novel targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. It is with curiosity, courage, and tenacity that, together, we work for meaningful change in the lives of patients and their families. With this sense of purpose and urgency we challenge the conventional and embrace the wisdom and thought that comes from diverse backgrounds and perspectives. Importantly, we understand the commitment we make to our patients, our broad community and to each other is based on the humanity that we share. The Role On Our Team We are seeking an experienced Clinical Operations professional in New York City, Philadelphia, or Boston area for our trials spanning early to late-stage clinical development. Your role will be responsible for overseeing and managing all aspects of clinical operations for a high priority program. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders working cross functionally with Clinical Development, Regulatory, Non Clinical and other internal functions to develop operationally feasible and clear protocol concepts and final protocols, and will independently oversee one or more clinical studies by establishing the operational strategy and securing excellence in execution through external partners to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III). This role will be a leader in the organization who knows how to manage a team internally, at our clinical sites and with our vendors. Reporting to the Sr Vice President, this is a highly visible and team-facing role. The role is a hybrid of office visits in NYC, working from home, and traveling to our sites and for business meetings. Key Responsibilities and Impact • Manage interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders and effectively interact with scientists and managers within and outside Clinical Research Organization (CRO), vendors, and partners. Have strong outsourcing experience, • Provide program-level sponsor’s operational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget, • Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors, • May also be responsible for contributing to a clinical development plan within a program moving into a new or subdivision of a current indication, • Organize and lead study specific meetings, • Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, robust, data monitoring plans, and other study documents, • Develop operational strategy along with CRO/vendors aligned with the program strategy and incorporating local and country-level input, • Lead and oversee the strategic planning, implementation and execution of clinical trials across key programs in accordance with project timelines, budget, and quality standards, • Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies, • Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones, • Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program, • Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards, • Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct, • Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity, • 10+ years of clinical research / project management experience preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline, and budget expectations., • Detailed understanding and experience in all aspects of clinical protocol development, implementation, regulatory submissions, and overall drug development, • Ability to establish operational plans and support the CRO/vendor in the execution of the plans., • Prior investigator site and/or monitoring experience is advantageous, • Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the development of study designs is desirable., • Adaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and multi-task so to thrive in a small company, fast-paced environment, • Marked proficiency in clinical and/or medical writing, • Broad experience in early-stage and late-stage development programs, • Demonstrated experience working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, • Extensive knowledge of regulatory guidelines and experience with worldwide regulatory agencies in therapeutic product development; global experience highly preferred, • Outstanding presentation, written and oral skills are required. A clear communicator who can influence effectively both internally and externally, • Bring a history of great collaboration and teamwork with the ability to motivate and influence others; have a reputation for successful partnering with internal and external stakeholders, • Have the ability and the drive to succeed in a small biotech organization. Interest to grow in the function to advance new technologies in new therapies. Must be self-motivated, proactive, work well under pressure and deadlines, and thrive in a small “all hands-on deck” environment, • Solution-oriented thinker who possesses a “can do” attitude with a strong sense of urgency, • Create a balance of analytical and methodical problem solving with creative and flexible solutions Ovid operates in a hybrid-work model. Candidates applying must be willing and able to be in the NYC office in coordination with their manager's expectations, as well as department and business needs. The base salary range for this position is $200,00-270,000. The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, skills, level offered, and performance expectations. Powered by JazzHR lJ9lJ1vhhf

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix is looking for a full-time Senior Director of Program and Portfolio Management (PPM) to effectively shape and implement PPM strategies decision making for a complex portfolio of drug development programs and execution of decisions. The Senior Director of PPM will be a responsible for implementing portfolio management best practices, drafting strategic and operational plans, mentoring project managers (PM) and operational staff, and supporting effective communications across multiple departments at Tonix. The individual in this position will also be responsible for building out the team of PMs which would report into this role. This is a fast-paced, challenging position offering a competitive compensation and benefits package. This position will report directly to the Company’s Chief Operating Officer that will ideally be based at the Tonix Chatham, NJ office. Essential Duties • Lead and manage cross-functional teams interacting with clinical, nonclinical, regulatory, CMC, discovery, and others to set priorities, work toward goals and monitor progress of programs, • Develop portfolio tools and materials to support portfolio decision-making, • Create, implement, and refine PPM practices to support leadership, PPM staff, and delivery of program goals, • Lead regular portfolio operations committee meetings and portfolio strategy sessions, • Coordinate and manage due diligence teams and decision making on in licensing activities for the portfolio, • Help to buildout and lead PMs responsible for developing cross-functional program plans, timelines, and budgets in collaboration with functional area leads, • Facilitate effective, science-based business decisions including development of scenarios and strategic impact of decisions, • Ensure all decisions are assessed as to their risks and impacts as well as accountable for communication to team and stakeholders in a transparent and timely manner, • Function as an integrator within the project team and across the Company to ensure alignment, • Develop and coordinate resource and budget planning activities across functions to ensure adequate resources are applied to the programs and decisions are assessed for portfolio impact, • Provide leadership to teams and functional areas to proactively anticipate and identify project issues which pose a challenge to achieving strategic goals; propose and implement plans to resolve such issues, and execute corrective actions, • Effectively execute change management to implement strategies for effecting, controlling, and helping teams adapt to change, • Provide updated project information for the Board as well as for regular budget and portfolio reviews, • Enable high-performing teams by ensuring good team dynamics within the project team, • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s), • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork, • Recruits, interviews, hires, and trains new team members, • Oversees the daily workflow of the department, • Provides constructive and timely performance evaluations, • If necessary, handles discipline and termination of employees in accordance with company policy, • Bachelor’s degree and fifteen (15) years of relevant project / program / portfolio management experience within the pharmaceutical / biotechnology industry; or a PhD in a scientific field or a PharmD, DVM or MD degree with ten (10) years of relevant experience preferred, • Scientific background and/or MBA preferred, • Ten (10) years of leading cross-functional program or portfolio management activities within the pharmaceutical industry with a deep understanding of practices and standards of pharmaceutical program and portfolio management preferred, • Experience managing PM professionals in the drug development industry, • Strong leadership presence with the ability to translate strategy into action, • Excellent analytical skills with an ability to summarize and present complex information in a clear and concise manner to support decision-making, • Ability to create an inclusive environment and lead empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration, • Outstanding verbal and written communications skills with the ability to effectively interact with and influence all levels within the company, • Ability for minimal travel, • Dedicated team player who is able to withstand the high demands of a fast-paced environment Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $200,000 to $300,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management:, • Documentation control (master batch record, specification and method), • Batch record review and product disposition, • Investigations, complaints, deviations, CAPAs, APRs, • Production and Pharmaceutical Development support, • APRs, GMP training and SOP review, • Validation / qualification documentation review and approval, • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site, • Develop, maintain, and enhance training programs and systems, • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives., • Must be able to move about the facility, • Experience with FDA Audit, • Extensive knowledge of US and EU current Good Manufacturing Practices, • Experience with a CDMO would be preferable, • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals Company DescriptionWe are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..

Job Description Customs Brokerage Manager (Remote) Preferred: New York area (remote candidates welcome) Full-Time | Salary: $85,000–$100,000/year Join a well-established international logistics firm seeking a seasoned Customs Brokerage Department Managerto lead and manage a high-performing team of four. This is a fully remote position, ideal for a candidate with strong leadership experience in customs brokerage and hands-on entry processing. Key Responsibilities: • Oversee daily operations of the Customs Brokerage Department, ensuring compliance and efficiency, • Lead a team of four (including licensed brokers), with one upcoming retirement creating a key leadership gap, • Manage and process customs entries (approx. 325–350 entries/month), • Monitor and interpret tariff changes, customs regulations, and trade compliance updates, • Keep the department fully informed and trained on regulatory changes, • Work directly in CargoWise to manage processes and data, • Maintain departmental performance metrics and drive continuous improvement Qualifications:, • Required: Prior experience managing a customs brokerage department, • Preferred: Licensed U.S. Customs Broker, • Proficient in CargoWise software (required), • Strong knowledge of U.S. Customs regulations and HTS classification, • Willingness to be both a hands-on contributor and strategic team leader, • Excellent communication, compliance, and leadership skills Requirements Qualifications • 5–10 years of experience in customs brokerage or import operations within the freight forwarding industry, • CargoWise experience is required, • Strong knowledge of HTS classification, CBP regulations, and PGA requirements, • Experience with FDA codes, Lacey Act entries, and DDP procedures, • Excellent communication, problem-solving, and organizational skills, • Salary: $85,000 – $100,000 based on experience, • Vacation: 10 business days annually, • 401(k): 3% company contribution (eligible after 1 year, with enrollment windows on Jan 1 and July 1), • Health Insurance: Offered after 2 months of employment

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-O-Vator available for use., • Small breakroom available. No on-site cafeteria available.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Location: Miami (Onsite) Job Description: This role is based at our largest site, Clinical Pharmacology of Miami (CPMI). The Director’s primary role is for ensuring that day-to-day clinical trial operations at the CPMI site are conducted in compliance with study protocols, FDA regulations, and ICH/GCP guidelines. This role provides oversight and reporting to Operational Leadership to maintain the integrity and quality of all site activities. This is a leadership role, and the ideal candidate will have experience mentoring and leading others. Oversight and communication with the Operational Team may include (but is not limited to): • Conducting internal audits, • Monitoring training completion and associated metrics, • Providing support and consultation for Quality events and CAPAs, • Overseeing and assisting with internal and external audits, • Managing and supervising Quality Control plans and QC staff As needed, or in the absence of the Vice President of Quality Assurance, this role may assume leadership of the ERG Corporate QA Team, oversee the planning, execution, and analysis of Quality Assurance initiatives, as well as managing external audits for the organization. This position reports directly to the Vice President of QA. In fulfilling these responsibilities, the CPMI-based Quality Assurance and Compliance Director operates in alignment with FDA regulations, Good Clinical Practice (GCP) guidelines, and the company’s standard operating procedures and policies. Responsibilities: Quality Management of the Clinic • Lead and conduct audits of study documents, Case Report Forms, Clinical Study Reports, and other supporting documentation to ensure compliance, • Collaborate with Site Director and study PIs to resolve and document issues promptly and effectively, • Conduct GCP compliance audits of vendors in accordance with Standard Operating Procedures, • Report significant Quality issues to Vice President, Quality Assurance, • Oversee the implementation of corrective actions with support of the Site Director and VP of Quality, • Responsible for facilitating Sponsor Audits and assisting with other Sponsor site visits as applicable (and to report results of audits to Vice President, QA), • Assist with supporting Regulatory (FDA, EMA, etc) Inspections and preparation activities, • Oversee training is conducted in accordance with SOPs and reports metrics to Operational Leadership for required management and next steps., • Responsible to oversee all Document Control activities for the site, and for other sites as requested from the VP of QA., • Ensure the appropriateness and effectiveness of site CAPA investigations and oversee timely and accurate reporting of results to applicable stakeholders, including Sponsors, CROs, and IRBs., • Responsible to fully manage all aspects of the electronic Quality Management System as it applies to CPMI (and to ERG as a whole under the direction of the VP of Quality)., • Play a key role in site leadership and client engagement, ensuring clear communication, professionalism, and alignment with Operational Leadership and the Quality Assurance Department., • Member of a professional team focused on clinical quality assurance/quality control and compliance-related activities in support of clinical programs and activities., • Assist in maintaining ERGs Quality Management System (QMS), inclusive of the eQMS, to ensure compliance to Good Clinical Practice (GCP) and that the QMS is aligned with the internal policies and standard operating procedures for ERG., • Assist in audit activities in the areas of Vendor Audit Management, facilitation of internal & external clinical quality audits, and agency inspections, • Participate in the oversight of Corrective and Preventive Actions (CAPA) implementation and assist in conducting Quality reviews., • Perform any other tasks/duties assigned by VP QA, • Education and experience, • Thorough understanding of Good Clinical Practices (GCP), Code of Federal Regulations (CFR), and HIPAA as they apply to clinical research., • Bachelor’s degree or higher in life sciences, medicine, or a related field (or equivalent experience)., • Bilingual Spanish highly preferred, • Minimum of 10 years in the pharmaceutical, clinical, or medical device industry, including conducting internal and external audits., • At least 5 years of experience participating in FDA or other regulatory agency inspections (preferred)., • Extensive experience managing CAPA programs with a focus on GCP compliance, ensuring timely completion and deliverables., • Background in project management, site leadership, or oversight of high-volume clinical trials strongly desired., • Experience with 21 CFR Part 11 and aspects of Computer System Validation (preferred but not required)., • Requirements, • Strong understanding of FDA regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines., • Knowledge of medical terminology., • Excellent organizational and prioritization skills with the ability to adapt in a dynamic, changing environment., • Strong analytical and problem-solving abilities., • Ability to provide accurate guidance and support on regulatory requirements., • Excellent documentation practices and attention to detail., • Ability to travel as requested by the Vice President of QA., • Exceptional communication skills (interpersonal, written, and verbal)., • Proficiency in computer applications, including Microsoft Word and Excel, and familiarity with clinical research systems (e.g., Clinical Trial Management Systems).

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job Overview: We are looking for our first Technical Subject Matter Expert in Drug Product to join our team and contribute to our innovative projects and commercial production. You'll provide strategic technical input, manage manufacturing partnerships, contribute to CMC regulatory submissions, and drive product/process improvements. If you're an experienced pharmaceutical professional eager to drive innovation in drug development and ensure robust compliance, this role offers a compelling challenge. Location: Hybrid in our New York City office or Remote in the United States. Reports to: Technical Director, Manufacturing and Supply. Roles and responsibilities (Include but are not limited to): • Technical Subject Matter Expert for all aspects of Compass' Drug Products (DP) in the US in particular, and also aspects of Compass Drug Substances (DS) where appropriate, • To manage, track, and report progress on DP projects and commercial production programs, and to provide strategic and technical input to these projects/programs, • Ensure effective relationships with Compass' Manufacturing partners (CMOs/CDMOs and key suppliers) as required, meeting business objectives and timelines, • To contribute to the writing of relevant dossier sections for CMC regulatory submissions, and ensure technical compliance with recognised regulations and standards, • Identify opportunities for product and process improvements during development and scale up, • To support the Manufacturing & Supply team in any section-related activities as required and as appropriate, • To support compliance and efficiency related projects, • Identify risks, implement mitigation & controls, monitor & report status Candidate Profile: • Education level, • Minimum of Bachelor's degree in science, or equivalent, • Experience, • Demonstrated relevant experience within the pharmaceutical industry; must have DP experience across a variety of formulations and dosage forms, • Experience working with, or for, contract manufacturing organisations (CMOs/CDMOs), • Experience of contributing to CMC Regulatory content., • Experience in technology transfer, process validation and process monitoring, • Technical experience supporting manufacturing within a Quality Management System, • Ability to prioritise tasks and objectives to ensure business goals are achieved, • Specific skills, • Excellent interpersonal communication and strong Stakeholder management skills, • Knowledge and expertise in formulation of DP and dosage forms, • Project Planning & Risk Management, • Ability to react to changing priorities Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$127,500—$172,500 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Who we are: For over 25 years, Global Relay has set the standard in enterprise information archiving with industry-leading cloud archiving, surveillance, eDiscovery, and analytics solutions. We securely capture and preserve the communications data of the world's most highly regulated firms, giving them greater visibility and control over their information and ensuring compliance with stringent regulations. Though we offer competitive compensation and benefits and all the other perks one would expect from an established company, we are not your typical technology company. Global Relay is a career-building company. A place for big ideas. New challenges. Groundbreaking innovation. It's a place where you can genuinely make an impact – and be recognized for it. We believe great businesses thrive on diversity, inclusion, and the contributions of all employees. To that end, we recruit candidates from different backgrounds and foster a work environment that encourages employees to collaborate and learn from each other, completely free of barriers. Your role: Join Global Relay, a leading provider of compliance software solutions, as we embark on an exciting journey to expand our footprint in the healthcare and life sciences industry. We're seeking a seasoned Senior Account Executive to drive sales growth and establish strong relationships with key decision-makers in this critical sector. Our cutting-edge compliance software solutions are designed to help healthcare organizations and life sciences companies maintain regulatory compliance, ensure data security, and optimize legal and compliance operations. With a strong focus on archiving and surveillance needs, our solutions address the complex challenges of HIPAA, FDA regulations, and other industry-specific requirements. As a Senior Account Executive, you will play a critical role in identifying and addressing the unique needs of these organizations, demonstrating the value of our solutions, and guiding them through the sales process. The ideal candidate will have a proven track record in software sales, specifically in compliance-related solutions, and a strong understanding of the regulatory landscape within healthcare and life sciences. You will work closely with prospects to identify their unique needs, demonstrate the value of our solutions, and guide them through the sales process from initial engagement to closing. Your responsibilities: • Sales & Business Development:, • Prospect, identify, and target new business opportunities in the healthcare and life sciences verticals with a focus on compliance-related archiving and surveillance solutions., • Develop and execute strategic sales plans to meet or exceed annual revenue targets., • Lead the full sales cycle, including prospecting, needs assessment, product demonstrations, proposal development, negotiations, and closing deals., • Consultative Selling & Solution Design:, • Conduct in-depth needs assessments with prospective clients to understand their challenges related to data archiving, eDiscovery, surveillance, and regulatory compliance., • Provide expert consultation on how our software solutions can address their specific compliance requirements, streamline workflows, and mitigate risk., • Build and maintain strong, long-term relationships with key decision-makers at healthcare organizations and life sciences companies., • Industry Knowledge & Regulatory Expertise:, • Stay informed about the latest industry trends, regulations, and compliance standards (e.g., HIPAA, FDA regulations, 21 CFR Part 11, GxP, GDPR, DOJ) affecting the healthcare and life sciences sectors., • Use your knowledge of the healthcare and life sciences industries to clearly articulate the benefits and value of compliance-focused archiving and surveillance solutions., • Collaboration & Reporting:, • Collaborate with cross-functional teams, including marketing, customer success, and revenue operations, to align on sales strategies and customer needs., • Provide regular updates on sales progress, pipeline status, customer feedback, and market trends to management., • 7-10+ years of experience in sales, with a strong focus on compliance software solutions, preferably in the healthcare and life sciences industries., • Experience with archiving, surveillance, or compliance-related software solutions is preferred., • Exceptional consultative selling skills, with the ability to understand complex customer requirements and translate them into tailored software solutions., • Strong understanding of regulatory compliance and guidance in the healthcare and life sciences sectors (e.g., HIPAA, FDA, 21 CFR Part 11, DOJ ECCP)., • Bachelor's degree in Business, Life Sciences, Healthcare Administration, Computer Science, Risk Management, or a related field., • Knowledge of Salesforce, Zoom Info, LinkedIn Sales Navigator, and Demandbase are preferred., • Strong communication, presentation, and negotiation skills., • Ability to build relationships with C-level executives, IT professionals, Legal, and Compliance officers., • Self-starter with a goal-oriented mindset and the ability to thrive in a fast-paced, target-driven environment. Compensation: Global Relay advertises the pay range for this role in compliance with applicable pay transparency laws. Individual pay rates are determined by evaluating factors such as expertise, skills, education, and professional background. The range below reflects the expected annual base salary, which is only one element of our comprehensive total rewards package designed to reflect our company pay philosophy, culture and values. We aim to foster an inspiring work environment and support employees' work-life rhythms. We provide a comprehensive health benefits program, including extended health coverage, and short-term / long-term disability insurance. Employees receive annual allotted vacation days, which increase based on tenure. Other benefits include paid sick days, maternity/parental leave enhanced program, commuter benefits, and a 401(k)-retirement plan with company contribution matching. This role is also eligible for a commission structure. For employees at our New York office, we provide additional perks and amenities to enhance your work experience including a subsidized meal program, courtesy of our in-house culinary team! Base salary$150,000—$200,000 USD What you can expect: At Global Relay, there's no ceiling to what you can achieve. It's the land of opportunity for the energetic, the intelligent, the driven. You'll receive the mentoring, coaching, and support you need to reach your career goals. You'll be part of a culture that breeds creativity and rewards perseverance and hard work. And you'll be working alongside smart, talented individuals from diverse backgrounds, with complementary knowledge and skills. Global Relay is an equal-opportunity employer committed to diversity, equity, and inclusion. We seek to ensure reasonable adjustments, accommodations, and personal time are tailored to meet the unique needs of every individual. To learn more about our business, culture, and community involvement, visit .

Job Description Primary Responsibilities · Lead Clinical Pharmacology strategy across early and late stage development, integrating PK, PD, exposure–response, and biomarker data to inform dose selection, regimen, and overall study design. · Own model informed drug development (MIDD) plans (e.g., population PK, PBPK, and quantitative systems approaches) to optimize trial designs and decision points from first in human through pivotal phases. · Author and review CP deliverables for protocols, clinical development plans, IBs, SAPs, and regulatory documents (IND/IMPD/NDA/BLA/MAA), ensuring clarity, traceability, and compliance. · Drive analysis & reporting of PK/PD and exposure–response results (internal and CRO executed), ensuring scientific integrity, reproducibility, and timely insights for program teams and governance. · Establish bioanalytical strategy and standards (method selection/validation, sample handling, and data QC) in partnership with Translational Medicine and external labs/CROs. · Lead Health Authority interactions for CP topics; prepare briefing materials, address IRs, and represent the function in meetings with FDA, EMA, and other agencies. · Provide cross functional leadership with Clinical, Biostatistics, Data Science, CMC, and Regulatory to integrate quantitative evidence into go/no go decisions and portfolio prioritization. · Vendor selection and management for CP related CROs; define scopes, oversee execution, and ensure deliverables meet quality and timeline commitments. · Advance standards & governance (CDISC/ADaM for PK datasets, data pipelines, analysis reproducibility), championing best practices and inspection readiness for a GxP environment. · People collaborations (please note this is an individual contributor role): Must roll up sleeves and be a doer who wants to be into the details themselves. Mentor staff cross functionally and foster an inclusive, high-performance culture consistent with Immuneering values. Qualifications Education · Education: PhD or PharmD (or MS with significant industry experience) in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related quantitative field required. · Experience: Minimum of 5+ years in biotech/pharma Clinical Pharmacology required, more years of experience is a plus, including end-to-end ownership of CP strategy, MIDD, and regulatory submissions across Phase 1–3. · Technical depth: • Population PK/PD modeling (NONMEM, Monolix), PBPK (Simcyp, GastroPlus), and exposure–response methods., • Bioanalytical method development/validation oversight and data integrity in GxP contexts. Soft skills: Strong experience working as an individual contributor. This is a single employee function expected to collaborate with internal functions for success. Exceptional scientific communication, cross functional influence, vendor management, and decision making in fast paced settings. Must embody Immuneering’s core values of: Data Rules, Humble, All In, Care and Own It (accountability). Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job DescriptionStandards & Practices Associate / Ad Review Specialist New York, NY 10013 $28.00 - $31.00/hour (based on experience) Full-Time | Hybrid (In Office Mon-Thurs, Remote Fridays) Position Overview We are seeking a detail-oriented and analytical Standards & Practices Associate to support the review and compliance of advertising content across multiple platforms. This role is responsible for evaluating advertising materials to ensure accuracy, truthfulness, and adherence to internal policies and industry regulations. This is an excellent opportunity for someone with a strong interest in advertising, media, law, or research who thrives in a fast-paced, high-volume environment and enjoys analytical, detail-driven work. Key Responsibilities Advertising Review & Compliance • Review advertising content at various stages of development to ensure accuracy, truthfulness, and compliance with internal policies and industry regulations, • Identify express and implied claims within advertisements and evaluate supporting documentation, • Assess substantiation materials including clinical studies, market research, product testing data, and statistical analyses, • Ensure advertising aligns with standards related to taste, appropriateness, and current social contextResearch & Analysis, • Conduct in-depth research to support advertising claims and regulatory compliance, • Apply knowledge of FTC, FCC, FDA, and other relevant guidelines to evaluate content, • Identify potential risks and compliance issues with strong attention to detailDocumentation & Record Management, • Maintain accurate and thorough records of all reviews, communications, and supporting documentation, • Manage and organize high volumes of content and historical records for retrieval and audit purposes, • Track decisions and maintain consistency across reviewsCollaboration & Communication, • Partner with internal teams and external stakeholders to provide guidance and feedback on advertising content, • Communicate findings clearly and professionally, both verbally and in writing, • Support a collaborative and solutions-oriented review processBasic Qualifications, • Bachelor's degree (BA/BS) required, • 1 or more years of experience in a role requiring marketing regulations support or advertisement review, • Strong research, critical thinking, and organizational skills, • Excellent written and verbal communication skills, • Ability to manage a high volume of assignments in a fast-paced environment, • Self-starter with the ability to work both independently and collaborativelyPreferred Qualifications, • Familiarity with advertising or marketing laws and regulations (FTC, FCC, FDA), • Background in clinical research, product testing, market research, or statistical analysis, • Experience in advertising standards, broadcast, or media production, • Industry exposure to pharmaceuticals, consumer goods, political advertising, or gaming, • Strong issue-spotting abilities and attention to detailPay Details: $28.00 to $31.00 per hour Search managed by: Riley Grubbs Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance OrdinanceMassachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The R&D Formulation Manager/Principal Scientist will lead the design, development, and implementation of novel formulations and polymer materials for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise in formulation development, building and optimizing internal capabilities to deliver innovative and efficient solutions, and ensuring alignment with the company’s long-term technical vision to create a strong pipeline of customer-focused innovations. Key responsibilities include developing and characterizing formulations, recruiting and onboarding talent, managing technical collaborations with external suppliers and vendors, and integrating formulations into scalable manufacturing processes, whether in-house or through CDMOs. This role operates in a collaborative, cross-functional environment, requiring flexibility, a strong focus on scientific formulation, and a drive to explore new technologies and techniques in pursuit of robust, innovative materials and products. This is a senior technical role overseeing a small team. The R&D Formulation Manager/Principal Scientist is expected to be a subject matter expert in areas including polymer material science, formulation strategies, analytical chemistry, and biomaterial interactions with biological systems. They are responsible for ensuring high standards in research practices. They are responsible for leading the creation of documentation required for regulatory submissions, developing strategies for grants and publications, and securing non-dilutive funding through grant opportunities. They will report to the Vice President Technology. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities • Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products., • Provide sound scientific leadership, monitoring, and coaching through the initiation, planning and execution their team’s overall activities., • Create and lead experimentation for exploratory and/or product development research with focus on polymeric materials and their use., • Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures., • Lead material/design/process changes through design control process, with well-documented research/analyses., • Review and author protocols and reports including development studies and design verification/validation activities., • Develop and implement investigations into new technologies and capabilities, partnering with business development, that advance research team and company objectives., • Lead efforts in chemical and mechanical property evaluation to assess the desirability of process or formulation changes. Develop test method capabilities to support R&D (exploratory research, product development) and production test requirements., • Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage., • Lead and participate in voice-of-customer (VOC) labs and influence go-to-market strategies., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and other assessments., • Ensure an effective documentation system is in place and utilized throughout the development process inclusive of R&D lab notebooks, design reviews, test methods, and test reports., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Act as research liaison between R&D and Quality Control to define product specifications., • Maintain active dialogue with Manufacturing to ensure successful technology transfer and process development, including the review of research-related documents, • Provide guidance and support to commercial teams, support introduction of new technologies with development of presentations, sales tools, formulations and applications data., • Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Master’s degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or a closely equivalent discipline., • A minimum of 10 years of research experience in developing and utilizing polymeric materials, biomaterials, or other complex materials toward product/application development and their manufacture, with at least 5 years in a non-academic setting., • A minimum of 2 years of direct management experience., • Adept experimentalist with hands-on research experience with polymers, coagulation chemistry, and materials science of complex systems, including the development of structure-property performance relationships in designing and characterizing these materials., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements, along with a fundamental understanding of the chemistry that drives the performance required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Direct experience in new product development from concept to regulatory approval through launch., • Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required., • Excellent verbal and written communication skills, with the ability to lead in a dynamic and collaborative environment is required., • Highly organized and detail-oriented, with the ability to extract key facts from complex information and create/present clear and concise technical documentation is required., • Demonstrated ability to lead and inspire teams and develop and mentor individuals, and allocate resources strategically and according to the portfolio priorities., • Requires strong leadership and organizational skills with a strong attention to detail and multi-tasking skills while simultaneously keeping overall “big picture” view of projects, priorities, and strategies., • Experience working under pressure with tight timelines, with the ability to maintain a sense of priorities, focus, urgency, and delivery., • Strong working knowledge of Microsoft Office., • Legal authorization to work in the United States. Preferred Qualifications • Ph.D. in a relevant discipline is strongly preferred., • Experience developing and commercializing products in a highly regulated environment, • Medical device development experience., • Demonstrated expertise in the use, development, and qualificication of material characterization techniques, including rheological, thermal, mechanical, spectroscopic, microscopic, and other chemical compositional methods., • Strong understanding of medical device regulatory requirements for Class II and III medical devices (e.g., 21 CFR Part 820), cGLP/cGMP, and related standards (e.g., ISO 13485)., • Strong understanding of cGMP, ICH guidelines, • Six sigma green belt or black belt certification., • Experience with executing a grant and publication submission strategy, knowledge of and strong track record with SBIR submissions to multiple agencies, including NIH and DOD is strongly preferred., • Demonstrated experience in Project Management and Product Lifecycle Management practices, and the ability to lead multiple projects simultaneously., • Excellent problem-solving skills and a proactive approach to addressing formulation challenges. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits BENEFITS • Competitive annual base salary range of $130,000 - $180,000, depending upon qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job DescriptionCompliance Investigator, Clinical ManufacturingAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investigator, Clinical Manufacturing leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS degree in a Quality/ Process related field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Quality Systems Training (Deviation/CAPA)Working Environment While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description ABOUT ORGANOX: OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. Position Summary The Logistics Specialist is responsible for processing customer orders and returns, coordinating domestic and international shipments, creating shipping documentation, return requests, order acknowledgments, and sales quotations in SAP. This role also supports continuous process improvement initiatives to optimize logistics efficiency, compliance, and customer satisfaction. Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive. This is an on-site position in Madison at least three days per week with an additional fourth day needed from time to time. Major Responsibilities: Under direction from the Operations Manager, the Logistics Specialist will be responsible for: · Process customer orders in a timely and accurate manner to maintain an outstanding service level for all customers. · Maintain positive and professional relationships with all customers, third-party logistics (3PL) providers, and carrier partners. · Coordinate both domestic and international shipments, ensuring full compliance with shipping regulations, Incoterms, and customs documentation requirements. · Serve as a key point of contact for all logistics-related issues, resolving them promptly and efficiently. · Manage the Return Material Authorization (RMA) process for the return of products from customers to OrganOx Inc. (U.S.) and OrganOx Ltd. (U.K.). · Create order acknowledgments, delivery notes, stock transfers, return requests, and sales quotations in SAP. · Collaborate with cross-functional teams and Operations leadership to ensure timely and accurate delivery of products and services. · Monitor logistics workflows and recommend process improvements to enhance efficiency and reduce cost. · Report customer sales, returns, and shipment data on a weekly and monthly basis using SAP and Excel reporting tools. · Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies. Requirements Skills & Experience • Minimum of 3 years of experience in logistics and international shipments, including knowledge of:, • Incoterms and their application in international trade, • Customs clearance procedures and import/export documentation, • Commodity codes / Harmonized Tariff Schedule (HTS) classification, • Import/export regulatory compliance (e.g., FDA, CBP, as applicable), • Previous experience in the medical device or life sciences industry preferred., • Experience with SAP or a similar ERP system., • Strong attention to detail and organizational skills., • Excellent communication skills (written and verbal) for liaising with customers, carriers, and internal teams., • High level of problem-solving and analytical skills., • Proficiency in Microsoft Outlook, Excel, and Word., • Ability to work independently and manage multiple priorities in a fast-paced environment., • Adaptable and proactive in a continuously evolving global logistics landscape. Qualifications • Minimum of 3 years’ experience in a similar logistics or supply chain role, with emphasis on international shipments., • Experience with SAP or equivalent ERP software., • Experience managing the RMA process., • Demonstrated attention to detail and strong organizational capabilities., • Proficient in Microsoft Office Suite (Outlook, Excel, Word). A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate. Benefits We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Job DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes., • Conduct investigation and identify true root cause using appropriate tools., • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates., • Reviews and approves investigations and CAPAs when required;, • Collaborate with cross functional department to develop and track CAPA plans., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Other duties as assigned.REQUIREMENTS, • B.S in biological sciences or other relevant field of study., • Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Competencies/Candidate Profile, • Relevant computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to work in a team-oriented environment., • Must be able to work occasional weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-o-Vator available for use. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionDescription: BASIC FUNCTION: Supervise and participate in the requisition, inspection, preparation, cooking and portioning of food in accordance with the NYC nutrition standards MAJOR DUTIES: · Adhere to Department of Health and OSHA regulations regarding proper kitchen hygiene and maintenance · Develops menu types, structures, contents and cycles. · Develops food specifications for purchase that adheres to dietary prescriptions, FDA (Food and Drug Administration) quality standards and budgetary guidelines. · Prepares and monitors food and hygiene inventories. · Assures that safety and sanitation standards are met in the kitchen and basement. Represents LESC to auditors from OASAS and CARF during audits of the kitchen and basement. · Liaisons with medical and clinical staff and develops educational programs for residents that include instructions on good nutrition, and meal preparations. · Maintains all appliances in working order and arranges for service for items in need of repairs. · Attends food show, seminars, and conferences and stays abreast of industry standards, products and safety regulations. · Supervises and trains clients in food preparation, sanitation and the rudiments of cooking. · Participates in the Health and Safety Committee. · Interfaces with private/public sanitation representative for timely removal of garbage from the facility. · Fills in for other staff on leave. · Performs other duties as requested or assigned. · Adhere to Department of Health and OSHA regulations regarding proper kitchen hygiene and maintenance · Ensure that quality and quantity of food meet standards for meal patterns established by designated regulatory agencies · Receive and inspect incoming food products for quality, quantity, and ensure prompt and proper storage · Prepare meals accurately according to the menu and recipes · Recommend menu changes to improve quality of food · Supervise and coordinate activities of clients engaged in food preparation, meal service, and cleanup · Ensure safe handling and proper temperature control of prepared foods · Maintain and report meal service data · Maintain monthly inventory · Submit food orders to vendors in a timely manner · Ensure security of refrigerators, freezers, food storage areas · Ensure cleanliness and sanitation of kitchens · Supervise and participate in the training of clients · Conduct inspections of kitchen facilities to ensure cleanliness and proper food storage · Perform additional duties as assigned SCHEDULE: Wednesday - Sunday 8AM-4PM RATE: $40,000 - $41,605 / yearly dep. on experience LOCATION: NY, NY 10002 We offer excellent benefits including: • Generous time off that includes 4 weeks of vacation, • Medical, Dental, and Vision Insurance, • Discounted Commuter benefits, • Life insurance & Long term disability, • Eligible for Federal Student Loan Repayment Program Please visit us at EEO Minorities/Women/Disabled/Vet Requirements: QUALIFICATIONS - EDUCATION AND PROFESSIONAL EXPERIENCE: • High School Diploma, GED and/or a satisfactory equivalent combination of education and/or training and experience., • Food Handlers’ License., • Five years’ experience in management of health care or food service type setting or satisfactory equivalent combination of education and/or training experience in cooking and nutrition., • Must be able to lift up to 50lbs., • Must be computer literate. Compensation details: 40000-41605 Yearly Salary PI7fb38c353b51-25405-39974261

Job Description ABOUT ORGANOX: OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Product Quality Engineer to join our team. Position Summary The Product Quality Team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance, in addition to owning quality processes within the service organization. The Product Quality Engineer will be technical, hands-on, and customer focused with an ability to analyze, diagnose and test product quality issues. The successful candidate is accountable, collaborative, has excellent communication and problem solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer. Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive. This is a flexible, on-site role in our Madison, NJ facility. Requirements Requirements Major Responsibilities Under direction from the Senior Product Quality Engineer, the Product Quality Engineer will: · Conduct hands-on analyses of returned products to identify root causes of failures · Develop investigation criteria and test methods to properly diagnose and root cause field failures · Analyze and trend on product performance data to provide recommendations for product improvements · Perform Quality trending of Service data and conduct investigations to identify causes of Servicing and Service-related complaint trends, including issues in Servicing workmanship and Out of Box failures. · Review the output of Servicing and related Complaint or Non-Conformance Investigation activities to ensure that the resulting work complies with all regulatory and service requirements, as well as facility, divisional, and corporate objectives for defect prevention and continuous improvement. · Audit and review Complaint Investigations and records of Servicing activities to ensure they are thorough, accurate, self-explanatory, and completed in a timely manner into the complaint handling system. · Analyze service-related PFMEAs and other activities to support pre-market and post-market risk management activities · Provide ongoing training to Service staff on regulatory requirements associated with complaint investigations and Servicing records · Foster supplier relationships and support Supplier corrective action requests · Support Product Transfer teams by aligning on quality requirements and processes for new or transferred products · Plan, develop, and conduct Service Manual and Service work instruction validations (IQ, OQ, PQ), test method validations, and inspection method validations · Participate in the development and review of engineering change orders that impact servicing activities · Work with Engineering to design and implement tooling and fixturing required to perform servicing activities and implement error-proofing (Poke-Yoke) in those stations · Work cross-functionally to support implementation of changes in servicing and inspection procedures to mitigate field failures. · Support CAPAs, Escalations, DCNs, and other engineering projects to address and resolve field quality issues, ensuring timely implementation and compliance with quality standards · Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations · Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies. While the above key responsibilities are the main elements of the titled job the Vice President Quality may at times request other tasks deemed to be within their capabilities. Skills and Experience · Excellent technical report writing skills · Strong Root Cause Analysis, Design Of Experiments, and test method development experience as related to Service activities and complaint or non-conformance investigations · Experience in leading investigations and trending analysis, leveraging expertise in troubleshooting electro-mechanical systems and engineering custom test fixtures and apparatuses for functional and performance validation · Ability to manage multiple investigations and projects independently. · A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives. · Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.) · Strong experience with statistical analysis of data. Experience with Minitab preferred. Experience with Six Sigma principles preferred. · Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills · A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations. · Strong focus on meeting customer needs. · Ability to work with cross-functional teams. · Ability to be self-driven and solve complex problems independently. · Demonstrated strong attention to detail and “do it right the first time” attitude Qualifications · Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience · 3-7 years of related hands-on engineering experience in the medical device industry, or equivalent. · Ability to travel 10-20% · Strong background in troubleshooting electro-mechanical systems and interpreting electrical schematics and circuit diagrams · Experience using diagnostic tools such as digital multimeters and oscilloscopes, as well as developing and validating test methods for components including PCBs, motors, pumps, power supplies, and batteries · Prior experience in implementing new processes and driving improvements. · Experience in a customer focused Service organization is a plus · Familiarity with ISO14971 and associated Risk Management Processes is a plus · Knowledge of and/or experience with product decontamination and Blood Borne Pathogen exposure controls is a plus · Experience in an FDA regulated environment is a plus A job description does not imply that the duties stated are the only ones to be performed by the job holder. Employees will be required to follow any other job-related instruction as requested by their manager. Benefits At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Job Description About Synchron Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. About the Role We are seeking a Senior Quality Systems Engineer to play a key role in the maintenance and optimization of Synchron’s Quality Management System (QMS). This individual will apply systems thinking and regulatory knowledge to implement and continuously improve quality processes that support Synchron’s product development and clinical operations. This role will work cross-functionally to ensure quality processes are compliant and effective. We are looking for people with experience working within FDA regulated industries (preferably medical devices) who are comfortable operating in a fast-paced environment. Synchron is a patient first company full of mission-driven people with a passion for problem-solving and doing right by our patients. If this sounds like you, then we invite you to apply! Job Location Brooklyn/New York City (on-site) Job Responsibilities QMS Administration and Process Development • Serve as the primary administrator for Synchron’s Arena eQMS including system configuration and account management, • Drive the maintenance and development of existing and new SOPs/processes to meet business needs in alignment with 21 CFR 820, ISO 13485, and applicable regulatory requirements, • Own the Document Control function by processing change requests/orders and driving continuous improvement to the process, • Own the execution of processes associated with clinical product handling including product receiving, inventory management, distribution, and returns, • Support Quality Management Reviews by preparing data and information for the review, • Support internal and external audits including preparation, execution, and resolution of audit findings, • Use risk-based thinking and a creative problem-solving mindset to improve quality tools and processes, • Foster a Culture of Quality through collaboration, teamwork, and a drive for change and continuous improvement, • Bachelor’s degree in engineering, life sciences, or a related field, • 5+ years of experience working within a Quality Management System in an FDA regulated industry e.g. medical device, pharmaceutical, or biotech, • Knowledge and understanding of medical device Quality Management Systems and applicable regulations and standards including 21 CFR 820 and ISO 13485:2016, • Experience using an electronic Quality Management System (preferably Arena), • Demonstrated ability to perform detail-oriented work with a high degree of accuracy, • Excellent time management, organizational, and planning skills, • Effective written and oral communication skills, • Must work effectively within teams with rapidly changing priorities, • Experience with class III medical devices in an area such as neuromodulation, vascular devices or cardiac rhythm management, • Experience participating in quality inspections and performing supplier quality audits, • Experience supporting investigational devices undergoing clinical trials, • ISO 13485:2016 Lead Auditor Certification Compensation The base salary range for this role is [$120,000 – $160,000], depending on experience, skills, and qualifications. In addition to base pay, this role may be eligible for discretionary bonuses and/or equity grants subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position currently. Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible • Subsidized medical and dental insurance coverage for you and your dependent(s), • Life insurance, short-term disability, long-term disability, • 401k, • Discretionary unlimited PTO, • Flexible Spending Account for you and your dependent(s), with eligible plan elections, • Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply and now and build the future with us.

Job Description Who We Are: Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click's treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click's platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit and connect with us on LinkedIn. About the Role: We are looking for an entrepreneurial Lead Product Manager to own the end-to-end vision and success of our Migraine Product Portfolio, including the flagship CT-132. Your primary focus will be on the Over-the-Counter (OTC) FDA-regulated product, but will oversee the prescription (Rx) and wellness versions of the product as well. This is a 0-1 product role. You are not just managing an existing product; you are helping to define the commercialization blueprint for a new category of consumer healthcare. You will navigate the intersection of clinical rigor, regulatory strategy, and best-in-class consumer user experience to find and scale product-market fit. This position is based out of Click's headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities. We have a hybrid working model that consists of at least 4 days in office each week. Responsibilities: • Vision & Strategy: Define the North Star & Vision for the Migraine product. Align cross-functional teams (Science, Engineering, Design, Regulatory, and Commercial) around a roadmap that balances FDA requirements with consumer engagement. Understand scientific concepts and identify opportunities to translate ideas into testable, scalable products and prototypes., • 0-1 Commercialization: Identify market drivers, define the MVP for the OTC launch, and iterate quickly based on user data to achieve commercial scale. Partner and support commercial and marketing teams to influence GTM strategy and approach., • Cross-Functional Leadership: Work in collaboration with scientific, commercial, and engineering leaders to rapidly define and develop features that increase product performance, deliver therapeutic value to our patients & our partners., • Data-Driven Decision Making: Advance our practice of utilizing clinical, behavioral, and sensor data to drive insights. Ensure the product meets deep subject matter expertise requirements in market dynamics and clinical strategy., • Product Excellence: Own the delivery of business outcomes. Actively mentor other Product Managers and raise the standards of the PM practice at Click through improved processes and collaborative culture., • 8+ years of Product Management experience, with a proven track record of launching 0-1 products in the Consumer Healthcare, HealthTech, or MedTech space. Experience developing mobile applications., • Demonstrated ability working with a cross-functional product development team to find product-market fit for a new product line and successfully lead it through commercialization and scaling., • Proven ability to manage a portfolio of products or a large offering, rather than a single feature set. You have successfully defined end-to-end solutions that impact the company as a whole., • Expert-level proficiency in PM fundamentals (user research, technical architecture, business analysis) and a "biased for action" mentality in a fast-paced environment., • Excellent verbal and written communication skills, demonstrated through the creation of strong presentation materials, with ability to translate complex technical concepts to non-technical and executive audiences., • Familiarity with AI tools and products, such as Replit, Claude Code, Gemini, etc., • Experience working within regulated environments (FDA, HIPAA, etc.) is highly preferred. Familiarity with the complexities of digital health claims and clinical endpoints is a strong plus., • Experience working with technologies including, but not limited to ReactNative, Node.js, AWS. Proficiency with SQL and Mixpanel. The base salary range for this position is between: $160,000 - $200,000. The final base salary will be dependent upon skills, experience and location. In addition to the base salary, Click Therapeutics offers an annual performance-based cash bonus and a generous equity package. Benefits: The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space. Competitive Salary with Annual Review | Cash Bonus | Stock Options | 5% 401(k) matching | Medical | Dental | Vision | Life Insurance | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fertility Support | Fitness Reimbursement | Bike Membership | Professional Development Stipend | DoorDash and Catered Lunches | Parent Benefits | LinkedIn Learning | Gemini Enterprise Stack | Industrious Workspaces | Commuter Subsidies | Flexible Work Arrangement | Choice of Mac or Windows | Sponsored Company Events | Office Snacks and Beverages | Much More… Equal Employment Opportunity: Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics. Recruitment Phishing Scams: Fake job advertisements and offers are increasingly appearing on the internet. If you have encountered a job posting or have been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond and report it to the Federal Trade Commission and the FBI at . Please be mindful of the following: • Click Therapeutics will only reach out to you through an "@clicktherapeutics.com" email address., • Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver's License Number) via a messaging application (like that used on the LinkedIn platform or Microsoft Teams)., • Click Therapeutics will conduct interviews face-to-face over Zoom., • All job postings will be listed on the Click Therapeutics official career page.

Job DescriptionAt Rowan, we are all about making ear piercing experiences a celebration full of joy! Rowan is an innovative ear-piercing and hypoallergenic jewelry brand that brings safety to the forefront with our team of licensed nurses – and celebration to every customer with our joyful approach to piercings and jewelry. Our priority is to offer a fun, celebratory, and safe ear piercing experience for everyone. When we say piercing for all, we mean it. Everybody is invited to this ear party! The Associate Buyer is detail-oriented and responsible for managing assortment and selection recommendations for jewelry and ear piercing products. This role reports directly to the CSCO and requires a strong understanding of consumer preferences, and quality materials, metals and gemstones in the jewelry space. The ideal candidate will play a key role in supporting the curating of a compelling product assortment that aligns with our brand identity and incorporates a deep understanding of our customer—not just market trends, but the specific styles and preferences of those we serve through our piercing services. By leveraging direct customer interaction and store team insights, this individual will make informed, customer-first buying decisions that reflect customer demand and enhance the post-piercing experience.Strategic Buying & Merchandising • Execute the approved seasonal buying strategies that align with company revenue goals and fashion trends partnering with vendors to produce the best products at targeted company costs, • Analyze and report sales data, competitive market trends, and customer insights to guide product decisions and potential style pricing strategies that align with company margin and sales targets, • Validate piercing ramp style compliance by reviewing studio ramp photos with each new roll out, • Monitor inventory levels and coordinate restocks, seasonal updates, and new product launches., • Inform studio operations, marketing and creative teams about delivery timing for both new deliveries and key replenishment, keeping the teams updated to any changes to assortment strategy or deliveries on a weekly basis, • Analyze ramp selling thru DOMO reporting and report out on performance monthly, • Analyze customer buying behavior and sales trends leveraging DOMO reporting to help inform product selection and purchasing strategy, • Plan and execute customer feedback sessions / with appropriate customers for new products - report on these efforts to help inform best options in order to hit sell through targets and improve jewelry percentage to topline, • Build and maintain strong relationships with jewelry vendors and piercing suppliers, and negotiate costing and delivery timing, • Work with closely with vendors on translating inspiration decks into assortments either thru vendor line sheets or thru development and approval of CAD’s, • Track and maintain spending within sample budget, • Maintain accurate tracking of all product samples, ensuring timely check-in and that the sample closet remains organized, well-maintained, and easily accessible at all times., • Support the sourcing for new vendors to cast a wider net on suppliers, • Gain a deep understanding of our customer—not just general trends, but the specific styles and preferences of those we serve—by working directly in our studios, hosting customer focus groups, and analyzing insights from our marketing CRM data.Trend & Market Research, • Stay at the forefront of jewelry and ear piercing trends, scouting emerging designers, and monitoring competitor assortments online and in stores., • Provide insights and recommendations to inform future collections and exclusives., • Stay ahead of jewelry and piercing trends by researching fashion forecasts, visiting Rowan studios monthly to elicit customer feedback on assortment and opportunities, competitive shopping once a quarter to ensure Rowan continues to take market share., • Work closely with marketing and visual merchandising teams to support product campaigns and in-store/online displays. Driving the product used in marketing campaigns., • Ensure all piercing jewelry meets safety, material, and regulatory standards (e.g., hypoallergenic metals, ASTM, or FDA compliance)., • Track KPIs such as sell-through rate, margin, and stock turnover to drive performance and make data-informed decisions., • Prepare buying reports and presentations for internal stakeholders., • Prepare PK knowledge decks and videos for Studios teams for each new collection launch, • Prepare executive presentations and decks for the CEO and other leadership team members on product strategies inclusive of but not limited to classification,age demographics, metal types and vendor roadmapWhat You Offer:, • Bachelor’s degree in Fashion Merchandising, Business, or a related field., • 2+ years of experience in retail buying, ideally in fashion accessories, jewelry, or piercing-related products., • Strong knowledge of jewelry materials (e.g., gold, titanium, stainless steel) and piercing industry standards., • Strong negotiation and vendor management skills., • Highly organized with strong analytical and Excel skills., • Passion for fashion trends and jewelry design., • Strong organizational and multitasking abilities., • Knowledge of health and safety regulations, particularly related to piercing, is a plus., • Excellent verbal and written communication skills., • Proficient working in Google Suite (Calendar, Gmail, Sheets, and Documents)., • Analytical skills, including basic retail math,calculating margin, inventory on-hand, tracking sales., • Experience working with global jewelry suppliers or independent designers., • Knowledge of ethical sourcing practices and sustainable materials., • Familiarity with POS and inventory management systems (e.g., Shopify, NetSuite,Domo).Full-Time Benefit + Perks:, • Medical/Dental/Vision Health Plans, • Long-term Disability, • Life Insurance, • 401k and Roth IRA Plans, • Paid Parental Leave, • Open PTO policy

Job Description Job Title: Quality Improvement Compliance Monitor Grade: 28 Salary: $109,145 - $117,588 The Research Foundation for Mental Hygiene is seeking a qualified candidate to fill a full-time Quality Improvement Compliance Monitor position. Reporting to the QIE Director and part of the greater HRPP, the incumbent will conduct site initiation visits and post-approval monitoring reviews of human subject research projects to ensure compliance with federal regulations and guidelines and NYSPI policies. Reviews often focus on, but are not limited to, review of recruitment practices, potential participant screening, adherence to eligibility criteria and the protocol, informed consent procedures, participant safety, document storage, and confidentiality of data. Note: This is a hybrid role with 50% on-site requirement Duties and Responsibilities: • Conducting for-cause audits authorized by the IRB or institutional official., • Writing reports and communicating findings with investigators, compliance committees, and appropriate parties., • Conducting education and training throughout the monitoring process with the ability to recommend further training to the human research education committee., • Providing regulatory guidance to the NYSPI research community. Assisting with site or study-specific research self-assessments., • Bachelor's Degree, • Previous experience as a member of a research team (i.e., study coordinator/research assistant), • Thorough knowledge of state and federal codes (Revised Common Rule, FDA, etc.) regarding research., • Considerable knowledge of Good Clinical Practice (GCP), • Certification as a Clinical Research Associate (CCRA) or SOCRA Certified Clinical Research Professional (CCRP), • Advanced computer/technical skills, • Strong organizational skills To Apply: Submit an application through our website at . Please note only applications submitted through our website will be considered. The Mission of the Research Foundation for Mental Hygiene, Inc. (RFMH) is to promote the mental health of all New Yorkers, with a focus on providing hope and supporting recovery for adults with serious mental illness and children with serious emotional disturbances. Applicants with lived mental health experience are encouraged to apply. RFMH is deeply committed to supporting underserved individuals, organizations, and communities. To this end, RFMH is focused on implementing activities and initiatives to reduce disparities in access, quality, and treatment outcomes for underserved populations. A critical component of these efforts is ensuring that RFMH is a diverse and inclusive workplace where all employees' unique attributes and skills are valued and utilized to support the mission of the Agency. RFMH is an equal opportunity/affirmative action employer. The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees, do not participate in any state retirement system, and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action/Equal Opportunity Employer - Disabled/Veteran, 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a) compliant. Job Posted by ApplicantPro

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL) at Compass Pathways is a core member of the Medical Affairs organization, connecting the company's science with the broader mental health and neuroscience community, helping to shape medical strategy, and supporting the continued development of Compass Pathways' work in treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). This role is responsible for developing and managing a geographic territory and serving as a key scientific point of contact through both virtual and face-to-face interactions. The ideal candidate is passionate about a field-based role establishing themselves as a key point of scientific contact, actively engaging in high-quality scientific exchange and gathering insights from the field on emerging research, changes in the treatment landscape, and evolving approaches to care. Reports to: Director, Medical Science Liaisons. Location: Remote in NY Metro+ (Manhattan, Long Island, Brooklyn, PA, NJ, MD, DE) or hybrid in our NYC office. Roles and responsibilities: (include but not limited to) • Develop and maintain scientifically grounded relationships with healthcare professionals, researchers, and thought leaders across neuroscience and mental healthcare within the assigned territory, • Lead in-depth, compliant scientific conversations focused on disease understanding, research methodology, and emerging evidence in treatment-resistant depression and PTSD, • Anticipate and address scientific questions from external stakeholders by providing accurate, balanced medical information in response to unsolicited requests, • Collect, analyze, and communicate medical insights from the field to internal stakeholders to inform clinical development, medical strategy, and educational planning, • Maintain a high level of scientific expertise in relevant therapeutic areas, competitive landscape, and emerging research through continuous -- sometimes self-guided -- learning, • Contribute to the planning and execution of medical education activities, advisory boards, and scientific congress engagements and presentations, • Uphold all ethical, regulatory, and compliance requirements in the conduct of field medical activities, • Collaborate cross-functionally with internal partners (e.g., Clinical Development, Government Affairs, Market Access), • Provide training to eventual sales and marketing teams, • For Senior MSLs: mentor and coach junior MSLs, support onboarding and training efforts, and contribute to broader medical affairs initiatives or special projects Candidate Profile: • Advanced scientific training with associated credentials (e.g., PhD, PharmD, PMHNP, MD), • Previous MSL experience is strongly preferred, • Preference for candidates with background/experience in neuroscience, psychiatry or psychology, • Ability to travel up to 75%, including overnight stays and weekends, as needed, • Candidate must reside within the geographic area, • Engaging and expert communicator of scientific information and representing core values to a diverse array of audiences, • Excellent verbal and written communication, listening skills, and emotional intelligence, • Proven experience of self-motivation, accountability, integrity & teamwork Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Join Our Team at Bergen New Bridge Medical Center!** We are dedicated to providing high-quality, compassionate care to our diverse community. As a leading healthcare provider, we offer a supportive and inclusive work environment. If you’re passionate about making a difference and thrive in a collaborative setting, Bergen New Bridge Medical Center is looking for a Mammography Technologist. Job Duties Performs and obtains high quality mammograms on all patients (i.e. In-Patients, Clinic or Private Outpatients); recognizes the need for and utilizes radiation protection measures as appropriate in accordance with departmental policies. As required, transports patients to and from mammography rooms. Assists the Radiologist with needle localizations. Properly utilizes all mammography equipment permitted within the scope of their license and within the realm of their training. Assessment, treatment and patient care responsibilities are delivered with a knowledge of patient growth and development and are appropriate to the ages of the patients served. Ability to perform and maintain quality management as required by the FDA and MQSA. Customer Service: respect, flexibility, knowledge, confidence, professionalism, pleasant attitude, patience and helpfulness. All responses should be timely, professional, caring, and respectful in accordance with Customer Service Performance expectations Maintains established departmental policies and procedures, objectives, quality assurance program, safety, environmental, and infection control standards. Assesses gaps in policies and procedures, and create necessary policies and procedures to fulfill these gaps. Understands and adheres to the Medical Center’s Code of Conduct. Familiar with the Medical Center’s Mission, Vision, and Values Statements. OTHER JOB DUTIES Develops all X-rays when required. Provides patient comfort (e.g., bedpans, blankets) as required. Performs required clerical work when necessary to maintain patient records. Maintains a clean and orderly environment to include; Mammography room and equipment, and Mammography processor and dark room. Informs appropriate personnel when equipment is in need of repair. Fulfills all continuing education requirements specified by regulatory agencies and Medical Center standards. Performs other related duties as required. BASIC COMPETENCIES Education/Licensure Graduation from an AMA approved School of Radiologic Technology; ARRT or Registry eligible. Current NJ license as a Licensed Radiologic Technologist. Mammography registry. American Heart Association Heart saver CPR/AED certification. Experience None Skills Good interpersonal skills. Speaks, reads and writes English to the extent required by the position. JOB SETTING/PHYSICAL DEMANDS Diagnostic Imaging Department; contact with staff, patients. Lifts, positions and/or transfers patients. Frequent prolonged standing. Lifts/moves x-ray equipment. Protective clothing worn: gloves, gown, lead apron. Salary commensurate with experience within posted range. $38.46-$43.07 DIFFERENTIALS EVE/NIGHT $2.40/ WEEKEND $1.75 We provide a comprehensive benefits package, including a competitive medical, dental, and vision plans. We prioritize work-life balance with a generous time off policy that includes ample vacation days, personal time, sick leave and nine paid holidays. Additionally, we are committed to the personal and professional growth of our employees, offering robust tuition reimbursement and continuing education programs to help support our employees ongoing development. Company DescriptionBergen New Bridge Medical Center, a clinical affiliate of Rutgers Biomedical and Health Sciences, is a 1,070 bed hospital located at 230 East Ridgewood Avenue in Paramus, NJ. Founded in 1916 to treat patients with contagious diseases, the medical center has grown to become both the largest hospital and licensed nursing home in New Jersey and the fourth-largest publicly-owned hospital in the nation. A safety net facility, Bergen New Bridge Medical Center, renamed in October 2017, provides high-quality comprehensive services including long term care, behavioral health care, substance abuse treatment, and acute care to the greater Bergen County community. The medical center, including its Long Term Care Division, is fully accredited by The Joint Commission. With 323 behavioral health beds and 84 medical detox beds, Bergen New Bridge Medical Center is one of the largest medical facilities providing a continuum of care for those in need of behavioral health and/or substance abuse treatment. Please apply on our website: New Bridge Medical Center, a clinical affiliate of Rutgers Biomedical and Health Sciences, is a 1,070 bed hospital located at 230 East Ridgewood Avenue in Paramus, NJ. Founded in 1916 to treat patients with contagious diseases, the medical center has grown to become both the largest hospital and licensed nursing home in New Jersey and the fourth-largest publicly-owned hospital in the nation. \r\n\r\nA safety net facility, Bergen New Bridge Medical Center, renamed in October 2017, provides high-quality comprehensive services including long term care, behavioral health care, substance abuse treatment, and acute care to the greater Bergen County community. The medical center, including its Long Term Care Division, is fully accredited by The Joint Commission. With 323 behavioral health beds and 84 medical detox beds, Bergen New Bridge Medical Center is one of the largest medical facilities providing a continuum of care for those in need of behavioral health and/or substance abuse treatment.\r\n\r\nPlease apply on our website:

Job Description Auto-Chlor is now hiring an Electrical Engineer-Equipment Design to lead our engineering development initiatives. We’re looking for a leader who will contribute to our “People First” culture. This position would work in-office full-time at our facility in MEMPHIS, TN. What’s in it for you? RELOCATION ASSISTANCE OFFERED We understand that great talent can come from anywhere. That's why we offer: • Up to 60 days of temporary housing, • Reimbursement for moving and travel expenses, • Support with general relocation needs, • A people first culture where contributions and collaboration are encouraged and celebrated., • A competitive salary up to $150k annually with an excellent benefits package., • Ongoing wellness initiatives to improve your health and well-being. What are some of the day-to-day responsibilities? • Develops and implements solutions for dishwasher and dispensing innovation projects, including both new equipment development and existing equipment innovation. Projects vary in duration from two months to over a year based on Project Brief requirements., • Administers regulatory compliance with agencies such as NSF, CSA, UL, BOCA, ASSE, UPC, and Federal, State, and Local authorities. Provides support to the field sales team on regulatory issues, with an emphasis on maintaining customer equipment operation without disruption to business., • Provides technical support to field sales team, contractors, consultants, engineers, and architects., • Develops and manages technical documentation for design control and field use. Requirements: • Bachelor of Science in Engineering Degree or comparable years of work experience., • 5-10 years of electrical and electronic design experience, along with experience working with regulatory agencies. Experience in the commercial appliance industry is preferred., • Embedded Software/hardware design, • Knowledge of codes and standards for plumbing, sanitation, electrical, and building (NSF, CSA, UL, BOCA, ASSE, UPC, FDA), • Electrical/electronic circuit design, • CAD Modeling – Autodesk Inventor Preferred Location: 746 Poplar Ave Memphis, TN 38105 #PROFESSIONAL

Job Description About the Role: The Quality Manager supports the food safety and quality assurance function by managing day-to-day quality operations in a food manufacturing facility. This role ensures production processes, products, and documentation meet regulatory, customer, and certification requirements. The Quality Manager supervises inspection and testing activities, leads the quality team on the plant floor, and supports audit readiness, reporting directly to senior FSQA leadership. PCQI certification is required for this position. Responsibilities: * Supervise daily quality control and inspection activities, including raw material verification, in-process checks, and finished product release. * Serve as site PCQI, supporting Preventive Controls for Human Food programs in compliance with FSMA requirements. * Maintain and update quality documentation including SOPs, HACCP records, and batch production records. * Monitor sanitation verification, allergen control, environmental monitoring, and traceability procedures. * Ensure compliance with FDA, USDA, HACCP, GMP, and customer quality standards. * Lead, train, and coach quality technicians and inspectors to uphold consistent quality practices. * Support FSQA leadership during third-party, regulatory, and customer audits by maintaining audit readiness and documentation. * Track and report quality metrics, investigate deviations, and implement corrective and preventive actions. * Collaborate with operations, R&D, and supply chain teams to address quality concerns and improve processes. * Promote a culture of food safety, quality, and continuous improvement across the production floor. Qualifications: * Bachelors degree in Food Science, Microbiology, Chemistry, or a related field. * PCQI certification required, with demonstrated application in food manufacturing. * 3-5 years of quality assurance or food safety experience in food or beverage manufacturing. * Knowledge of FSMA, HACCP, GMP, and FDA/USDA regulatory requirements. * Strong experience supervising quality technicians and overseeing plant-floor quality operations. * Proficiency with root cause analysis, corrective actions, and quality improvement methods. * Strong communication and organizational skills, with attention to detail. Desired Qualifications: * HACCP or SQF Practitioner certification. * Experience with environmental monitoring, sanitation verification, and allergen management programs. * Familiarity with ERP or QMS systems for quality tracking and documentation. * Training in Lean Manufacturing, Six Sigma, or continuous improvement methodologies. * Ability to adapt to fast-paced production environments and support cross-functional teams.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert (SME) and Project Manager in the execution of Cresilon’s Preclinical Research Operations, including but not limited to in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy. This will include the development and execution of strategies for preclinical evidence necessary to competitively position a project’s product for domestic and international regulatory and clinical acceptance. This position as a hybrid role, with work off-site at CRO in NY/NJ area, work from home and on-site at Brooklyn NY. Job Responsibilities: The Preclinical Research Scientist will: • Lead, staff, and manage Cresilon’s Preclinical Research activities., • Provide preclinical scientific input and leadership on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life=cycle., • Plan, direct, coordinate, and execute activities related to the design, initiation. and follow-up of studies to support approval of Class I-III medical devices., • Develop, write, and/or review study protocols and repor-s. Act as a technical mentor for the development of study experimental designs, protocols, and reports of junior associates., • Administrate and manage Cresilon's preclinical regulatory strategy and communication., • Work with Contract Research Organizations (CROs) to execute both Biocompatibility / Safety and Efficacy/Functionality research, including negotiating, drafting, and managing research contracts and agreements with pre-clinical trial sites., • Ensure that the company operates within the scope of regulatory compliance including Quality System Regulations (ISO 13485), health and safety, environmental protection regulations, and the core values of Cresilon., • Be a Subject Matter Expert (SME) for the preclinical research department growth strategy. Actively interact with the internal and external scientific community to maintain state-of-the-art knowledge., • Oversee the development of and modifications to preclinical models to address project needs., • Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines., • Surveys the literature to identify and compare competitive product performance and safety risks., • Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP's, company policies, etc), • Work cross functionally with Regulatory and Quality to assess project risks, product safety and efficacy on NPD projects, including ensuring external facilities meet Cresilon standards for animal use and generating contracts and CRO audits, if necessary., • Manage budgetary requirements for all research projects to support efficacy and safety programs., • Lead the effort to publish surgical research in peer-reviewed journals., • Regularly interface with management to ensure research operations reflect overall corporate vision/strategy., • DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field is required., • Minimum 6+ years’ experience in preclinical medical device research is required, preference given to veterinary surgical or human surgical experience., • 4+ years of people management experience preferred., • Extensive knowledge of surgery, anatomy, toxicology, and pathology is required. Hands-on surgical experience is require., • Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred., • Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred., • Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations., • Experience with surgical publication submission strategy is strongly preferred., • Strong communication skills (both written and verbal) is required with the ability to extract key facts from complex information and present concise summaries to management., • Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required., • Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred., • Excellent problem solving, conflict resolution, and analytical skills is required., • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment is required., • Prior experience and ability to work well with external CROs and collaborators with professionalism and discretion is required., • Requires strong leadership and organizational skills including attention to detail and multi-tasking skills., • Able to understand and execute to project details but keep overall “big picture” view of projects, priorities, and strategies is required., • Medical Device product development experience, including knowledge of medical device regulations, regulatory/notified body requirements is preferred., • Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP), • Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is preferred., • Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred., • Legal authorization to work in the United States., • This position is located in Brooklyn, NY and may require up to 30% travel (to monitor and execute out-sourced studies) Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $130,000 - $210,000, depending upon job level and qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job Description Overview: Our client is a well-established, full-service international freight forwarder and customs brokerage firm recognized for providing tailored global logistics and supply chain solutions. With a strong reputation for reliability and customer satisfaction, they specialize in import/export operations across air, ocean, and ground modes — offering end-to-end visibility and compliance-driven support to a diverse portfolio of clients. Position Summary: We’re seeking a detail-oriented Customs Entry Writer with experience in U.S. import operations. The ideal candidate will be responsible for processing customs entries, ensuring regulatory compliance, and coordinating documentation for air and ocean import shipments. Experience with CargoWise is highly preferred. Requirements Responsibilities: • Prepare and process customs entries for air and ocean shipments in compliance with U.S. Customs and PGA regulations, • Review and verify import documentation (commercial invoices, packing lists, arrival notices, etc.), • Communicate with customers, carriers, and government agencies to ensure timely cargo release, • Classify shipments under the correct HTS codes and ensure accuracy in all data entries, • Maintain compliance with CBP, FDA, USDA, and other regulatory requirements, • 2+ years of experience in customs entry writing, brokerage, or import coordination, • Strong understanding of U.S. Customs regulations and HTS classification, • Proficiency with CargoWise or other logistics software strongly preferred, • Excellent attention to detail, time management, and communication skills Compensation & Benefits: • Competitive base salary (commensurate with experience), • Comprehensive benefits package including medical, dental, and vision coverage, • 401(k) with company match, • Paid time off and holidays, • Career growth opportunities within a stable and reputable organization

Job Description Position Summary: The Product Quality Team is a technical quality engineering team responsible for monitoring, understanding, and improving product performance, in addition to owning quality processes within the service organization. The Product Quality Engineer will be technical, hands-on, and customer-focused with an ability to analyze, diagnose and test product quality issues. The successful candidate is accountable, collaborative, has excellent communication and problem-solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer. Major Responsibilities: • Conduct hands-on analyses of returned products to identify root causes of failures, • Develop investigation criteria and test methods to properly diagnose and root cause field failures, • Analyze and trend on product performance data to provide recommendations for product improvements, • Perform Quality trending of Service data and conduct investigations to identify causes of Servicing and Service-related complaint trends, including issues in Servicing workmanship and Out of Box failures., • Review the output of Servicing and related Complaint or Non-Conformance Investigation activities to ensure that the resulting work complies with all regulatory and service requirements, as well as facility, divisional, and corporate objectives for defect prevention and continuous improvement., • Audit and review Complaint Investigations and records of Servicing activities to ensure they are thorough, accurate, self-explanatory, and completed in a timely manner into the complaint handling system., • Analyze service-related PFMEAs and other activities to support pre-market and post-market risk management activities, • Provide ongoing training to Service staff on regulatory requirements associated with complaint investigations and Servicing records, • Foster supplier relationships and support Supplier corrective action requests, • Support Product Transfer teams by aligning quality requirements and processes for new or transferred products, • Plan, develop, and conduct Service Manual and Service work instruction validations (IQ, OQ, PQ), test method validations, and inspection method validations, • Participate in the development and review of engineering change orders that impact servicing activities, • Work with Engineering to design and implement tooling and fixturing required to perform servicing activities and implement error-proofing (Poke-Yoke) in those stations, • Work cross-functionally to support implementation of changes in servicing and inspection procedures to mitigate field failures., • Support CAPAs, Escalations, DCNs, and other engineering projects to address and resolve field quality issues, ensuring timely implementation and compliance with quality standards, • Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations, • Adhere to the letter and spirit of the company's Code of Conduct and all other company policies., • While the above key responsibilities are the main elements of the titled job the Vice President Quality may at times request other tasks deemed to be within their capabilities. Skills and Experience: • Excellent technical report writing skills, • Strong Root Cause Analysis, Design of Experiments, and test method development experience as related to Service activities and complaint or non-conformance investigations, • Experience in leading investigations and trending analysis, leveraging expertise in troubleshooting electro-mechanical systems and engineering custom test fixtures and apparatuses for functional and performance validation, • Ability to manage multiple investigations and projects independently., • A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives., • Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.), • Strong experience with statistical analysis of data., • Experience with Minitab preferred., • Experience with Six Sigma principles preferred., • Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills, • A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations., • Strong focus on meeting customer needs., • Ability to work with cross-functional teams., • Ability to be self-driven and solve complex problems independently., • Demonstrated strong attention to detail and “do it right the first time” attitude Qualifications: • Bachelor's degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience, • 3-7 years of related hands-on engineering experience in the medical device industry, or equivalent., • Ability to travel 10-20%, • Strong background in troubleshooting electro-mechanical systems and interpreting electrical schematics and circuit diagrams, • Experience using diagnostic tools such as digital multimeters and oscilloscopes, as well as developing and validating test methods for components including PCBs, motors, pumps, power supplies, and batteries, • Prior experience in implementing new processes and driving improvements., • Experience in a customer focused Service organization is a plus, • Familiarity with ISO14971 and associated Risk Management Processes is a plus, • Knowledge of and/or experience with product decontamination and Blood Borne Pathogen exposure controls is a plus, • Experience in an FDA regulated environment is a plus

Job Description Direct Counsel is partnering with a premier technology and life sciences law firm seeking Associates for its rapidly expanding Life Sciences Technology Transactions practice. This group advises some of the most influential biotech, pharmaceutical, digital health, and emerging technology companies worldwide—helping them bring groundbreaking therapies and platforms from discovery to regulatory approval. About the Role The firm is seeking candidates with 2–4 years of experience handling: * Licensing agreements * Strategic collaborations & joint development arrangements * Commercial partnering transactions * Representation of biotechs and large pharmaceutical companies in transactions related to: * Novel therapeutics * Vaccines * Diagnostics * Digital health technologies * Clinical development and FDA regulatory pathways Experience working with AI-native or AI-driven life sciences companies—particularly those applying machine learning to drug discovery, diagnostics, or R&D—is a strong plus. This is an exceptional role for attorneys who want to: * Work directly with visionary founders and scientific leaders * Negotiate sophisticated standalone commercial deals that shape the future of medicine * Gain exposure to both life sciences and broader tech transactions work * Grow within one of the nation’s most respected technology transactions platforms Superior academic credentials and excellent written, oral, and interpersonal communication skills are required. Bar Requirements Candidates must be admitted to the bar in the state of the office applied to—or eligible to sit for or waive into the next bar exam. Compensation & Benefits * Base Salary Range: $235,000 – $310,000 * Discretionary performance-based bonus * Comprehensive benefits, including: * Healthcare * Life Insurance * Health Savings & Flexible Spending Accounts * Wellbeing programs * Salary is dependent on experience, qualifications, education, licensure, and office location. Why This Opportunity Stands Out You’ll have the chance to work at the intersection of science, technology, and innovation—supporting transformational discoveries and next-generation therapeutics. The team offers unparalleled access to highly sophisticated commercial work for cutting-edge clients shaping the future of health and technology. About Direct Counsel Direct Counsel partners with leading law firms and in-house legal departments nationwide to connect talented attorneys with outstanding opportunities. We take pride in matching professionals with roles that align with their expertise, values, and long-term career goals. Apply confidentially by sending your resume to

Job DescriptionCompany Description EVERSANA INTOUCH® is a global, full-service marketing agency network serving the life sciences industry, and is the first – and only – agency network to be part of a fully integrated commercialization platform through EVERSANA®. We provide next-generation creative and media services, enterprise solutions and data analytics services for clients. We get fired up when people talk about getting—and staying—healthy. That’s where we find our inspiration: in the very human experiences of patients, doctors, and even each other. Then, we collaborate on ways to make caring for one’s health more achievable, connecting patients and physicians with the information and tools they need. We embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. Job Description THE POSITION: The Associate Director, Medical has a deep understanding of the client’s business and demonstrates critical thinking and confidence while distilling the scientific and clinical data of the client’s brand(s), their competitors and clinical landscape into meaningful insights and strategic recommendations. This individual has the courage to take ownership and produces quality deliverables over multiple assignments, often concurrently. Your grasp of the scientific literature and ability to assimilate and transpose data beyond the context of the brand label are the keys to making recommendations to help solve complex business challenges. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: * Provide strategic input to guide creation of clinically relevant educational content and ensure effective use of clinical data to reach strategic brand objectives * Independent scientific content development including analysis and interpretation of clinical data across a wide range of project types * Conduct literature searches, proactively monitor competitive landscape and perform competitive analyses * Establish strong relationships with clients and proactively seek to contribute and collaborate in client meetings * Partner with internal teams to create compelling peer-to-peer educational content and engagement projects for healthcare professionals, including slide decks, KOL video, digital and print media * Establish close partnership with copy, art and digital teams to create interactive, engaging programs utilizing scientific storytelling techniques and unique data visualization * Collaborate to create and communicate Intouch’s POV and recommendations with clients * Play key role on team to educate team members on disease state, clinical trials, treatments and competition * Support submissions for client medical/regulatory approval processes and partners with all teams to incorporate client and regulatory feedback * Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. * All other duties as assigned Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability, unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources. PEOPLE LEADER: People leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values. In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities: * Responsible for and oversee their respective department. * Interview, select and supervise the activities of the department staff; communicate interpret and discuss with team the company policies and procedures. * Determine job objectives, work methods and performance standards; review performance relative to departmental objectives discussion appraisal with each employee and performance; authorize and communicate salary changes, promotions, transfers, discipline, and discharge and administer all other personnel actions. Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. * Advanced degree (PhD, MD or PharmD) in medical sciences related field required * Preferably two or more years of agency experience in medical education, medical communications and/or HCP marketing * Strategic thinker that understands how to effectively tell a scientific story in a compelling way to differentiate client products * Two years minimum medical writing experience required * Experience creating branded or unbranded peer-to-peer educational content * Expertise in extracting relevant information from clinical sources and writing medically accurate copy * Excellent verbal, written and organizational skills * Client-facing confidence that advances dialogue and creates strong agency-client relationships * Experience with complex projects that require collaboration between internal and external teams including key opinion leaders * Familiarity with FDA marketing regulations, AMA editorial style and digital PREFERRED QUALIFICATIONS: * Positive, problem-solving attitude * Someone who likes to have fun! Additional Information OUR CULTURAL BELIEFS: • Patient Minded I act with the patient’s best interest in mind., • Client Delight I own every client experience and its impact on results., • Take Action I am empowered and empower others to act now., • Grow Talent I own my development and invest in the development of others., • Win Together I passionately connect with anyone, anywhere, anytime to achieve results., • Communication Matters I speak up to create transparent, thoughtful and timely dialogue., • Embrace Diversity I create an environment of awareness and respect. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on LinkedIn | Twitter

Job DescriptionNow Hiring: Mechanics – Pharmaceutical ManufacturerPlease read the entire post; application instructions are located at the very bottom. ¡Sí, hablamos español! Shifts Available:1st Shift: 7:00 AM – 3:15 PM 2nd Shift: 3:00 PM – 11:15 PM 3rd Shift: 11:00 PM – 7:15 AM Pay Rate: $26.00 – $34.00 per hour (DOE) Locations: • East Hanover, NJ, • Whippany, NJJob Responsibilities:, • Perform preventative maintenance, troubleshooting, and repairs on production machinery and warehouse equipment., • Diagnose mechanical, electrical, and pneumatic issues to minimize downtime and ensure smooth operation of all production lines., • Assist with equipment setups, adjustments, and changeovers according to manufacturing requirements., • Inspect, maintain, and calibrate tools, machines, and mechanical components following company SOPs and GMP guidelines., • Document all maintenance activities accurately, including repairs, part replacements, and preventive maintenance logs., • Respond promptly to maintenance requests from production, packaging, or warehouse departments., • Ensure all equipment is operating safely and efficiently by following FDA, OSHA, and GMP regulatory standards., • Maintain an organized work area and support overall facility cleanliness and safety practices., • Collaborate closely with production, quality assurance, and engineering teams to resolve mechanical problems quickly.This role requires strong mechanical aptitude, problemsolving skills, and strict adherence to safety and quality standards in a regulated manufacturing environment.Requirements:, • Background check and drug test may be required., • Ability to work in a fastpaced, GMPregulated facility., • Must be able to use hand tools, diagnostic equipment, and follow mechanical diagrams., • Noise levels may range from moderate to high.What to Bring When Applying

Job DescriptionQC Analytical Compliance Investigator Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Our client is seeking a QC Analytical Compliance Investigator to lead life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field., • Experience in GMP Operations and/or QA in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • GMP Trained, Quality Systems Trained (Deviation/CAPA)Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Physical RequirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionJOB DESCRIPTION:The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience 2+ years of RadioPharmaceutical and Quality Assurance experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

Job Description Overview About Us: Anvia Therapeutics is a dynamic and innovative biotech company dedicated to developing small molecule inhibitors targeted at treating inflammatory and autoimmune diseases. We foster a collaborative environment where scientific excellence and creativity drive our mission to develop impactful medicines. Overview The Senior Director, Clinical Development Operations is responsible for providing strategic direction and operational excellence across all phases of clinical development programs. This key leadership role oversees the planning, execution, and oversight of clinical trials from early-phase through market filings, ensuring program objectives are achieved within established timelines, budgets, and quality standards. This position reports directly to the Chief Executive Officer. Responsibilities Essential Responsibilities Strategy & Leadership • Ensures clinical trial objectives are aligned with clinical development strategy and overall corporate strategy., • Generates progress reports and presents clinical program strategy and status updates to Senior Management., • Directs the planning and execution of clinical trials across all phases of development, from early development through NDA/regulatory submissions., • Accountable for clinical program and study timelines, budgets, and managing actual spend to approved budgets, including tracking actuals and communicating deviations., • Oversees quality and risk management of clinical development programs, ensuring adherence to SOPs, GCP, ICH guidelines, and FDA regulations., • Oversees the development and implementation of clinical trial systems and workflows (e.g., IRT/IXRS, central lab, eCOA) including design, specifications, and UAT., • Oversees full-service CRO and vendor management activities, including RFP, vendor selection, scope of work development, performance management, and vendor governance., • Authors and/or contributes to regulatory documentation and filings (e.g., IB, IMPD, IND) and correspondence with regulatory authorities and ethics committees., • Contributes to the writing, review, and finalization of clinical study protocols, Investigator Brochures, and clinical study reports., • Provides leadership, mentorship, and direction to the Clinical Development Operations team; responsible for recruiting, developing, training, and retaining top talent., • Ensures prioritization of activities and resourcing is aligned with clinical development program needs., • Develops and maintains company SOPs, work instructions, and training for Clinical Operations activities., • Constructively manages conflict within development teams and ensures timely resolution of issues., • Fosters a collaborative, highly integrated, and innovative team culture. Qualifications Qualifications • BA/BS in life sciences or a health-related field required, • Minimum 12+ years of progressive clinical operations and/or development operations experience within the pharmaceutical or biotechnology industry., • Demonstrated experience in clinical development programs and teams spanning early to late phase clinical development, • 5+ years of people management and leadership experience with a proven track record of building and developing high-performing teams., • Demonstrated working knowledge of ICH/GCP guidelines, data management, clinical systems, statistical programming, medical writing, pharmacokinetics/pharmacodynamics, protocol design, and drug product development and distribution., • Experience with global project teams and ability to work across multiple time zones and languages preferred., • Proficiency with MS Office Suite (Word, Excel, PowerPoint, Outlook, Project)., • Highly adaptable with the ability to thrive in a fast-paced, start-up or clinical-stage environment and develop creative solutions with limited infrastructure., • Excellent interpersonal skills with strong oral and written communication abilities., • Innovative, analytical, and highly organized with the ability to drive multiple projects to completion simultaneously., • Proven experience working at the senior management level and recognized as a strong leader in a high-science organization., • Willingness to travel up to 30%, as needed, to support clinical development programs. The salary range for this position is $200,000-$260,000 per year. The actual compensation offered will be based on factors such as relevant experience, education, and skills. In addition to base salary, we offer a comprehensive benefits package, including health insurance, paid time off, and retirement plan options. Our employment decisions are based on merit, qualifications, and business needs. We are committed to providing a work environment free from discrimination, harassment, and retaliation, and we undertake affirmative action efforts to promote equal opportunity for all employees and applicants. #LI-DNI

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters. Responsibilities • Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information., • Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions, • Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies, • Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings., • Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests., • Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions, • Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization, • Develops, implements, and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC., • Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company., • Trains, develops and mentors individuals; may include formal supervisory responsibilitiesQualifications, • Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject., • Preferred Education: Relevant advanced degree preferred. Certification a plus., • Required Experience: 8 years pharmaceutical with at least 3 years of demonstrated leadership, • Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing., • Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority., • Experience working in a complex and matrix environment., • Strong oral and written communication skills., • Note: Higher education may compensate for years of experience Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: Our Director, Product Communications leads the development and execution of communications strategies for our pipeline and future assets. This role is pivotal in shaping the narrative around our scientific innovation and rigour, managing reputation through clinical milestones, and preparing the external environment for a potential first-in-class commercial launch. The role partners with Commercial, Medical Affairs, Investor Relations, Patient Advocacy and others, to deliver consistent, compliant, and impactful messaging across earned, owned, and shared channels, ensuring our mission resonates with patients, providers, and payers. Location: Hybrid in our New York City office or remote on the east coast in the United States. Reports to: Vice President, Communications. Roles and responsibilities (Include but are not limited to): Strategic Product Communications • Lead the development and implementation of comprehensive product communication strategies to support our investigational product through Phase 3 data readouts, regulatory filings, and potential commercial launch, • Design and execute global communications programs that articulate the scientific and clinical value of our pipeline to media, HCPs, and patient communities, ensuring alignment with Compass's corporate narrative, • Partner with cross-functional teams including Commercial, Medical Affairs, Regulatory, and Legal to ensure all communications are compliant, accurate, and strategically aligned with business objectives, • Establish and manage relationships with key trade, healthcare and consumer journalists, • Develop high-impact materials including press releases, Q&As, key message documents, for clinical milestones and congresses, • Build and execute communications plans for launch readiness, creating disease state awareness campaigns in partnership with cross-functional team members that reduce stigma and educate stakeholders on treatment-resistant depression (TRD) and PTSD, • Collaborate with the Medical Affairs and Scientific Communications teams to amplify data dissemination at major medical congresses and through peer-reviewed publications, • Over 10 years of experience in pharmaceutical/biotech communications or public relations; agency and in-house experience preferred, • Proven track record leading product communications for a product launch, ideally as a first-in-class; CNS/psychiatry preferred, • Deep understanding of FDA/EMA regulations regarding drug promotion and scientific exchange, • Expertise in media relations with established contacts in biotech, healthcare and consumer sectors, • Proven track record of being an out-of-the-box and highly creative thinker, adept at building unique plans that reach stakeholders in new and different ways, • Cross-functional collaborator with excellent communication skills, able to navigate a matrixed environment across Commercial, Medical, and IR, • Adept at managing external public relations agencies and vendors, ensuring budget efficiency and high-quality execution of tactical plans, • Hands-on builder capable of setting strategy while executing tactical deliverables in a fast-paced, growth-stage environment, • Degree in Communications or Journalism; advanced degree preferred, • Mission-aligned, inclusive leader reflecting Compass's wellbeing-first, stigma free culture Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$190,000—$240,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job DescriptionCompany Description EVERSANA INTOUCH® is a global, full-service marketing agency network serving the life sciences industry, and is the first – and only – agency network to be part of a fully integrated commercialization platform through EVERSANA®. We provide next-generation creative and media services, enterprise solutions and data analytics services for clients. We get fired up when people talk about getting—and staying—healthy. That’s where we find our inspiration: in the very human experiences of patients, doctors, and even each other. Then, we collaborate on ways to make caring for one’s health more achievable, connecting patients and physicians with the information and tools they need. We embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. Job Description WHAT DOES A MEDICAL DIRECTOR DO? We are seeking an experienced and knowledgeable Director, Medical for our medical team. The ideal candidate will have a strong background in medical science, excellent communication skills, and a passion for translating complex medical information into impactful advertising. As the Director, Medical, you will be responsible for overseeing all medical content, ensuring scientific accuracy, and collaborating with creative and account teams to develop effective campaigns. * Consulting with Creative, Account and Planning teams to develop compelling medical content across all digital and print media * Identifying new medical advances and opportunities, and implementing disease state knowledge to drive promotional efforts * Analyzing clinical data, conducting literature searches, participating in medical conferences and performing competitive analyses * Engaging and informing colleagues, healthcare professionals and clients, including medical, legal and regulatory groups * Collaborating in the development of EVERSANA INTOUCH POVs and recommendations with clients * Ensuring medical communications and promotional pieces meet and surpass marketing team objectives * Guide the creation of clinically cogent and engaging promotional and KOL materials while ensuring effective use of clinical data to reach strategic brand objectives * Improve medical literacy across contributing agency teams; provide medical understanding on disease states, clinical trials, treatments and competition * Guide submissions for client medical/regulatory approval processes and help to incorporate client and regulatory feedback * Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. * All other duties as assigned Qualifications WHAT ARE WE LOOKING FOR? • M.D., Ph.D. or Pharm.D. required with 5+ years of experience in an agency or pharmaceutical industry supporting scientific communications, medical affairs or medical education A passion for science, medicine and innovation, with a proven track record of communicating medical advances to different audiences * Ability to lead and execute development of content, including data analysis for a wide range of complex projects with minimal review/direction * Ability to independently and accurately incorporate strategic concepts into projects, as well as the capability to guide others to do so * Understanding of clinical practice, with the ability to perform scientific literature searches; can interpret complex clinical data into compelling stories (copy) * Excellent verbal, written and organizational skills; insightful data analysis and accomplished presentation abilities, as well as the drive to build client and team relationships * Insightful with a problem-solving, solution-oriented mindset; comfortable with leading client interactions and defending work and opinions * Familiarity with FDA marketing regulations, AMA style and digital best practices * Willingness to travel is a requirement Additional Information OUR CULTURAL BELIEFS: Patient Minded I act with the patient’s best interest in mind. Client Delight I own every client experience and its impact on results. Take Action I am empowered and empower others to act now. Grow Talent I own my development and invest in the development of others. Win Together I passionately connect with anyone, anywhere, anytime to achieve results. Communication Matters I speak up to create transparent, thoughtful and timely dialogue. Embrace Diversity I create an environment of awareness and respect. Always Innovate I am bold and creative in everything I do. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on LinkedIn | Twitter

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Director of Omnichannel and Digital Strategy will play a critical role in designing and executing the company's digital engagement strategy to support the successful commercialization of Compass Pathways' therapies. This leader will be responsible for developing an integrated omnichannel ecosystem that enables personalized, data-driven engagement with healthcare providers and key stakeholders. This role will oversee the development and deployment of digital platforms, AI-enabled decision engines, and marketing automation capabilities that power next best actions, targeted email campaigns, and scalable digital content delivery. The Director will partner closely with Commercial Operations, Marketing, IT, Analytics, and external vendors to build and operationalize the digital infrastructure required to support a modern pharmaceutical commercial organization. The ideal candidate combines strategic thinking with hands-on experience building digital capabilities, implementing AI-driven engagement tools, and managing cross-functional initiatives in a highly regulated pharmaceutical environment. Location: Hybrid in our New York City office or remote on the East Coast in the United States. Reports to: Senior Director, Commercial Operations. Roles and responsibilities (Include but are not limited to): • Develop and execute Compass Pathways' omnichannel engagement strategy to support commercial launch and long-term brand growth within the pharmaceutical market, • Design and implement digital ecosystems that enable personalized engagement across channels including email, web, CRM, field engagement tools, and marketing automation platforms, • Lead the development of next best action (NBA) capabilities using AI and advanced analytics to optimize healthcare provider engagement and field effectiveness, • Oversee digital campaign strategy including email marketing programs, triggered journeys, and audience segmentation aligned with pharmaceutical marketing standards, • Partner with Marketing and Medical teams to develop scalable digital content strategies and modular content frameworks that meet regulatory and compliance requirements, • Evaluate, implement, and manage digital platforms and software that support omnichannel engagement, marketing automation, and content management, • Collaborate with Commercial Analytics to integrate CRM data, behavioural data, and external healthcare datasets into engagement strategies, • Drive the adoption and optimization of AI-enabled tools that enhance personalization, predictive targeting, and campaign effectiveness, • Partner with IT and external vendors to build and deploy digital solutions while ensuring compliance with pharmaceutical regulatory, privacy, and data governance standards, • Develop measurement frameworks and dashboards to track omnichannel performance, campaign effectiveness, and customer engagement, • Support field teams by ensuring digital strategies integrate seamlessly with CRM workflows and sales execution, • Bachelor's degree in Marketing, Business, Data Science, Computer Science, or related field (MBA or advanced degree preferred), • 8–10+ years of experience in omnichannel marketing, digital strategy, marketing technology, or commercial operations within the pharmaceutical or biotechnology industry, • Demonstrated experience designing and implementing omnichannel engagement strategies in pharmaceutical commercial organizations, • Strong understanding of pharmaceutical marketing regulations and compliance requirements (e.g., FDA promotional guidelines, MLR review processes), • Experience implementing or managing marketing automation, CRM platforms, and digital engagement ecosystems commonly used in pharma environments, • Hands-on experience building or deploying AI-enabled tools or software capabilities that support next best actions, predictive targeting, or marketing optimization, • Strong understanding of data-driven marketing, customer journey orchestration, and campaign analytics in healthcare or life sciences, • Experience supporting pharmaceutical product launches or pre-launch commercial environments strongly preferred Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$190,000—$240,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: Our Senior Director, HCP Marketing will lead the development and execution of comprehensive healthcare professional engagement strategies to drive awareness, education, and adoption of COMP360. This role will be responsible for creating targeted HCP marketing campaigns, building strategic relationships with key opinion leaders and prescriber segments, and developing evidence-based educational initiatives that support launch readiness and commercial success. Location: Hybrid in our New York City office or remote on the east coast in the United States. Reports to: Chief Commercial Officer. Roles and responsibilities (Include but are not limited to): HCP and Consumer Strategy and Targeting • Develop and execute targeted HCP and consumer marketing strategies aligned with brand positioning and commercial objectives, • Lead HCP segmentation, targeting, and prioritization efforts in collaboration with Sales and Market Access teams, • Design engagement pathways optimized for different HCP personas including psychiatrists, primary care physicians, and institutional prescribers, • Design engagement pathways optimized for consumers and caregivers, • Create compelling, compliant educational content and promotional materials for HCP audiences that translate clinical data into practical insights, • Collaborate with Medical Affairs on KOL engagement strategy, advisory boards, and scientific communications to build clinical credibility, • Develop congress strategies, medical education programs, and peer-to-peer learning initiatives, • Lead omnichannel marketing strategy across digital, in-person, and virtual touchpoints to deliver personalized HCP experiences, • Drive digital marketing initiatives including HCP portals, email campaigns, social media engagement, and webinars, • Partner with Sales on field enablement, ensuring representatives have compelling messaging and materials for HCP interactions, • Build and lead a full cross‑functional marketing team, overseeing PME, Consumer, and Digital Marketing to drive cohesive strategy and execution, • Collaborate closely with Market Access to align HCP messaging with payer and reimbursement strategies, • Partner with Site of Care Marketing to ensure coordinated patient-provider messaging and journey optimization, • Work with Regulatory and Legal to ensure all HCP-facing materials meet compliance requirements, • 10+ years pharma/biotech marketing experience with demonstrated expertise in HCP engagement; CNS/psychiatry experience strongly preferred. Launch experience an asset, • Proven track record developing and executing successful HCP marketing strategies for specialty therapeutics or novel mechanism launches, • Deep understanding of HCP prescribing behaviors, clinical decision-making, and healthcare professional networks, • Bachelor's degree in life sciences, marketing, or related field; advanced degree or MBA preferred, • Strong expertise in omnichannel marketing, digital engagement platforms, and medical marketing in regulated environments, • Excellent scientific acumen with ability to translate complex clinical data into compelling HCP messaging, • Experience collaborating with Medical Affairs, Sales, and Market Access in launch environments, • Outstanding communication, stakeholder management, and cross-functional influence capabilities Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$250,000—$330,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Our client in Fairfield, NJ is looking for an onsite, direct hire Manufacturing Industrial Engineer. Pay: $120k-$130k The ideal candidate will have an engineering background in mechanical engineering, industrial engineering, systems engineering, value engineering, or related engineering field with concentrated technical knowledge and previous experience in precision metals and plastics manufacturing and/or complex finished device assemblies. Responsibilities: • This role is fundamentally based on long-standing best practices in industrial engineering principles: identifying waste, defining value streams, productivity optimization, kanban setups, takt time studies, labor tracking, ergonomics, material flow, pFMEA, and similar Lean Six Sigma tools., • Support new business development with the purpose of generating accurate and detailed costing proposals that exceed customer expectations for quality, price, and delivery., • Bachelor's degree in Engineering (Mechanical, Industrial engineering, Systems engineering, Value engineering), • Minimum of 5 years of experience in value engineering, industrial engineering, manufacturing costing, or related role in the manufacturing industry, with specific experience utilizing industry 4.0 best practices and/or Lean, • Experience working for a Contract Manufacturer or OEM, • Strong engineering background with a solid understanding of manufacturing processes, materials, and equipment, • Ability to identify the best possible manufacturing processes, • Proficiency in using SolidWorks or equipment CAD/CAM software packages for estimating and DFM purposes, • Experience in product level design for manufacture (DFM), • Ability to collaborate across engineering Centers of Excellence for multi-plant vertically integrated proposals, • Excellent analytical and problem-solving skills, • Strong attention to detail and accuracy, • Effective communication and interpersonal skills, • Ability to work independently and as part of a cross-functional team, • Knowledge of industry standards and best practices in cost estimation

Job DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAbout MMS Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. Applicants must be legally authorized to work in the U.S. for any employer; we cannot sponsor visas (e.g., H-1B) or offer work authorization transfers at this time. Job Specific Skills: • Mastery and trained on generating tables, listings, and graphs from clinical trial databases using SAS., • Utilizes System Development Life Cycle (SDLC) for programming deliverables., • Advanced user in SAS programming, SAS Base, and SAS Macros., • Advanced knowledge of E-Submission Standards, Guidelines and Regulations., • Mastery and trained on SDTM standards including ability to write specifications., • Advanced knowledge of ADaM standards including supporting specification writing., • Proficient with MS Office applications., • Advanced knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements., • Advanced experience with pooling of data sets for submissions., • Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP., • Lead study or small programming project teams.Job Requirements:, • Masters required for all Statistics roles., • Minimum of 5 years’ experience in Statistical Programming or similar field required., • Expert knowledge of scientific principles and concepts., • Reputation as emerging leader in field with sustained performance and accomplishment., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements. WWrkvz8zoZ

Job Description Robert Half is supporting a client in the healthcare sector seeking an experienced Healthcare Procurement Counsel to provide legal support for healthcare‑related contracting and procurement activities. This role will focus heavily on healthcare contracts, including clinical, operational, medical technology, digital health, and regulated vendor relationships, within a highly regulated environment. The ideal candidate has prior experience advising health systems, hospitals, health plans, academic medical centers, or healthcare‑adjacent public entities, with demonstrated strength in negotiating healthcare and technology agreements. Assignment Details Location: New York, NY (Downtown/Tribeca) Schedule: Hybrid — 4 days onsite (Mon–Thurs), remote Fridays Duration: 6+ months (potential for extension) Pay Rate: $85–$110/hour Responsibilities Healthcare Contracting & Procurement • Provide legal support for healthcare‑related procurements, including:, • Clinical and operational vendor agreements, • Medical devices and healthcare technology, • Digital health, telehealth, and data‑driven services, • Pharmacy, supply chain, and healthcare operations vendors, • Draft, review, and negotiate a broad range of healthcare‑focused agreements, including:, • Healthcare IT, SaaS, and cloud‑based platforms, • Data‑use, cybersecurity, and interoperability agreements, • Advise on healthcare regulatory considerations impacting procurement, including:, • HIPAA and healthcare data privacy requirements, • CMS and reimbursement‑related considerations, • FDA‑adjacent issues related to medical technology, • State and local (NYC) procurement rules, • Assist with the development and maintenance of healthcare procurement policies, templates, and workflows., • Juris Doctor (JD) from an accredited law school., • Active New York State Bar license (required)., • 4–8 years of experience drafting and negotiating complex commercial and healthcare‑related contracts, with a strong preference for experience in healthcare, life sciences, health IT, or regulated environments., • Demonstrated experience advising on healthcare procurement and vendor agreements, including clinical services, medical technology, digital health, and operational vendors., • Strong working knowledge of HIPAA, healthcare data privacy, CMS requirements, FDA‑adjacent considerations, and related regulatory frameworks impacting healthcare contracting., • Proven ability to negotiate sophisticated agreements involving technology, services, data use, and compliance‑driven risk allocation., • Comfortable operating in a fast‑paced, highly collaborative, stakeholder‑facing environment supporting clinical, operational, and business teams., • Experience with public‑sector or quasi‑public procurement environments highly preferred., • Excellent written, verbal, and interpersonal communication skills., • Ability to operate independently while partnering effectively with senior leadership and cross‑functional teams., • Prior in‑house or advisory experience within a healthcare provider, hospital system, health plan, nonprofit health organization, academic medical center, or research institution., • Strong familiarity with healthcare technology contracts, including SaaS, cloud platforms, cybersecurity, interoperability, and data‑sharing arrangements., • Understanding of healthcare reimbursement structures, managed care models, value‑based care initiatives, or payer/provider dynamics.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionReports to: GCOQ – Global Chief of Quality (Functional/Global Alignment) Department: Quality Assurance / Quality Control Supervises: Regulatory Associates, Technicians Organizational Relationships: QA/QC, Production, Warehouse, Engineering, R&D, Sales Project Managers, Account Executives, Operational Personnel, Customers, Regulatory Agencies, External Vendors/Suppliers, Global Quality Teams Responsibility Summary: The Manager – Regulatory is responsible for supporting site regulatory operations while ensuring alignment with global regulatory strategy and corporate quality standards. This role oversees regulatory compliance, submissions, raw material management, and cross-functional coordination to ensure full adherence to applicable global regulations. The position serves as the primary regulatory lead for operational execution at the site and ensures effective communication between site operations and global quality leadership. Responsibilities: • Oversee issuance of Raw Material regulatory statements including Origin, REACH, Allergen, Nitrosamine-Free, EU/China compliance, and other global declarations., • Direct vendor communication and ensure timely collection and verification of regulatory documentation., • Review and approve compliance documentation (CoCs, CoAs, CoMs, BSE, CMR, SDS, RM documentation, etc.) for domestic and international requirements., • Support regulatory submissions related to Organic (USDA/Ecocert), Gluten-Free, MoCRA, CARES Act reporting, and other regulatory programs., • Oversee regulatory compliance documentation generated through internal and third-party systems., • Conduct regulatory review of formulas and ingredients to ensure compliance across all intended markets; proactively identify regulatory risks and implement mitigation plans., • Support the development, review, and maintenance of Product Master Files (Dossiers), Drug Master Files (DMF), and global regulatory submissions., • Support preparation, coordination, and response activities for regulatory inspections, cGMP audits, and environmental audits., • Ensure ongoing compliance with FDA (21 CFR 210/211/820), EPA, OSHA, TGA, Health Canada, ISO, EU, China CSAR, Japan, and other applicable global regulations., • Support regulatory-related SOP development, Change Control, and QMS compliance., • Monitor evolving global regulatory requirements and implement necessary updates to maintain compliance., • Provide regulatory leadership guidance to cross-functional teams and support global quality initiatives., • Act as regulatory delegate for the site, as required. Qualifications: • Bachelor’s Degree in Life Sciences, Engineering, or related field., • Minimum 5 years of regulatory experience in pharmaceutical, cosmetic, medical device, food or related regulated industry, • Working knowledge of FDA regulations (21 CFR 210, 211, 820), • Strong leadership, cross-functional influence, and communication skills, • Analytical and regulatory risk assessment capability Compensation & Benefits: • The approximate pay range for this position is $75,000 to $90,000 per year. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. Powered by JazzHR f3g5lWItFW