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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 DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • 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 have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. 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: The Manager, People Business Partner supports the delivery of key HR processes across the employee lifecycle, providing day-to-day guidance to managers and employees while coordinating activities such as recruitment, onboarding, performance management, and organizational change. By maintaining accurate HR data, supporting employee relations matters, and collaborating with cross-functional teams, the role helps ensure people processes run smoothly, remain compliant, and effectively support the organization's workforce and business objectives. Location: NYC/NJ or surrounding area. Hybrid working, 2 days a week in the office. Reports to: Associate Director, People Business Partner. Roles and responsibilities (Include but are not limited to): • Build strong relationships with managers and employees, providing day-to-day HR guidance and escalating complex matters where appropriate, • Attend stakeholder meetings where required to capture updates, support follow-up actions, and maintain awareness of team and business needs, • Assist with onboarding and offboarding processes, ensuring employee records, documentation, and internal systems are updated accurately, • Support organizational change activities such as restructures, Reductions in Force (RIF) and redundancies by coordinating documentation, preparing letters, and maintaining accurate records, • Assist in coordinating talent review processes, succession planning activities, and development planning initiatives, • Track potential flight risk indicators and support the implementation of retention or development actions as guided by the Associate Director, People Business Partner, • Support workforce planning processes by maintaining resource plans, tracking headcount changes, and coordinating updates between HR, Finance, and hiring managers, • Assist with recruitment processes including reviewing Job Requisition Forms (JRFs/TJRFs), coordinating approvals, and supporting the offer process, • Provide administrative and operational support for employee relations matters including performance management, conduct, and capability processes, • Assist with documentation and coordination of settlement agreements and other formal HR processes in line with company policies and legal requirements, • Support key moments in the performance cycle, including mid-year and end-of-year reviews, • Coordinate processes related to promotions, salary adjustments, equity allocations, and bonus administration in partnership with the People Operations team, • Draft and maintain HR policies and support the policy approval process, ensuring documents are uploaded and maintained in the Master Control (QMS) system, • Prepare and submit "Someone is Leaving" forms (SILs) and coordinate exit interviews, capturing feedback and identifying emerging themes, • Prepare Change Request Forms (CRFs) and ensure employee lifecycle changes are communicated and processed accurately, • Provide operational support across HR systems and employee lifecycle processes including performance management, and employee data management, • Assist with the coordination and tracking of leave of absence cases, ensuring employees and managers understand policy requirements and documentation needs, • Support payroll processes where required, including preparation of instructions to pay, • Contribute to HR and People Operations projects, assisting with planning, coordination, and implementation of new initiatives, • Assist with global mobility processes, including coordinating intra-company transfers, tracking application progress, and liaising with internal stakeholders and external advisors where required, • Previous experience in an HR, People Operations, or HR Advisory role, • Solid understanding of HR processes across the employee lifecycle including recruitment, performance management, employee relations, and offboarding, • Familiarity with employment legislation and HR best practices (US experience required; UK exposure beneficial), • Strong organizational skills with the ability to manage multiple priorities and deadlines, • High attention to detail and ability to maintain accurate and confidential records, • Excellent interpersonal and communication skills with the ability to build relationships with employees and managers, • Ability to handle sensitive employee matters with discretion and professionalism, • Strong problem-solving skills and the ability to identify process improvements, • Proficiency in Microsoft Office or similar tools (Excel, Word, PowerPoint) 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】:$126,000—$154,000 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 DescriptionHuman Resources ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Human Resources Business Partner will provide human resources consultation and support to assigned divisions. Understand business needs in order to assess the human resources implications of various business strategies. Acts as liaison to other functions to ensure achievement of business objectives. Provides staffing and placement support to departments and divisions. Facilitates the recruitment and on-boarding process for all new hires. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role will report to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups., • Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support., • Talent Acquisition: Designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry., • Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution., • Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values., • HR Expert: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures., • Compensation: Ensures our compensation practices continue to attract and reward top talent. Overseeing salary administration to include annual performance management and compensation processes., • Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies.REQUIREMENTS, • Bachelor’s degree in business, Human Resources or related field., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • 10 + years progressive HR/business leadership experience is required., • 5+ years in clinical and/or pharmaceutical industry., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • Prior experience in working in a matrix and complex operating environment preferred. fast paced, challenging industry., • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns, fast, while being adaptable to the changing environment., • Looks to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communications proficiency: for both written and verbal communication., • Works collaboratively with all levels of employees., • Works with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. Job Scope: The role of Sales Account Manager is to drive and support sales efforts in a given territory by implementing the sales/marketing strategies for GenScript products and services. The Sales Account Manager will use his/her knowledge of science and the business including corporate contacts to develop and deliver profitable initiatives and build sales. Please note that this position supports the New York / New Jersey territory and it is required to reside within the area. Key Responsibilities: The Sales Manager will be responsible for working with the Global Commercial Head to grow and develop an assigned sales territory for GenScript product/service lines and to achieve sales goals for the assigned territory. The Sales Manager will also work closely with their FAS, TAM team and MKT team to build the GenScript brand to meet the team's sales objectives. The Sales Manager will work 30% of the time doing quote and lead follow-up, account management and 70% of the time traveling in the field making customer visits and building relationships in order to achieve the agreed monthly/quarterly/yearly sales goals. • Work with Global Commercial Head to develop and implement territory sales strategies and tactics for products/services, new markets and new applications, • Responsible to understand the customer's research application and match GenScript services and products to align with the customer's research project requirements, • Share market knowledge with Sales, TAM and Marketing teams through weekly field feedback report, • Introduce GenScript to new markets – Industrial/Academic/Governmental., • Drive business expansion in collaboration with technical support team (TAM) and FAS, • Master's degree or above degree in scientific disciplines majoring in life science area; or Bachelor's degree with at least 2 years of lab experiences, • Relevant sales experience required (1-5 years) and a high level of technical and professional expertise, • Knowledge of the Biological and CRO or CDMO market or general biotech industry. Emphasis on Gene Synthesis, Protein, Peptide, Bioassays, Antibody and Cell Line Products/Services preferred, • Ability to operate effectively in an international business environment and the ability to succeed in such an environment, • Ability to accurately forecast sales within territory on a weekly basis, • Team player, • Strong analytical and time management skills. #LI-EB1 #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. Job Scope: The role of the Sales Account Manager is to drive and support sales efforts in a given territory by implementing the sales and marketing strategies for GenScript's custom life science services. The Sales Account Manager will use his/her knowledge of science and business including corporate contacts to develop and deliver profitable initiatives and build sales. This role will support the Northeast Territory for Academic customers. The ideal candidate resides in either Boston, MA or New York, NY areas. The estimated salary range is $80,000 - $95,000, based on experience level. Key Responsibilities: The Sales Account Manager will work with the Regional Sales Managers and Technical Solution Managers to grow and develop an assigned sales territory. They will promote GenScript's custom life science service lines and will be responsible for achieving the sales goals for the assigned territory. The Sales Account Manager will work 50% of the time doing account management, quote and lead follow-up, and 50% of the time traveling in the field making customer visits and attending virtual meetings. These customer engagements are crucial for building relationships to achieve the agreed monthly/quarterly/yearly sales goals. • Work to develop and implement territory sales strategies for services, new markets and applications, • Work cross-functionally to ensure all possible actions have been taken to secure business in a competitive environment, • Responsible for understanding the customer's research applications and matching GenScript's custom life science services with their project requirements, • Share market knowledge with Sales, TAM and Marketing teams through weekly field feedback reports, • Strong scientific background- either a Bachelor's degree or above majoring in life science area or equivalent experience, • Minimum of 2 years of experience in scientific or life science sales, • Knowledge of the Biological and CRO or CDMO market or general biotech industry. Emphasis on Gene Synthesis, Protein, Peptide, Bioassays, Antibody and Cell Line Products/Services preferred, • Experience in the lab is preferred, • Ability to operate effectively in an international business environment #LI-EB1 #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile 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. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility 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 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 Production Technician I is responsible for the aseptic manufacturing of Cresilon’s products for the animal health industry. The Production Technician II will be trained in clean room operations, aseptic techniques, and must demonstrate the ability to successfully pass gowning qualifications. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will have a proven track record of steady progress in a similar manufacturing environment and must possess a willingness to learn all equipment and jobs in the assigned manufacturing and sanitation of clean room facilities as required. Production Technicians are also responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP). • Perform line clearance of assigned production areas as required., • Perform equipment set up and disassembly activities., • Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling equipment, and packaging equipment., • Formulate, fill, and pouch product in accordance with SOPs., • Troubleshoot all operating deviations and issues and coordinate with other functions when required., • Report both machine and operating deviations to area supervisor or designee., • Perform routine, preventative maintenance on equipment., • Perform cleaning and disinfection of the manufacturing spaces., • Perform cleaning and sterilization of manufacturing equipment., • Perform visual inspection of components and/or product in accordance with SOP’s and cGMP’s., • Perform sampling, intermediate, and finished goods packaging as per SOPs., • Package and ship raw materials for sterilization., • Perform material receiving, staging, material movements, and material replenishment as per SOPs., • Transport samples, materials, and equipment between multiple facilities., • Complete data entry and generate reports for material inventory movements., • Complete and maintain applicable logbooks and batch record paperwork as required and in accordance with GMP and GDP standards., • Maintain a clean production environment during shift., • Report all actual, near misses and potential accidents for further investigation., • Take immediate action to resolve any near miss situations., • Assist in investigation of all actual, near misses and potential accidents. Provide information to troubleshoot and take initiative to resolve operational issues independently., • Assist in project commissioning and validation activities, as necessary., • Prepare samples or prototypes as required for testing, or other evaluations, • Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process., • Complete all required trainings: Read and Understand (TM1), Computer Based Training with Quiz (TM2), Instructor Led (TM3/TM4), and On-the-Job Trainings (TM5)., • Oversee training of junior employees on production processes as assigned., • Ensure proper communication and handling over of shift duties., • Support Environmental and Personnel Monitoring (EM/PM) activities as directed., • HS Diploma or Equivalent with 2+ years of relevant manufacturing experience in the pharmaceutical, biotechnology, or medical device industry OR 2 or 4 year degree with 0+ years of relevant experience., • Ability to read, understand, and execute written work instructions., • Ability to complete documentation accurately., • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals, • Ability to become gowning qualified to work in a cleanroom environment., • Ability to problem solve and achieve business objectives., • Ability to adapt training approach., • Willingness to be flexible, and open minded to new processes or changes in direction., • Team oriented, building relationships with peers and managers in a proactive manner., • Excellent verbal and written communication skills., • Proficient in Microsoft Office (Word, Excel, Outlook)., • 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, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Monthly MetroCard Reimbursement 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.

Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements, • Travel may be requiredREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Strong business acumen, • 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, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease 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 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 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 DescriptionResearch Intern (PhD), Machine Learning Join our team and help build the world's first biological reasoning model. Work with us to build generative foundational models that decode biological systems across scales — from molecules to organisms — enabling us to predict, understand, and program living systems in ways never before possible. Output Biosciences is currently in stealth, operated by a team of repeat founders and biotech veterans with multiple exits in AI and biology, and backed by top VCs including Y Combinator. Our internships offer flexible commitment, with a minimum of 20 hours per week, ranging 12 to 24 weeks. We have various start dates available to accommodate your academic schedule. There may be opportunities for full-time employment upon successful completion of your PhD. * You will contribute to the development of novel machine learning approaches for biological data analysis and interpretation * You will design and implement experiments to evaluate and improve AI models using large-scale biological datasets * You will collaborate with our interdisciplinary team to tackle complex challenges in molecular biology and drug discovery * You will present your research findings and contribute to publications in top-tier conferences and journals * You will have the opportunity to work on projects that directly impact the future of medicine and biotechnology Who We're Looking For * You are currently pursuing a PhD in Machine Learning, Computer Science, Computational Biology, or a related field * You have a strong background in deep learning, with experience in frameworks such as PyTorch or TensorFlow * You have a proven track record of research, demonstrated by publications at conferences such as NeurIPS, ICML, ICLR, or relevant computational biology venues * You are proficient in Python and have experience with large-scale data processing and analysis * You have excellent problem-solving skills and the ability to work independently on complex research problems * You are passionate about applying AI to solve real-world challenges in biology and medicine * You have strong communication skills and can effectively present technical concepts to diverse audiences * You thrive in a fast-paced, startup environment and are excited about making a significant impact in a growing field Bonus Points * Experience with biological data analysis or computational biology projects * Familiarity with generative AI models, such as transformers or diffusion models * Contributions to open-source machine learning or bioinformatics projects Our Values ❤️ Heart: We foster a culture of ownership. We are assembling a team of individuals who are passionate and take pride in their contributions. 🏆 Excellence: We have an unwavering commitment to excellence and continuously challenge ourselves to reach the highest standards. 🚀 Practicality: We value practicality and results-oriented thinking. We are committed to making a tangible impact on the lives of patients and the broader community. 📣 Honesty: We place a high value on honesty and directness. We firmly believe in addressing issues as they arise, in an open and transparent manner. 🎮 Fun: We believe that life is too short to not have fun. Our goal is to create a workplace that is fun, engaging, rewarding and fulfilling. What We Offer * We encourage new and different ideas, creativity and contrarian thinking * Healthy feedback focused environment to help you strive - leadership will have high expectations, regularly share constructive feedback, support you and help you grow, and welcome receiving feedback and ideas from you * You own your day-to-day management. What we care about is that we all hit our milestones * Competitive salary and equity in a growing, well-funded startup * Excellent medical, dental, and vision coverage

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile 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.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.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.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.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.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility 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 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 DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. 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, 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., • Manage 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 or equivalent experience., • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience., • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA, • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications, • Must be able to analyze data/information and to assess and resolve complex problems, • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing, • Knowledge of operational processes and controls in non-sterile and sterile operations, • 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., • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, 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. 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 DescriptionValidation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines in New Jersey. The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. • Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc., • Execute IQ/OQ and /or PQ protocols, • Prepare final reports for executed protocols, • Prepare final reports for vendor IQ, OQ and/or PQ protocols, • Review of executed IQ/OQ/PQ protocols and raw data, • Perform periodic review/requalification of validated equipment, systems and cleanrooms, • Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met, • Assembling validation related documents; and filing/archiving approved documents, • Maintaining electronic records.REQUIREMENTS, • BS/BA in engineering or a related Science discipline, • 3-7 + years of validation experience, • Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc., • Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11., • Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary., • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management., • Must be a dedicated self-starter with a high energy level and able to achieve results., • Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution., • Good time management skills to manage and meet deadlines., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment., • Good computer skills and Microsoft Office knowledge., • Ability to multi-task team is essential., • Flexible and able to adapt to company growth and evolving responsibilities., • Highly organized, detail oriented, and ability to manage multiple priorities., • Ability to perform the job under direct or indirect supervision, • Must have the ability to work in a team-oriented environment and with clients, • Must have the ability to work with specialized equipmentMay occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. 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.Ability to work in cleanroom environment for a moderate amount of time.Ability to lift, transfer, or ship validation equipment or related accessories.While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. Must where PPE when appropriate. 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 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 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, Product Quality provides strategic direction for Compass product manufacture and distribution through internal and external partnership development. This role ensures quality strategies across Compass operations and throughout the product lifecycle for all Compass products, maintaining alignment with GMP/GDP requirements. The Director, Product Quality also guides the Compass QMS to ensure processes adapt to changing business needs, company goals, and GxP regulatory requirements. Location: Hybrid in our New York City office or remote on the East coast, USA. Reports to: Vice President, Quality. Roles and responsibilities (Include but are not limited to): QA Expertise * Maintain oversight of current and evolving global regulatory requirements, proactively assessing impact to Compass products and developing remediation plans where required * Provide subject matter expertise in GMP and GDP, ensuring consistent application across internal and external operations Leadership * Drive enterprise Quality strategy across Supply Chain, Manufacturing, and QMS to reduce operational risk, optimize performance, and support the Compass business through growth and transformation * Lead, develop, and coach the Product Quality team, building strong Quality capability and enabling effective Quality partnerships across the organization * Act as the primary Quality point of contact for Compass Supply and Contract Manufacturing Organizations (CMOs) * Provide Quality support and oversight for Manufacturing and Supply, spanning both IMP and commercial supply chains * Deputize for VP, Quality when required Product Quality Management * Define and implement phase‑appropriate ways of working with external partners, ensuring alignment with Compass strategies and regulatory expectations * Manage all Quality aspects of commercial readiness activities, within Compass and across the extended supply chain * Drive strong, collaborative Quality relationships with CMOs, ensuring alignment with Compass QMS requirements and commercialization objectives * Build a robust and resilient supply chain while ensuring compliant, cost-effective processes that support profitable growth * Provide strategic Quality direction to support dual supply for clinical (IMP) supply and a fully commercial supply chain Candidate Profile: * Broad based knowledge of the pharmaceutical industry at least 12 years' experience in the industry of which 7 should be at a managerial level. * Scientific/engineering degree or equivalent combination of education and experience * Postgraduate qualification in Quality Management or equivalent combination of education and experience * A proven understanding of GMP, GCP, Pharmacovigilance and Quality Management requirements as applied in the industry * Excellent understanding of continuous improvement in a pharmaceutical environment * A passion for continuous improvement and experience applying techniques such as RCA root-cause analysis, CAPA, Lean, Six Sigma * Ability to identify appropriate KPI's, implement and use as control mechanisms and drive change and improvement * Extensive experience of establishing and leading the QMS system and process, in a highly regulated environment across multiple sites, GxPs and locations * Proven ability to present effectively to all levels of an organization to include project rationale and updates, strategic plans * Ability to build effective relationships (internal and external) * Excellent verbal and written communication skills, including the ability to interact effectively with different audiences * Excellent networker with the ability to collaborate and agree outcomes * Ability to understand quality issues in a complex a highly regulated environment and make data driven recommendation/decisions and take appropriate action * Proven record of leading management and staff to deliver business plans 【For NYC】Compensation Description (annually): 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】:$180,000—$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 Founded in 2009, EDETEK is a global leader in clinical technology and services, delivering high-quality, AI-powered platforms and solutions to pharmaceutical, biotechnology, and medical device companies. With a presence across four continents and a client base of over 100 biopharmaceutical companies, EDETEK is transforming clinical development through cloud-native technologies, intelligent data management, and automation. Our platforms are built for scalability, interoperability, and compliance. The Director of AI will lead the development and implementation of AI strategies to enhance clinical development processes. This role is responsible for architecting scalable AI solutions, guiding technical execution, and driving innovation across EDETEK’s AI product portfolio. The ideal candidate will have deep expertise in AI and clinical development for life sciences companies, with a strong background in machine learning, data science, and enterprise AI systems. This role requires a dynamic leader who thrives in a fast-paced, startup-like environment and can translate business goals into impactful AI solutions. Essential Functions and Responsibilities 1. AI Strategy & Leadership • Define and execute the AI vision aligned with EDETEK’s strategic goals., • Lead cross-functional teams to deliver AI-driven capabilities across clinical development., • Provide technical leadership and mentorship across the AI engineering team., • Inform and deliver on ambitious product roadmaps to accelerate growth. 2. AI Architecture & Development • Architect and build scalable AI infrastructure and solutions to support business growth., • Oversee model training, optimization, and deployment of end-to-end ML models., • Define best practices for AI/ML lifecycle management and governance., • Ensure compliance with industry standards and regulatory frameworks. 3. Collaboration & Stakeholder Engagement • Collaborate with stakeholders to translate business goals into technical solutions., • Partner with engineering, product, and clinical teams to integrate AI into platform capabilities., • Communicate AI strategy and progress to executive leadership and external partners. 4. Innovation & Technical Execution • Lead initiatives in advanced AI domains including transfer learning, generative models, and reinforcement learning., • Drive the development of enterprise knowledge management systems, NLP frameworks, and semantic data integration., • Master’s degree in Engineering, Computer Science, or a related quantitative field; advanced degree preferred., • 6+ years of hands-on experience in clinical trials and clinical development., • 3+ years of experience building and deploying AI/ML solutions and products., • Strong background in AI/ML fundamentals and software development., • Experience with modern databases, cloud environments, and data ecosystems., • Proven success in leading large-scale projects with multiple stakeholders., • Ability to thrive in a startup-mode environment and manage change effectively., • Excellent communication and interpersonal skills. Preferred Qualifications, • Expertise in transfer learning, unsupervised feature generation, meta-learning, generative text models, reinforcement learning, and Agentic AI., • Proficient in deep programming and production-grade AI implementation., • Experience designing enterprise knowledge systems, semantic web frameworks (RDF, OWL, SPARQL), and healthcare classification systems (SNOMED CT, CDISC, MeSH)., • Advanced data science and mathematical skills (e.g., PhD in computational modeling, machine learning, statistics, computer science). Why Join EDETEK?, • Opportunity to lead and innovate in a dynamic and growing company., • Collaborative and inclusive work environment., • Competitive salary and benefits package. Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees. • Choice of comprehensive Medical, Vision and Dental Insurance plans, • Paid vacation time and sick days, • Corporate holidays annually, • Participation in the 401K Plan, • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.

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 National Sales Director is a second-line sales leadership role responsible for building, developing, and leading a high-performing regional sales director team, supporting the launch and growth of an innovative mental health therapy. The National Sales Director will play a critical role in pre-launch planning, access strategy, field team buildout, and revenue growth, ensuring successful commercialization in a rapidly evolving regulatory and clinical landscape. The National Sales Director (East) will operate at the intersection of strategy and execution, ensuring alignment across Sales, Medical Affairs, Market Access, and Patient Support to enable safe, responsible, and effective delivery of therapy. Location: Remote, field-based in the US. Reports to: Vice President, Sales. Roles and responsibilities (Include but are not limited to): • Recruit, onboard, and lead a team of Regional Sales Directors, • Develop and execute the sales strategy for launch of the company's first innovative mental health therapy, • Partner with commercial operations to lead commercial readiness planning, including territory design, account targeting, and launch execution, • Establish sales targets, KPIs, and revenue goals aligned with company growth objectives, • Foster a high-accountability, psychologically safe culture that promotes coaching, development, and collaboration, • Set clear expectations and performance standards aligned with company launch objectives, • Drive successful national execution of the commercial launch strategy and identify opportunities to expand the treatment ecosystem., • Partner cross-functionally with Medical Affairs, Market Access, Training, Patient Support, etc., • Provide field insights to inform brand strategy and launch optimization, • Analyze national performance metrics to drive consistency in execution across regions, • Bachelor's degree required (advanced degree preferred), • 10–15+ years of pharmaceutical or biotech sales experience, • 8+ years of sales leadership experience at multiple levels, • Proven success leading national or multi-regional teams, • Launch experience in emerging or highly complex therapeutic categories, • Experience in psychiatry, CNS, or behavioral health markets, • Experience launching therapies requiring site certification, REMS, or specialized administration models and/or a background working with IDNs, academic medical centers, and specialty treatment sites 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】:$230,000—$280,000 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 Job Title: Program Director – Early Phase Clinical Research Job Description: The Program Director leads the operational and financial aspects of an early phase clinical research program at an NCI-designated cancer center, with a primary focus on training and onboarding new study coordinators, managing a complex clinical trials portfolio, and ensuring compliance with regulatory and billing requirements. This role works closely with a multidisciplinary research team to support patients enrolled on early phase therapeutic trials and serves as a key liaison with external sponsors and regulatory bodies. Responsibilities: • Train and onboard new study coordinators, ensuring they understand clinical trial protocols, regulatory requirements, and internal processes., • Work closely with program leaders, co-investigators, research coordinators, research nurses, data managers, and protocol office staff to manage each patient accrued to early phase studies., • Oversee billing compliance for early phase therapeutics trials, ensuring proper ordering and association of consults and ancillary services such as laboratory tests and imaging., • Review charges and designations after each visit is closed to ensure accurate and compliant billing practices., • Manage the clinical trials portfolio for early phase studies and drive timely start-up of protocols to meet NCI expectations of less than 90 days from activation requirements., • Review Medicare coverage analyses to confirm appropriate procedure-level designations and alignment with protocol and payer requirements., • Serve as the principal liaison for the early phase clinical research program with pharmaceutical and biotechnology companies, fostering collaborative sponsor relationships., • Prepare for and support NIH, BRANY, sponsor audits, and FDA inspections, ensuring documentation and processes meet regulatory standards., • Participate in departmental and institutional committees as needed, contributing operational and clinical research expertise., • Provide leadership, guidance, and oversight to the clinical research team, including CTMS staff, clinical research coordinators/data coordinators, nurse practitioners, and physician assistants., • Minimum of 5 years of related work experience in clinical research or clinical operations., • Prior clinical research experience in early phase drug development., • Strong knowledge of federal and local regulations governing clinical research., • Demonstrated experience in clinical operations, including management of clinical trials and study coordination., • Proven ability to onboard and train new staff effectively., • Ability to interpret and apply Medicare coverage analyses and procedure-level designations., • Experience with billing compliance processes in a clinical research setting., • Excellent communication and collaboration skills for working with multidisciplinary research teams and external sponsors., • Degree in Life Science or Public Health required., • ACRP or SOCRA certification obtained within 24 months of employment., • MD or DO (or foreign equivalent) degree preferred., • Familiarity with CITI training requirements for human subjects research., • Knowledge of IATA requirements related to clinical research activities., • Experience working in an NCI-designated cancer center or oncology research environment is highly desirable., • Ability to represent the clinical research program professionally in interactions with pharmaceutical and biotechnology partners. This is a Contract position based out of Bronx, NY. Pay and Benefits The pay range for this position is $65.00 - $65.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

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 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 seeking a Counsel, Contracts and Legal Affairs (Director level) to join our legal team and lead high impact contracting matters across R&D, commercial operations, market access and G&A functions as we prepare to launch our first commercial product. This is a hands-on role for an experienced in house attorney who enjoys ownership, cross functional partnership, and operating in a fast moving, scaling organization. Location: Hybrid in NYC/NJ. Reports to: VP, Associate General Counsel. Roles and responsibilities (Include but are not limited to): • Draft, review, and negotiation of complex R&D and clinical development agreements, including:, • Clinical trial agreements (CTAs), • CRO, CDMO, and other strategic vendor agreements, • Research collaboration and services agreements, • Draft, review, and negotiation of commercial contracting agreements, including:, • Commercial vendor and services agreements, • Supply, manufacturing, distribution, and logistics agreements, • Support negotiation of payer and market access agreements, including managed care, reimbursement, and innovative contracting models (where applicable), • Advise business partners on contractual risk, deal structure, and practical solutions aligned with company strategy, • Help build and scale contracting processes, templates, and negotiation playbooks, • JD from an accredited law school and active bar membership in at least one U.S. jurisdiction, • Typically 3-5+ years of legal experience, with meaningful in house experience in the pharmaceutical or biotechnology industry strongly preferred or relevant law firm experience supporting life sciences clients, with exposure to in-house-style responsibilities, • Significant experience negotiating:, • R&D and clinical development contracts, • Commercial vendor and operational agreements, • Payer or market access–related agreements, • Other vendor agreements, • Strong understanding of the legal and compliance considerations facing emerging commercial-stage life sciences companies, • Proven ability to lead matters independently and exercise sound judgment, • Business oriented mindset with excellent communication and stakeholder management skills, • The ideal candidate should have the following characteristics:, • Legal smarts, analytic rigor, business sense, and a strong work ethic;, • Ability to operate independently and work cross functionally with various teams across the organization;, • Excellent interpersonal communication skills and exemplary attention to detail;, • Likes finding solutions to complex problems and works well under pressure;, • Strong written and oral communication (including analysis, interpretation, & reasoning) and organizational skills (project management);, • Flexible, with excellent ability to manage multiple projects simultaneously; and, • Experience supporting a clinical to commercial transition or first product launch, • Exposure to market access, reimbursement, or payer contracting strategy, • Play a leadership role at a company approaching a major commercialization milestone, • Work closely with senior stakeholders across development and commercial team 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】:$200,000—$260,000 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 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%

Description Overview: You provide the vision, set the pace and inspire success. There's one thing you do that's exceptional: lead. You formulate a plan and focus your team to solve the unsolvable, beat the unbeatable and come out on top. Your capacity to creatively strategize, motivate sales professionals, and elicit achievement makes you the right fit for a Regional Sales Manager role with Syneos Health. Responsibilities: This opportunity is with our Deployment Solutions Commercial Division, which partners with top-tier pharmaceutical, medical device and biotechnology companies to develop and execute sales and marketing strategies that deliver. The Regional Sales Director will report to the Syneos Health National Business Director and will be directly responsible to hire, train and develop, as well as coach the sales team in their district in order to successfully promote product targeted physicians. You will: • Be responsible for motivating, managing and developing the skill sets and overall performance of the sales representatives in their district, • Effectively identify and monitor multiple local market conditions to build and support strong customer relationships while driving product promotion solutions and executing marketing strategies, • Monitor field activities to ensure all are within compliance guidelines and provide timely feedback on marketing tactics and market conditions while collaborating closely with leadership, commercial operations, marketing and medical affairs, • Compliantly driving sales objectives to meet & exceed corporate forecast Along with a results-oriented mindset, self-assurance and an engaging manner, the ideal candidate has: • Bachelors Degree - Advanced Degree Preferred, • 7+ Years of Pharmaceutical / Healthcare industry experience, • Experience in the Oncology marketplace required, • 2+ Years of regional Oncology field management experience, • Excellent organizational skills, especially in project planning, project implementation, and cross-functional team management, • Ability to hire, lead, coach & mentor high performing teams Interviews may be conducted in person at an on-site interview location. For any in person interviews, local COVID-19 safety guidelines will be followed. At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our ___ to stay connected to additional career opportunities. Why Syneos Health? Here, the work is challenging, and the pace is exhilarating. By joining one of our commercial teams, you're empowered to succeed with the support, resources, and autonomy that you need. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Syneos Health has launched more sales teams in the last 5 years across all major therapeutic areas than the top 25 pharma companies combined. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world. Work Here Matters Everywhere | How are you inspired to change lives? Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled) Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements. 400004670

• Job Type: Officer of Administration, • Bargaining Unit:, • Regular/Temporary: Regular, • End Date if Temporary:, • Hours Per Week: 35, • Standard Work Schedule:, • Building: The Executive Director of Translational Strategy and Innovation will lead a diverse portfolio of early-stage biomedical and healthcare innovation projects at the Vagelos College of Physicians and Surgeons (VP&S), advancing discoveries from bench-to-bedside. The Executive Director will provide strategic, scientific, and operational leadership to accelerate these translational projects, ensuring timely achievement of project milestones, effective resource allocation and alignment with institutional priorities. The director will work closely with the VP&S research leadership and an advisory council of executives with leadership experience in biotech, venture capital and at major pharmaceutical companies. A key focus of this role is developing and executing multi-year business plans, piloting innovations across the healthcare ecosystem, and cultivating partnerships with investors, venture capital firms, private equity, biotech and medtech companies, incubators, and other funding agencies to support commercialization and innovation success. This role will bridge the medical school and industry, integrating insights from market and investment landscapes across biotech/pharma, medtech, digital health/AI, and diagnostics to support strategic decision-making and innovation success. Working collaboratively across the VP&S research and clinical enterprise, the director will design frameworks that promote innovation, translation and impact in therapeutics. The ideal candidate will have experience working at or with pharmaceutical, biotechnology, or life science organizations and will demonstrate the ability to work across various scientific modalities, including cell and gene therapies, small and large molecules, and antibody-based therapeutics. Responsibilities • Strategic Leadership: Oversee a broad portfolio of early-stage translational projects, guiding teams from research and development through to clinical and commercial translation ("bench to bedside")., • Scientific Integration: Apply a deep understanding of translational and preclinical science to align research initiatives with downstream development needs., • Team Development: Build and lead a high-performing team of project managers and staff; oversee hiring, career development, performance management, and team structure to ensure effective project execution, timely milestone achievement, and overall program success., • Program Planning: Develop and implement multi-year business plans, including pilot implementations within the healthcare ecosystem. Establish metrics, timelines, and feedback cycles to monitor progress, ensure accountability, and drive continuous improvement., • Market Analysis: Conduct market, scientific, regulatory and clinical opportunity assessments to inform strategic decision-making and investment readiness., • Partnership Development: Lead high-level negotiations, communications, and presentations across diverse stakeholder groups, including academic researchers, corporate partners, investors, and industry collaborators. Effectively bridge cultural and organizational differences to build consensus, foster partnerships, and advance project goals., • Institutional Alignment: Advise senior leadership on the long-term program strategy. Evaluate organizational structure and effectiveness to drive continuous improvement in processes, team performance, and impact., • Cross-Campus Collaboration: Coordinate with key partners, including Columbia Business School, Columbia Doctors, New York-Presbyterian, Columbia Technology Ventures (CTV), Columbia Development, and external industry collaborators. Other Requirements • Ph.D., M.D./Ph.D., or equivalent advanced degree in a relevant scientific or biomedical discipline, or MBA with significant life science experience., • 10 plus years of experience in the healthcare technology, life sciences, or venture/startup ecosystem, • Demonstrated success leading early-stage ventures, including business development, fundraising, and strategic partnership execution., • Strong understanding of innovation and development in therapeutics (biotech/pharma), medtech, or digital health., • Proven ability to manage complex, multi-stakeholder projects in a high-growth or research-driven environment., • Exceptional analytical and quantitative skills; proficiency with project management and productivity tools., • Excellent communication and interpersonal skills, with the ability to engage effectively with senior executives, faculty, and industry partners., • Deep understanding of the end-to-end development process from discovery through clinical development and commercialization., • "Hands-on" leadership style-strategic yet comfortable working tactically to drive progress., • Demonstrated leadership, planning, and organizational change management skills., • Advanced financial expertise in budget planning and forecasting., • Strong analytical, problem-solving, and decision-making abilities., • Knowledge of industry standards, regulatory frameworks, and compliance requirements. Columbia University is committed to the hiring of qualified local residents.

Position Summary The Califano lab, in the Department of Systems Biology at Columbia University, is seeking exceptionally qualified candidates for a Postdoctoral Research Scientist position in the laboratory. Successful candidates will possess extensive expertise in wet-lab experimentation and advanced single-cell and spatial multi-omics technologies and will participate in highly competitive research programs aimed at producing innovative, high-impact publications. The ideal candidate will have outstanding scientific credentials, including first-author publications in leading journals and presentations at major international conferences relevant to single-cell biology, spatial genomics, systems immunology, cancer biology, stem cell biology, or related fields. We are particularly interested in candidates with demonstrated expertise in the development and application of spatially resolved and single-cell technologies, including spatial transcriptomics, spatial ATAC-seq, multiplexed spatial proteomics, CITE-seq, Perturb-seq, CROP-seq, CRISPR-based perturbation systems, and advanced single-cell library preparation and profiling methods. Candidates with strong backgrounds in immunology, cancer biology, stem cell biology, molecular and cellular biology, epigenetics, genetics, biomedical engineering, biochemistry, or related disciplines will be especially well suited. Experience integrating multimodal datasets-including transcriptomic, epigenomic and proteomic modalities-to define regulatory programs and cellular states within intact tissue architecture is highly desirable. Integration of quantitative analysis, high-throughput experimentation, and technology development is a hallmark of our department and laboratory. Accordingly, the Postdoctoral Research Scientist will: • Develop and apply cutting-edge spatial and single-cell multi-omics technologies to interrogate regulatory and signaling networks in complex tissue ecosystems., • Define cell-state transitions and regulatory circuits in physiologic and pathophysiologic contexts with current focus on cancer., • Design and implement CRISPR-based perturbation strategies (CRISPR, CRISPRi/a) to functionally test regulatory hypotheses derived from systems-level inference., • Integrate genomic, epigenomic, and proteomic datasets to elucidate molecular determinants of cellular phenotypes and their spatial organization., • Develop new methodological and computationally informed frameworks for dissecting regulatory logic and signaling network architecture within tissues. The successful candidate will be expected to thrive in a highly collegial and collaborative environment, mentor junior trainees, contribute to consortium-scale and multi-institutional projects, and participate in the preparation of fellowship and grant applications. Strong communication and scientific writing skills are essential. Our laboratory has an outstanding record of training and career placement, with former members advancing to academic faculty positions (including leadership roles) and senior positions in biotechnology and pharmaceutical industries. Minimum Qualifications • PhD in molecular biology, immunology, cancer biology, genetics, epigenetics, stem cell biology, biomedical engineering, biochemistry, or a related field., • Demonstrated record of first-author publications in peer-reviewed journals., • Expertise in spatial transcriptomics, spatial ATAC-seq, multiplexed proteomic imaging, and multimodal data integration., • Experience with CRISPR-mediated gene editing, perturbation screening (including single-cell CRISPR-based approaches), and gene regulatory analysis., • Familiarity with regulatory and signaling network modeling and systems biology frameworks., • Experience working with complex in vivo models and/or primary human tissues. Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with our customers, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and ambitions with. In the USA, we develop, market and produce a wide array of solutions from our 25 most innovative sites, based across the country. Stretch your skills, create and get inspiration from passionate colleagues. Every day, your energy, your thirst for knowledge, and your creativity will shape our future, making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human by nature. The Active Beauty (Cosmetic ingredients) Senior Account Manager manages assigned accounts to achieve revenue, gross profit, and growth targets. You will manage account planning, forecasting, pricing, and execution of customer projects from brief through production and launch. You will coordinate teams and maintain relationships with customer team members to support our goals. Job TitleSenior Account Manager - Active Beauty Location New York City, NY Reporting To Head of Sales - Active Beauty, NOAM Responsibilities Account Management and Customer Engagement * Manage assigned accounts to meet revenue, gross profit, and growth targets * Maintain relationships with customer decision-makers, influencers, and partners * Develop understanding of customer strategies, positioning, strengths, weaknesses, and competition * Ensure participation in core listings and targeted customer briefs * Identify and pursue new business opportunities and support retention of existing business * Promote value propositions, including the latest Active and Specialties Ingredients, with a scientific biology angle. * Monitor competitor activity and market conditions * Manage customer submissions, follow-ups, and transition of projects to production and launch * Manage customer issues and track resolution status * Support Customer Care in supply chain coordination and Credit Management in receivables collection Business Planning and Commercial Execution * Develop, review, and build Account and Category Plans, including forecasts and budgets * Apply strategic planning, budgeting, and forecasting processes to support account performance * Monitor Goals (sales, gross profit, win rate) and take corrective actions when targets are not met * Lead pricing discussions according to company guidelines and ensure implementation of agreements * Apply cost-to-serve considerations to support profitability and resource allocation * Understand profitability drivers, including raw material cost impact * Manage financial aspects of accounts, including forecasting and pricing models * Support implementation of pricing agreements and commercial terms Leadership and Project Execution * Coordinate teams (R&D, Marketing, Consumer Research, Applications) * Present account plans and project updates to company partners * Lead brief handling processes and ensure completion of required functional steps * Coordinate internal resources to support efficient delivery of customer solutions * Deliver presentations to all partners * Work with international teams to support account goals * Follow company policies and regulatory and EHS requirements Your Professional Profile Includes * Bachelor's degree or equivalent experience, a scientific background in biology, biochemistry, biotechnology preferred, an MBA is preferred * 10+ years of professional experience * 6+ years of experience in a related industry or functional role * Experience managing customer accounts * Experience coordinating teams * Experience with pricing discussions and contract terms * Experience with forecasting, budgeting, and financial tracking * Present information to all partners * English proficiency (written and verbal) * Knowledge of market dynamics, customer strategies, and competitor activity * Industry knowledge relevant to product, applications, or technical processes Compensation and Benefits The established salary range for this position is $155,000-$185,000. Actual compensation will depend on individual qualifications. Medical, dental, and vision coverage and a high-matching 401(k) retirement plan. #LI-Onsite At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives. You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions. Every essence of you enriches our world. Diversity of perspectives fuels innovation and fosters deeper connections with our employees, customers, and partners. At Givaudan, we are dedicated to cultivating an inclusive environment where every individual's voice is valued and has the power to shape our world. Join us in making a difference together.

Job Summary Looking for a role that challenges you while making an impact on products people use every day? IFF is a global leader in flavors, fragrances, food ingredients, and health & biosciences. We partner with customers around the world to deliver sustainable, sciencebased innovations that elevate everyday products. Health & Biosciences:Channeling our passion for nature and bioscience into sustainable, life-enhancing technologiesthat powerinnovative solutions across healthcare, food, consumer and industrial markets. This role is based in United State and is a remote position. You will be part of a collaborative, technically rigorous, and customerfocused team where deep expertise and strong partnerships drive meaningful impact. At IFF, your potential is our inspiration. • Provide specialized technical and scientific support for enzyme and yeast applications in customer environments, • Collaborate with sales teams during customer meetings, trainings, and onsite visits, • Serve as an internal technical expert on assigned product lines, applications, and limitations, • Conduct routine plant visits to perform process audits, lab analysis, and performance optimization, • Analyze process and laboratory data to identify improvement opportunities and make recommendations, • Develop tools or models to enhance data analysis and technical decisionmaking, • Deliver customer training on product selection, application, and optimization, • Provide postsale technical troubleshooting during product testing and implementation, • Support account planning and identify business development opportunities from a technical and commercial perspective, • Bachelor's or Master's degree in a scientific or technical discipline (Biology, Microbiology, Chemistry, Engineering, or related), • 3-4 years of experience in an industrial biotechnology environment (enzymes, food, fuel alcohol, or similar), • Strong analytical and problemsolving skills with the ability to interpret technical data, • Proficiency with Microsoft Office; experience with JMP or other statistical software preferred, • Customerfocused mindset with strong relationshipbuilding skills, • Selfmotivated and resultsoriented, able to work independently, • Strong organizational skills and ability to prioritize in a dynamic environment, • Ability to collaborate effectively across Sales, Marketing, and R&D, • Willingness to travel 50% or more, • Handson experience supporting fermentation or enzymedriven industrial processes, • Prior success in a customerfacing technical or application support role, • Ability to translate complex technical insights into clear, actionable customer recommendations Why Choose Us? • Training opportunities, • Learning and development programs from day one, • Our benefit package includes medical, dental, vision, 401k, vacation, holidays, 16 weeks paid parental leave (maternity and paternity) and an annual bonus plan. We are a global leader in taste, scent, and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability. Visit ___ to learn more

The successful candidate will drive the design and execution of innovative marketing campaigns. The role demands at least 5 years of marketing experience, with a focus on strategy and execution, particularly within the biomedical/biotechnology sectors. Jobgether is seeking a Marketing Campaigns Mana

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Performs statistical analysis on data related to product development in a research and development environment. Uses statistical software such as SAS, SPSS, and other software to create and maintain listings, tabulations, graphical summaries, and formal statistical estimates and tests. Creates analysis datasets, assesses quality of data analysis programs, and develops automated analysis tools where appropriate. May be responsible for data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies. May partner with biostatisticians, clinicians, medical services and clinical data management staff in establishing standards for clinical data collection, management and/or reporting of data. Associate Director, Statistical Programming sought by Eisai Inc. in Nutley, NJ. Spearhead the statistical programming activities for multiple studies and lead the programming submission related activities. Work with the Head of programming to establish standards for programming and establish efficiency within the group. Serve as the key "go to" Subject Matter Expert for all Statistical Programming issues. Drive the success of key projects and deliverables. Significant areas of oversight include SAS programming activities in support of Multiple Studies (Phase II -IIIB) for a single or multiple compounds within related therapeutic areas spanning inception through to submission. Requirements: A Master's degree in Molecular and Cellular Biology, Biotechnology, or closely related plus 8 years of experience in Pharmaceutical industry experience in clinical development statistical programming methods and processes in job offered or related roles. Also requires 4 years' experience with/using the following (which may have been gained concurrently): * CDISC expertise (SDTM and ADaM). * NDA/BLA submissions, ISS/ISE and eSub requirements. * Regulatory & Compliance Requirements for Biostatistics processes. * Management of CRO vendors within a matrixed environment. * Alzheimer Disease and Neurology research study experience * SAS EG The base salary range for the Associate Director, Statistical Programming is from $200,091.38 - $217,900.00. Under current guidelines, this position is eligible to participate in: Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Employees are eligible to participate in Company employee benet programs. Please send resumes to HR Department, Job Code: (list Job code #R4048) Eisai, Inc., 200 Metro Blvd, Nutley NJ 07110. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

New York, New York, United States of America.TD is committed to providing fair and equitable compensation opportunities to all colleagues.Growth opportunities and skill development are defining features of the colleague experience at TD.Our compensation policies and practices have been designed to a

New York, New York, United States of America.TD is committed to providing fair and equitable compensation opportunities to all colleagues.Growth opportunities and skill development are defining features of the colleague experience at TD.Our compensation policies and practices have been designed to a

A biotechnology company in New York is seeking a Senior Director of DBS Growth to lead the marketing and product management strategies focusing on life sciences and diagnostics.

Accounting and Administrative Support.My client is a growing biotechnology company dedicated to developing cutting-edge solutions rooted in scientific research.The company supports complex operations across research, development, and clinical activities.Manage incoming mail, including sorting, scann

Global Portfolio Leader - Small Molecule Modeling Schrödinger seeks a Global Portfolio Leader to join us in our mission to improve human health and quality of life through the development, distribution, and application of advanced computational methods. As a leader on our Sales team, you will be the primary strategic architect for our small molecule modeling software Portfolio, ensuring that the Portfolio drives value across global pharmaceutical and biotechnology pipelines. This role involves partnering with R&D leadership to embed our software into their scientific workflows, demonstrating the value of running the Schrödinger Platform at scale. You'll be a bridge between our customers' scientific goals and Schrödinger's internal product and drug discovery teams. Who will love this job: • An experienced account manager with a proven track record of managing across diverse regions and time zones, • A leader who's excited to steward the health, growth, and strategic alignment of Schrödinger's top-tier global accounts, • A scientific thinker who understands the drug discovery process (hit-to-lead through clinical trials) and the role of molecular modeling, • Design and implement comprehensive Go-to-Market (GTM) strategies for new software modules and platform updates within your portfolio; collaborate with Marketing and Product teams to define value propositions, identify high-potential user segments, and create roadmaps for successful product integration across global R&D sites, • Serve as the primary point of contact for executive stakeholders across a global portfolio; develop and execute multi-year account strategies that align our computational capabilities with clients' therapeutic areas, • Identify opportunities for the expansion of the assigned product portfolio; work closely with Scientific Lead teams to ensure high-impact software adoption, • Manage the full lifecycle of global renewals and expansions; ensure a predictable revenue stream by maintaining high satisfaction levels and demonstrating clear ROI on computational spend, • Orchestrate internal resources, including Account Managers, Education Specialists, and Application Scientists, to deliver a unified and elite experience for global accounts, • At least seven years of account management, strategic consulting, or business development experience in the life science or SaaS sectors Schrödinger understands it's people that make a company great. Because of this, we're prepared to offer a competitive salary, equity-based compensation, and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, a flexible work schedule, and a parental leave program. We have a company culture that is relaxed, engaged, and over a month of paid vacation time. Our Administrative and Human Resources departments also plan a myriad of fun company-wide events. New York is home to our largest office, but we have teams all over the world. Schrödinger is honored to have been selected as one of Crain's New York Best Places to Work from 2018 to 2023. Estimated base salary range: $190,000 - $250,000. Actual compensation package is dependent on a number of factors, including, for example, experience, education, degrees held, market data, and business needs. If you have any questions regarding the compensation for this role, do not hesitate to reach out to a member of our Strategic Growth team.

About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: • Our Vision for AI in Pharma, • Our Current Drug Portfolio, • Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position The Associate Director, Drug Substance, Biologics, will provide technical, strategic and hands-on operational leadership for all CMC activities related to drug substance development and manufacturing, with a primary focus on Biologics at all stages of development (IND-enabling to commercialization). The Associate Director, Drug Substance, will be responsible for overseeing the process development, manufacturing and release of drug substances at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug substance manufacturing (either cell culture or downstream purification), strong technical problem-solving abilities, and proven experience managing complex manufacturing operations with external partners. You will play a critical role in accelerating our mission of bringing new treatments to patients faster and more efficiently. Responsibilities Development and Manufacturing Strategy, Operations and Oversight * • Lead drug substance manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints., • Serve as the primary technical interface with CDMOs for drug substance manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing network., • Oversee cell culture and downstream purification activities related to process development and manufacturing for both microbial and mammalian expression systems. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements., • Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues, • Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities., • Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug substance for clinical trials and commercial supply., • Lead technical assessments and qualification of new CDMOs for drug substance manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional), • Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation., • Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions., • Partner closely with Drug Product Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Program Management leads to ensure seamless integration of manufacturing activities into overall program execution., • Collaborate with procurement to ensure timely contracting for drug substance manufacturing. About You, • MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline., • 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug substance manufacturing (either cell culture or downstream purification), • Demonstrated track record of successfully managing drug substance manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing., • Technical expertise in either cell culture or downstream purification for process development, manufacturing, process characterization and process validation for biologics. Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.

Investment Banking Associate Healthcare Services and Technology. Jefferies Global Healthcare Group provides comprehensive advisory and capital markets services across healthcare services, biotechnology, pharmaceuticals, medical technology, tools and diagnostics, and healthcare technology. We are see

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology? At Pall Corporation, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.You’ll t

This position supports a busy intellectual property practice focused on biotechnology and life sciences innovations. The role involves working closely with patent attorneys on patent prosecution, counseling, and related matters while assisting clients in protecting and developing their intellectual

The successful candidate will assist a team that provides counsel regarding technology acquisition, development and divestiture, technology licensing, outsourcing, IT services contracts, and related transactions for the high-technology, insurance, finance, energy, media and gaming, biotechnology, ph

Counsel, Contracts and Legal Affairs.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

The ideal candidate will have experience in life sciences related patent and IP work including counseling and due diligence, patent preparation and prosecution, and drafting and negotiating IP agreements.A graduate degree in molecular biology, immunology, biochemistry, or a related area is required,

Equity Research Associate - Biotechnology, Jefferies, New York, NY.

We are looking for a Biotechnology R&D Scientist to join our team to train AI models.

Top investment bank is seeking an equity research associate to support senior biotechnology analyst covering mid- and small-cap companies out of our New York or San Francisco offices.Responsibilities will include:.Conducting proprietary research evaluating biotech companies' therapeutic pipeline by

Wolfe Research was voted #6 on a weighted basis for equity research during 2025 by institutional clients in the prestigious Extel's All American Research Poll, trailing only significantly larger bulge bracket firms, who have historically not been viewed as our peers. Our firm covers publicly traded