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Inizio Engage has partnered with Boehringer Ingelheim to deliver impactful clinical education and support for Healthcare Professionals across primary care settings. We are seeking experienced, credentialed, educators for Obesity/Liver Disease on behalf of Boehringer Ingelheim who are passionate about metabolic health and driven to improve understanding of obesity and liver disease through high-quality disease-state education. This is your opportunity to join Inizio Engage and represent a top biotechnology company! What's in it for you? • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) What will you be doing? As a Metabolic Educator, you will serve as a field-based clinical expert responsible for delivering evidence-based disease-state education in obesity and liver disease to Healthcare Professionals and office staff across your assigned territory. You will: • To provide disease state-related educational support, awareness, and resources to identified Healthcare Professionals and to office staff as agreed with the client and Inizio Engage., • To present educational programs, both live and virtual, to Healthcare Professionals in accordance with the needs of each office., • To foster awareness of speaker sessions to HCPs through client’s speaker bureau., • Provide support at client convention booths., • Collaborate effectively with cross-functional and matrix partners to align on strategy, share insights, and drive cohesive execution of organizational goals., • To only use or distribute approved materials provided by the client, without changing, or copying the materials., • To attend and complete all training courses and related competency assessments that Inizio Engage and client requires, to an appropriate standard and within a specified timeframe., • Develop and strengthen relationships with appropriate customers and other matrix partners., • To facilitate the development and provision of education and educational materials across specified accounts, as determined by the client and Inizio Engage., • Complete all required administrative responsibilities in a timely manner. Some of these could include but are not limited to: daily computer updates, weekly summary of activity reports, emails and monthly expense reports., • Maintain professional registration and/or licensing as required by applicable state laws., • Attend local and other meetings, as required, to keep abreast of plans, activities and developments and to exchange knowledge and experience within the team., • Maintain all company equipment and materials in accordance with company instructions., • Comply with all Inizio Engage Policies and Procedures, along with all Client Policies and Procedures as required., • Be contactable during working hours to answer queries., • To possess a full valid US driver’s license at all times and to notify the company immediately of any offences or accumulation of penalty points., • Perform other duties as requested. What do you need for this position? • Registered Nurse (BSN required), Registered Dietitian (Bachelor's in Nutrition required), Advanced Practice Registered Nurse, or Physician Assistant with 3+ years of post-education clinical experience, • Active U.S. healthcare license in area of training, • Experience in metabolic health required, • Preferred certifications:, • Certified Obesity Educator, • Certificate of Advanced Education in Obesity Medicine, • Certified Diabetes Educator, • Demonstrate effective and professional communication, • Ability to present to various groups of people including physicians and other members of the office staff, • The jobholder may be required to do up to 20% overnight travel. Occasional weekends may be required., • Jobholder may be required to obtain specific disease state certification in obesity and metabolic disorders within first year of employment., • Valid U.S. driver's license About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

Inizio Engage has a long-standing partnership with a leading biotechnology organization across Commercial, Patient Solutions and Medical Affairs businesses. We are seeking a Regional Manager to lead and manage a designated team of field-based Clinical Educators supporting Healthcare Professionals within a specialized disease state. This leadership role is responsible for operational execution, performance management, compliance oversight, and ensuring key performance indicators are achieved across the assigned region. This is your opportunity to join Inizio Engage and represent a top biotechnology organization while leading a high-performing field team. What’s in it for you? • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) What will you be doing? • Manage the day-to-day operations of a designated team of Clinical Educators, • Demonstrate sound decision-making and judgment across operational, compliance, and people leadership responsibilities, • Ensure all program Key Performance Indicators (KPIs) are met or exceeded within assigned region, • Provide ongoing assessment of regional performance utilizing quantitative and qualitative data, • Support operational execution of all contractual program requirements, • Maintain working knowledge of program technologies including CRM systems, dashboards, and reporting tools, • Prepare, review, and validate regional reports, spreadsheets, and communications prior to distribution, • Conduct regular field visits with Clinical Educators, including documented coaching and Field Coaching Reports, • Provide ongoing coaching, performance management, and professional development to direct reports, • Communicate program updates, enhancements, and organizational initiatives clearly and effectively, • Ensure direct reports are equipped with appropriate tools, technology, and resources, • Partner with leadership to support client and internal meetings, offering solutions and insights, • Monitor roster changes including launches, realignments, territory changes, and other operational adjustments, • Support leadership coverage as needed during planned or unplanned absences, • Utilize financial and operational data to guide decision-making and control costs, • Travel within assigned region as required, • Perform other duties as requested What do you need for this position? • Bachelor’s Degree or equivalent work-related experience (BSN preferred), • Active RN or RT license required, • 2–3 years of field leadership or supervisory management experience, • Experience hiring, training, coaching, and developing talent, • Clinical education experience supporting Healthcare Professionals preferred, • Experience within a specified disease state or specialty area preferred, • Advanced communication and interpersonal skills, • Strong organizational and analytical skills, • Ability to interpret and leverage performance and financial data, • Must reside within 60 minutes of a major airport, • Valid U.S. driver’s license, • Proficiency in Excel, Word, and Outlook, • Willingness to travel up to 75% within assigned region, • Ability to lift and carry up to 25 pounds and operate standard office equipment About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

Job Description Nurse Practitioner Montclair, NJ, USA Job Description Job Summary: Working interdependently with physicians, nurses, and other healthcare providers, provides a broad range of nurse practitioner services following established policies and protocols. Essential Functions and Responsibilities: • Provides services to patients including but not limited to ambulatory care, taking health histories, risk assessment and cancer screening, performing assessments, diagnosis, and conducting health education and counseling., • Assess, manage and treat acute, chronic, benign, and malignant breast conditions. Performs assessment/data collection in an ongoing and systematic manner, focusing on physiologic, psychological, and cognitive status., • Interpret breast imagery (ultrasound, mammogram, MRI) collaboratively with breast radiologist., • Interpret breast pathology collaboratively with breast surgeon., • Perform genetic testing based on NCCN guidelines, interpreting common testing results, and conducting counseling based on results., • Develops plans of care based on patient assessment ensuring appropriate follow-up in accordance with established nurse practitioner protocols., • Provides teaching and emotional support to patients and families., • Refers patients for further care based on severity of illness and symptoms/response to treatments tried., • Utilizes written guidelines/protocol for clinical decision making and management., • Prescribes medication appropriate to breast care management. Will need current DEA and CDS licensure., • Routine office-based procedures: venipuncture, IV insertion, punch biopsies, post-operative care, suture removal and wound care., • Prepares timely, legible, and complete documentation of all patient care as provided by law, regulation, and established policy, • Demonstrates an awareness of and sensitivity to patient/family rights., • Applies safety principles as identified by established policy., • Participates in continuing education to continually improve skills and abilities and stay abreast of current technologies/practices., • Ensures compliance with legal issues including but not limited to patient confidentiality and risk management; federal, state, and local regulations., • Participates in quality improvement and utilization review activities., • Exhibits a high degree of courtesy, tact and poise when interacting with office staff, patients, families, and other healthcare professionals., • Adjusts to fluctuating peaks in patient flow, acuity, and other operational demands while maintaining quality., • Performs other related duties as assigned by management. Qualifications: • Ability to understand and adhere to established policies, procedures, and protocols., • Demonstrated competence in reacting to and handling emergencies., • Able to work collaboratively with multiple health professionals in a busy and complex environment using tact, diplomacy and discipline., • Strong charting/documentation skills., • Commitment to excellence and high standards, • Excellent written and oral communication skills, • Strong organizational, problem-solving and analytical skills, • Ability to manage priorities and workflow, • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm, • Acute attention to detail, • Ability to work independently and as a member of various teams and committees, • Strong interpersonal skills., • Ability to effectively communicate with people at all levels and from various backgrounds., • Good judgement with the ability to make timely and sound decisions, • Creative, flexible, and innovative team player Competencies: • Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Design’s workflows and procedures., • Problem Solving--Identifies and resolves problems in a timely and creative manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics., • Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things., • Communication--Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Documents clearly and thoroughly., • Teamwork--Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Asks for and offers help when needed., • Leadership--Exhibit’s confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others. Makes self-available to staff., • Quality--Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness. Time management, displays passion and optimism, strives to increase productivity, and generates suggestions to improve workflow., • Adaptability--Adapts to changes in the work environment; Manages competing demands; Change’s approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Physical Demands and Work Environment: • Frequently required to stand, • Frequently required to walk, • Frequently required to sit, • Continually required to utilize hand and finger dexterity, • Frequently required to balance, bend, stoop, or kneel, • Continually required to talk or hear, • Continually utilize visual acuity to operate equipment, read technical information and use a keyboard, • Occasionally required to lift/push/carry items up to 25 pounds, • Occasionally exposure to bloodborne and airborne pathogens or infectious materials Education and Experience: • MA/MS, • Completion of an accredited nurse practitioner program, • Graduate from an accredited school., • Current NJ state NP license and CPR certification., • DEA licensure in NJ., • CDS licensure in NJ., • Competitive Salary, • Medical, Dental & Vision Insurance, • Short and Long Term Disability, • Life Insurance, • Dependent Care Flex Spending Account, • Voluntary Policies (Accident, Hospital Indemnity, Critical Illness & Supplemental STD), • Legal Plan & Identity Theft Protection, • 401(k) Plan, • Paid Vacation & Holiday, • Business Casual Environment, • Credit Union Visit us at Montclair Breast Center, member of Genesis Global Group is an equal opportunity employer. Company DescriptionGenesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.Genesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.

Job DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (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 team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • 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, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.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.

About the Company: Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. POSITION SUMMARY The Contractor will provide operational and analytical support for commercial contracts, pricing execution, and logistics operations under the guidance of the Sr. Director, Pricing and Contracting. This role focuses on enhancing team operational efficiency through accurate data processing and meticulous execution of tactical tasks. KEY ROLES AND RESPONSIBILITIES Support the drafting and administrative review of commercial contracts, including organizing supporting exhibits and pricing addendums. Conduct primary data validation using Excel functions to flag outliers or calculation errors before final settlement. Manage and improve Excel-based tracking tools to streamline data consolidation and enhance reporting accuracy. Liaise with relevant departments (Finance, Sales, Supply Chain, etc) to gather necessary data for urgent pricing or logistics inquiries. WORK EXPERIENCE • 1–3 years of experience in Pharma/Biotech or related fields (Sales Support, Finance, Logistics)., • Experience in data-heavy administrative tasks and contract support. QUALIFICATIONS • Advanced Excel Skills (Required): Proficiency in VLOOKUP, Pivot Tables, and data organization., • Meticulousness: Strong attention to detail in data entry and document review., • Communication: Ability to clearly understand requests and coordinate effectively with relevant departments., • Bilingual, Korean preferred. EDUCATION • Bachelor’s Degree required in business or related field; advanced degrees, MBA, MS in business or related field is a plus. CORE COMPETENCIES • Analytical Rigor: Ability to process and validate large datasets with high accuracy using advanced Excel skills., • Operational Excellence: Strong attention to detail in managing contract documentation and meeting strict deadlines., • Collaborative Mindset: Effective communication skills to coordinate seamlessly with Finance, Sales, and Logistics teams., • Adaptability: A flexible approach to supporting diverse tactical tasks within a fast-paced commercial environment. Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-DD

Safety Partners is an Environmental Health & Safety (EHS) consulting company specializing in supporting life science and biotech companies. As an EHS Officer, you will have the continual opportunity to create, implement, and maintain EHS, programs for our growing list of life science and high-tech clients. Most of your time will be spent with clients at their locations in New Jersey and New York, developing and implementing customized programs in hazard communication, biosafety, chemical safety, emergency preparedness, radiation safety, and facilities safety. You will have a significant opportunity to interact with visionaries, researchers, and senior management at leading firms in fast-paced, highly varied environments. Being comfortable working with all different types of people in different corporate cultures is essential! We take pride in our staff having a strong science background. Being able to speak peer-to-peer is critical to our clients. As former scientists with a continual passion for learning our consultants understand what EHS policies and procedures can mean to experiments, timelines, and new products and procedures. If you are self-motivated, adaptable, willing to constantly learn, and want to be an “expert generalist” in EHS for life sciences, come join us! Job Responsibilities • Hands-on development and implementation of client EHS programs, including Biosafety, Chemical Safety, Radiation Safety, Hazard Communication, Emergency Preparedness, and Additional OSHA-specific safety programs as needed., • Establishment and maintenance of EHS permits and licenses in compliance with Federal, State, and Local regulations., • Conduct Job Safety Analyses for hazardous materials processes., • Conduct Risk Assessments to analyze and evaluate the proper handling of biological materials., • Work with client staff to bring about a high-level match of EHS culture and worker safety activities to written policies, procedures, instructions, and manuals., • Coordinate and facilitate safety committees., • Prepare and deliver training to fulfill regulatory requirements and ensure client employees are fully aware of the safety program., • Coordinate specialized training, such as RCRA, DOT, IATA, OSHA HAZWOPER, Wastewater Operator, CPR, First Aid, and AED., • Maintain complete documentation of all aspects of the EHS program. Qualifications • Bachelor's degree in Life Sciences; Biology or Chemistry degrees strongly preferred., • Master’s degree or PhD in Life Sciences preferred., • 3+ years of experience in a laboratory setting (biotechnology, pharmaceutical research, academic science, or medical technology science preferred) or EHS-related work experience. Required Skills and Competencies • Strong professional communication and written skills., • Able to positively interact both internally among the client staff and externally with regulatory agencies., • Must be highly organized with strong prioritization skills and possess the ability to manage multiple projects simultaneously., • Must have a valid driver's license, the ability to commute to various locations on a daily basis, and potentially multiple locations during the workday., • Productivity and resiliency in a dynamic, fast-paced consulting environment., • High level of professional judgment., • Must be able to lift up to 50 lbs., • Proficient in the use of Microsoft Office Suite., • Experience and comfort with public speaking. What you need to be successful in this role • Service-oriented with a personable positive attitude., • Ability to successfully negotiate and promote safety programs and services., • Strong initiative to dig into resources efficiently and effectively., • Ability to independently solve problems with little supervision but recognize when help is needed. As an equal opportunity employer, Safety Partners will provide reasonable accommodation for a disability or sincerely-held religious belief where required by law to do so.

Company Description Collard & Roe, P.C. is a distinguished intellectual property law firm that has been serving clients in patent, trademark, and copyright matters since 1966. With a global network of patent and trademark attorneys across more than 70 countries, we provide comprehensive support to clients in all aspects of intellectual property law. Our firm has secured over 10,000 patents and 17,000 trademarks, showcasing a strong legacy of legal excellence. With attorneys averaging more than 20 years of experience, we specialize in areas such as biotechnology, chemistry, computer programming, and engineering as well as maintaining a busy trademark practice. We are dedicated to delivering trusted guidance and innovative legal strategies to clients of all sizes worldwide. Role Description This part-time or full-time role for a Trademark Attorney requires in-office presence in Roslyn, NY, with flexible opportunities for remote work. The attorney will handle trademark-related legal matters, including trademark searches, filings, renewals and opposition proceedings. The responsibilities also encompass working on trademark litigation as well as trademark portfolio management and counseling. The role offers an opportunity to collaborate with a team of experienced IP attorneys and staff to deliver exceptional service to clients throughout the world. Compensation will be commensurate with experience. Expected range of $100,000-$200,000/year for full-time. Qualifications • Strong expertise in Trademark Law, including trademark searches, filings, renewals and opposition proceedings. Minimum 3 years experience preferred., • Strong written and oral communication skills, • Analytical and detail-oriented mindset with strong research and problem-solving skills, • Licensed attorney in good standing in New York, as well as the Federal Courts in SDNY and EDNY, • Willingness to engage in client development, marketing and educational activities

(Senior) Director, Quality Systems – Permanent – New York Proclinical is seeking a (Senior) Director, CMC Quality Assurance for an emerging biotech company based in New York. Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities. The position is based onsite in New York. Skills & Requirements: • B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional., • Experience in small molecule development, batch release, and SOP drafting., • Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections., • Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products., • Proven ability to build or scale quality systems in a dynamic environment., • Prior experience managing CDMOs and external quality oversight strongly preferred., • Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred. The (Senior) Director, Quality Systems will: • Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards., • Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies., • Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations., • Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management)., • Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams., • Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs)., • Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

About the Company: Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. POSITION SUMMARY Reporting to the Sr. Director of Executive Management & Government Affairs, will serve as a key partner within the Office of the CEO, supporting enterprise-wide strategic initiatives, executive decision-making, and cross-functional execution. This role will act as a force multiplier to the CEO Office by driving structured analysis, managing high-impact projects, coordinating cross-departmental priorities, and supporting public affairs and external advisory engagements. The ideal candidate is highly analytical, detail-oriented, politically astute, and capable of operating in a fast-paced, high-visibility executive environment. KEY ROLES AND RESPONSIBILITIES • Executive Strategy & Decision Support, • Provide structured analytical support to the CEO and Chairman (COB) on high-priority business issues., • Develop executive-level briefing materials, board presentations, and strategic recommendation documents., • Conduct financial, operational, and market analyses to inform leadership decisions., • Track and systematize key corporate KPIs and executive dashboards., • Enterprise Project Management & Cross-Functional Coordination, • Support enterprise-wide strategic initiatives by establishing milestone tracking and governance frameworks., • Facilitate cross-functional alignment across commercial, medical, regulatory, finance, and operations teams., • Identify risks, bottlenecks, interdependencies and escalate issues proactively., • Prepare periodic executive progress reports and performance summaries., • Drive Process optimization efforts to improve organizational efficiency and reduce silos, • Public Affairs & External Advisory Support, • Support management of external advisory firms, consultants, and lobbying partners., • Conduct regulatory and policy research and assist in risk monitoring activities., • Prepare briefing materials for government relations and strategic stakeholder engagements., • Maintain structured documentation and tracking of external engagements and outcomes. Prepare daily/weekly/monthly distribution related reports and analyze to monitor performance, • Strategic & Special Projects, • Support planning and execution of high-impact strategic initiatives and confidential executive projects., • Develop business cases, scenario analyses, and financial models., • Conduct competitive intelligence and industry benchmarking., • Ensure disciplined execution from project initiation through post-implementation review. WORK EXPERIENCE • 1–3 years of professional experience in corporate strategy, consulting, business operations, project management, finance, healthcare, or related fields., • Experience supporting cross-functional initiatives or participating in multi-departmental projects., • Exposure to executive-level reporting or presentation preparation preferred but not required., • Experience in regulated industries (e.g., healthcare and biopharma) is a plus., • Internship or early-career experience in strategy, analytics, or operations roles will be considered., • Bilingual, Korean preferred. QUALIFICATIONS • Strong analytical and problem-solving skills with the ability to structure ambiguous issues., • Proficiency in Microsoft PowerPoint and Excel; ability to build clear, data-driven presentations., • Strong written and verbal communication skills., • High attention to detail and organizational discipline., • Ability to manage multiple tasks and prioritize effectively in a fast-paced environment., • Demonstrated ownership mindset and willingness to learn., • Ability to handle sensitive information with discretion EDUCATION • Bachelor’s Degree required in business or related field CORE COMPETENCIES • Strategic Thinking – Ability to connect operational details to enterprise-level strategy., • Executive Communication – Clear, concise, board-ready communication skills., • Analytical Rigor – Data-driven mindset with strong quantitative capability., • Project Discipline – Structured planning, milestone tracking, and accountability management., • Organizational Influence – Ability to navigate complex stakeholder environments without formal authority., • Discretion & Integrity – High ethical standards and confidentiality in handling sensitive information., • Agility & Ownership – Comfortable operating in ambiguity with strong execution bias. Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-MDRD

(Senior) Director, CMC QA – Permanent – New York Proclinical is seeking a (Senior) Director, CMC Quality Assurance for an emerging biotech company based in New York. Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities. The position is based onsite in New York. Skills & Requirements: • B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional., • Experience in small molecule development, batch release, and SOP drafting., • Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections., • Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products., • Proven ability to build or scale quality systems in a dynamic environment., • Prior experience managing CDMOs and external quality oversight strongly preferred., • Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred. The (Senior) Director, CMC QA will: • Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards., • Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies., • Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations., • Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management)., • Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams., • Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs)., • Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

Job DescriptionInvestment Banking Analyst Overview MTS seeks candidates to fill an immediate hire for the position of Investment Banking Analyst. The Investment Banking Analyst will play an important role on the firm’s advisory team, supporting an appropriately staffed team in a broad range of transactions including mergers, acquisitions, divestitures, restructurings, royalty monetizations and capital markets transactions. Candidates can expect to receive a higher level of responsibility and deal execution experience than at peer institutions. Day-to-Day Responsibilities Responsibilities include conducting company and industry research, performing financial and valuation analyses, creating business profiles, and preparing industry overviews on subsectors within the healthcare industry. Financial analyses include creating detailed financial models used for valuation and other financial analysis (DCF, LBO, M&A, accretion/dilution, comparable company and transaction analysis); preparing marketing documents, including pitch materials, confidential offering memoranda, management presentations, fairness opinions and board presentations; conducting extensive financial and industry due diligence to evaluate the risk/return parameters of a transaction. Qualifications Ideal candidates will have ~6-18 months of fulltime, professional experience in the financial services industry and/or consulting. Candidates should have a strong desire to work in investment banking and an interest in the healthcare industry. We are looking for candidates with demonstrated leadership in academics and extracurricular activities and a degree from a top rated institution. We seek young men and women with overall excellent judgment and character, strong quantitative and qualitative analytical skills, knowledge of corporate finance, keen attention to detail, desire to excel, and commitment to contributing to the MTS team culture. Why Choose MTS as a Career MTS Health Partners, L.P. is a fast-paced, collegial environment with a tight-knit culture focused on professional growth. Anchored by the foundation of a well-run partnership, team members have unparalleled access to Senior Bankers and are rewarded with responsibilities commensurate with demonstrated skill and professional maturity. MTS promotes an environment based on teamwork and camaraderie, with an emphasis on entrepreneurship, accountability and innovation. MTS is dedicated to promoting from within the firm and developing each team member’s career. Why Clients Choose MTS as Their Banker MTS Health Partners, L.P., is a preeminent New York City-based healthcare investment bank, providing strategic advisory services related to mergers & acquisitions, divestitures, restructuring, and equity and structured products capital markets transactions for companies in the global healthcare industry. MTS focuses on the following subsectors of the healthcare industry: healthcare services, pharmaceuticals, biotechnology, generics, medical devices and diagnostics. Founded in 2000, MTS is distinguished by its dedicated healthcare industry focus, senior level hands-on deal execution, and the unique perspective and network MTS brings given the deep experience of its senior professional team - all without the conflicts of interest that most banks face. The U.S. and global healthcare industry is currently in the midst of unprecedented growth and change in a volatile economic environment; MTS plays a crucial role in advising our clients as they face critical strategic and financial decisions during these times. Uniquely, MTS’ business model focuses on alignment with our clients, building long-term relationships and engineering and executing the “right” transaction for our client. We specialize in executing complex transactions (e.g. mergers, restructurings, privately negotiated equity, structured debt, hybrid financings) where our “skill” as bankers is more important than the “scale” of an organization, such as in widely syndicated transactions (e.g. follow-on equity offerings, senior debt offerings). However, when a situation calls for a hybrid approach of private negotiation and public syndication, we also have the ability, as a registered broker-deal, and the flexibility to call on our experience and relationships to orchestrate the appropriate deal. Whereas many banks are divided into industry coverage groups and product groups, the same deal team at MTS originates and executes the transaction, thus maintaining control of every aspect of advice, strategy, and execution and avoiding the conflicts of interest seen at other advisory firms. Note:The information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.Expected Annual Salary $110,000-$110,000 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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 IT Support Engineer will be responsible for working with internal users in the organization and assisting with audio-visual and IT related setups and issues. Location: On site 4 days a week in our Manhattan, NYC office. Reports to: Senior IT/AV Manager. Duration: 12-month contract. Roles and responsibilities (Include but are not limited to): • Manage technical tasks related to onboarding and offboarding of Compass users, • Attend the office full time and support end user requests, • Take responsibility for the Zoom Rooms audio-visual technology in every conference room, • Oversee and manage a wide variety of digital platforms such as JAMF, Microsoft, & Atlassian products, • Logging service desk tickets from internal employees and working with them to resolve any technical issues, • Troubleshooting and resolving IT hardware and software issues, • Collaborate on projects with cross functional teams as needed, • Support hardware and software of all end user devices, • Setting up and support end user mobile devices, • VIP support of our senior staff, • Act as Technician on Duty for important US-based conference calls, • Create high quality AV/IT Documentation resources, • Proactively create tasks to improve AV/IT systems and process, • Excellent issue resolution ability for audio-visual conference rooms, Windows, macOS and mobile devices, • High level of understanding of Zoom and audio-visual technology, • Good understanding of corporate mobile device provision and how to solve problems, experience with Intune and JAMF, • High level of understanding and experience of Office 365 & Microsoft products, • Good working knowledge of audio-visual hardware, especially Logitech and Zoom technology, • Experience working in IT work management/ticketing systems, Jira service desk experience a plus, • Ability to prioritize workload and involvement with VIP support, • Strong analytical, project management, written and verbal communication skills, • Previous involvement with on-boarding / off-boarding of employees, • Proficient dealing with digital security threats, • Exceptional problem-solving skills in high pressure situations, • Completely self-sufficient and able to work with minimal supervision & support, • Ability to operate independently and in cross-functional teams under uncertainty in an entrepreneurial and rapid growth-oriented, • Experience working in an ITIL environment, including request, incident and change management processes 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】:$65,000—$85,000 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.

About the Company: Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. POSITION SUMMARY This position will directly report to HR Director to provide support and deliver value-added services on the day-to-day HR operations, employee relations and leadership support. HR Generalist will assist in the execution of a broad range of HR services to include recruitment, payroll processing, onboarding/off boarding, benefits management, and HRIS management. This is a CONTRACT position. DUTIES AND RESPONSIBILITIES : HR Operations & Compliance • Supports onboarding of new hires within platform to include, but not limited to, orientation, documentation processing, I9/WD compliance processes and job offer package implementation., • Facilitates and/or provides training (including orientation) to the workforce., • Assist in implementation and administration and continuous improvement of Celltrion USA employees’ health, welfare, retirement programs and other group benefits including medical, dental, vision, life, disability, and wellbeing initiatives, • Assist in ensuring all benefit programs are aligned and in compliance with all federal, state and local laws and regulations (e.g. FMLA, ADA, COBRA, HIPPA, ERISA, • Assist in managing accommodation, leave administration, workers’ compensation, and return-to-work processes., • Reports and updates if there are any necessary changes and updates resulting in a seamless process with high accuracy, compliance, and strong engagement, • Partners with the HR team on payroll processing, including serving as backup when needed, • Assist with stay and exit interviews Sourcing and Recruitment • Assist in sourcing, screening and scheduling interviews with hiring managers and other related tasks, • Maintains and updates recruitment tracking system in a timely manner, • Assists in posting job requisitions on job boards Project Management • Contribute to HR projects such as policy updates on employee handbook, process improvements, system optimization, • Supports HR leaders with various ad hoc projects Minimum Qualifications/Experience: • Bachelor's degree in Human Resource Management or related HR discipline required., • Minimum 5 years of HR generalist experience within a pharmaceutical, healthcare environment., • Proficiency in HRIS, timekeeping, payroll systems, and Microsoft Office (Excel & PowerPoint);, • Knowledgeable in ADP or Workday experience is a plus. Core Competencies • Digital Agility: Ability to operate, navigate and understand process flows within systems, • Collaboration: Thrives in a matrixed environment and excels working both in teams and independently., • Communication: Strong written, verbal, presenting and interpersonal communications skills, • Critical Thinking: Exhibits ability to effectively analyze basic information and formulate recommendations., • Ensures the highest ethical and professional standards, • Ability to maintain strict confidentiality. Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-MDRD

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 . Description: We are seeking a proactive, resourceful, and detail-oriented Executive Assistant to join our team on a 6-month contract. The successful candidate will play a key role in supporting day-to-day CEO operations, with a strong focus on calendar management, event coordination, and general office support. This is a dynamic and highly visible role where you’ll be a key partner to executives, ensuring seamless day-to-day operations and contributing to broader strategic initiatives. Contract Duration: 6-9 Months beginning November 2025. Potential for full-time employment at the end of the contract based on business need. Responsibilities: • Deliver comprehensive administrative assistance to the CEO, including calendar and inbox management, meeting coordination, document creation, and complex domestic and global travel arrangements., • Serve as a liaison between the CEO and executive leadership team, ensuring alignment and streamlined communication., • Manage the CEO’s professional and personal calendar and provide event support, liaising with family members as needed., • Filter and prioritize incoming requests, communications, and documents for the CEO with the utmost discretion., • Plan and execute internal and external meetings, leadership offsites, and industry events, including communications, logistical components and vendor coordination., • Serve as a primary point of contact for internal and external stakeholders, ensuring timely and professional responses., • Develop agendas for key meetings, capture meeting notes, ensure distribution and follow-through on action items., • Handle ad-hoc administrative tasks and other duties as assigned., • Flexibility to be on site in Brooklyn, based on businesses needs and the schedule of the CEO. Requirements • 3-5 years of administrative experience as an executive assistant or other support role., • Strong organizational and time management skills., • Excellent written and verbal communication., • Advanced in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint), • Outstanding ability to execute reliably and prioritize time and tasks., • Resilience to navigate competing priorities and constant change., • Incredibly proactive and able to work efficiently with little direction., • Resourceful and agile in day-to-day work., • A positive attitude and willingness to learn., • 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, • The compensation for this role is $80-100k per year.

About the Company: Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. POSITION SUMMARY Provide administrative and operational support to the IDN Task Force by managing contract documentation, coordinating cross-functional reviews, and tracking approval workflows. This role focuses on ensuring efficient execution of confidentiality agreements (NDA), direct supplier agreement and consulting agreements through structured documentation control, internal coordination, and compliance tracking. The position does not involve commercial negotiation but plays a critical role in ensuring that contract workflows remain organized, accurate, and on schedule. This position requires a 3 days work on-site at the Jersey City office / 2 days WFH. KEY ROLES AND RESPONSIBILITIES Contract Management & Documentation: • Manage NDAs, direct supplier agreements and consulting agreements, • Track contract status from initiation through execution, • Maintain executed contracts and version history, • Manage contract filing system and document organization, • Monitor open items and alert internal stakeholders of missing approvals Cross-functional Coordination: • Coordinate contract review processes with Cross-functional teams (Legal, Finance, Trade, Pricing), • Ensure required departmental involvement prior to execution, • Follow up on pending reviews and approvals, • Support contract-related scheduling and documentation Compliance Tracking & Process Support: • Maintain and update the contract tracker in real time, • Monitor approval status and completeness of documentation, • Support internal compliance procedures related to contract handling, • Prepare contract status summaries for leadership as needed WORK EXPERIENCE • With 2–5 years of relevant experience in administrative support, contract coordination, operations, or related roles preferred., • Junior to mid-level professionals (Associate to Manager level), • Experience in pharmaceutical, healthcare, or corporate environment preferred, • Exposure to document management, contract tracking, or compliance workflows is a plus, • Project coordination experience is preferred but not required QUALIFICATIONS • Strong organizational skills and high attention to detail, • Ability to manage multiple agreements simultaneously, • Comfortable working with cross-functional teams, • Proficiency in Microsoft Outlook, Excel, Word, and PowerPoint, • Experience with Concur or similar expense or administrative systems preferred, • Ability to handle confidential information appropriately, • Strong written and verbal communication skills, • Bilingual, preferably in Korean EDUCATION • Associate or bachelor’s degree in Business Administration, Management, Healthcare Management, Life Sciences, or a related field CORE COMPETENCIES • Detail-oriented, • Organized and process-driven, • Strong follow-up capability, • Reliable and accountable, • Professional communication skills, • High integrity and discretion when handling sensitive information Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-MDRD

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 DescriptionQuality Control Analytical Associate IIAllendale, 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 Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Under the direction of the Manager, QC Analytical Associate II, responsibilities include: • Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations, • Performs maintenance, monitoring, and troubleshooting of pertinent equipment, • Performs and assists in the training of other Quality Control technicians, • Maintains training records and coordinates records retention with Document Control and Training groups, • Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines, • Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable, • Participates in managing QC materials and supplies, • Performs and assists in equipment and method qualification/validation activities as needed, • Performs reagent and media preparation, • Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment, • Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results, • Initiates, investigates, and prepares deviation reports with input from assigned supervisor, • Brainstorms and implements corrective and preventive actions, as and when applicable, • Documents training and execution of shipping test samples to contract laboratories for testing, • Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Communicates effectively with other co-workers, departments, management and clients, • Eventually serves as a lead and/or co-lead for client projects, • Additional tasks as assignedREQUIREMENTS, • BA/BS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred, • Prior industrial experience in cell count methodologies preferred, • Prior academic and/or industrial cell therapeutic experience preferred, • Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry, • Proficient with computer software such as: Microsoft Office, Visio, • Strong written and oral communication skills, • Strong presentational skills preferred, • 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 responsibilities.Other Information, • 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. The noise level in the work environment is moderately noisy. 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, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Analytical Associate II must be able to work in a laboratory environment for an extended period., • Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hearPlease 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. QC Analytical Associate I is available as well.

Job Description JOB DESCRIPTION: The Supervisor of Veterinary Services and Quality Assurance provides support to the Director of Division of Laboratory Animal Resources (DLAR), the Attending Veterinarian and Animal Facility Manager to maintain the health and welfare of housed animals as well as AAALAC accreditation and continued compliance with all federal and state regulations. Responsibilities include providing best practices to ensure accreditation and regulatory compliance to maintain a high quality humane and ethical animal care and use program. Activities involve periodic collection and processing of biological and /or environment samples and conducting clinical exams, diagnostic procedures, assisting in experimental procedures, protocols, and surgery to include pre and postoperative care for all animal procedures, assist in surgery, also assist in rodent ( and other lab animals when present) research procedures, anesthesiology and surgery. . Under supervision from the Attending Veterinarian may provide or oversee clinical treatment and/or enrichment to research animals. Assists in managing rodent breeding colonies. Maintains and or monitors records of medicinal and or experimental substances and other inventories and procedures related to animal care and use. Oversees Post Approval Monitoring( PAM) of animals on IACUC approved studies to include proper identification of cages and animals according to standard operating procedures. Provides observations and follow up response with the Facility Manager to conditions of animal rooms and support areas, ensures the appropriate provision of supplies present including personal protective equipment (PPE). Direct or guide staff assessing, sampling, testing of animals for colony and individual health, environmental enrichment, research use, and medical care of injured or sick animals. JOB DUTIES: • Direct and train staff in animal husbandry/breeding colony maintenance and monitoring, animal enrichment and veterinary services as appropriate, • Animal health monitoring and treatment under guidance by the Attending Veterinarian, • Rederivation of conventional rodents to specific pathogen free status, • Occupational health and safety in the facility, • Animal import and export, • Monitoring and sampling of the facility environment, • Maintain Veterinary Equipment, Operating Room (OR) suite and procedure rooms, • Genetic monitoring/tail cutting/identification services, • Research animal procedures, • Assists in preparation of Annual Facility Operating Budget and facility material orders as needed, • Assists in census and cost recovery procedures, • Scheduling Animal Facility Staff, • Collaboration in IACUC approved research studies, • Attends research planning, participates when requested or appointed on institutional committees such as the IACUC and IBC, • Training, • Euthanasia JOB QUALIFICATIONS: Minimum Qualifications: Bachelor's degree, Licensed Veterinary Technician and four years of professional experience in a Laboratory Animal Care and use Program. Substitutions: Masters degree or higher in biotechnology, or animal science and Certification as Laboratory Animal Technologist( LATG) or Manager (CMAR) with at least three years experience in a research animal care and use program. Ph.D in appropriate field may substitute an additional year of experience. Preferred Qualifications: Veterinary Degree with a current license to practice in New York, Board Eligible in the specialty of Laboratory Animal Medicine. Background Investigation/Justice Center Review Requirements: Prospective appointees will be: 1) Checked against the Staff Exclusion List (SEL) maintained by the Justice Center for the Protection of People with Special Needs. Prospective employees whose names appear on the SEL as having been found responsible for serious or repeated acts of abuse or neglect will be barred from appointment. 2) Screened against the Statewide Central Register of Child Abuse and Maltreatment (SCR). Prospective employees whose names are indicated on the SCR may be barred from appointment. *The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees, do not participate in any state retirement system, and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action/Equal Opportunity Employer - Disabled/Veteran, 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a) compliant. Applications will only be accepted through website at: - Click on Employment Opportunities. Applications will be accepted only during the posting dates as listed at the top of the job announcement. Questions regarding this position please email: Job Posted by ApplicantPro

Job Description Job Title: QA Associate 1st Shift (TUES-SAT) Job Description We are seeking a dedicated QA Associate for the 1st Shift (Tuesday to Saturday) to ensure the highest standards of quality and compliance within our manufacturing operations. The role involves reading, understanding, and following cGMP and cGTP documentation for Quality System Functions, ensuring compliance in all aspects of pre-clinical, clinical, and commercial manufacturing. Responsibilities • Maintain cGMP and cGTP compliance for all manufacturing processes., • Perform raw material inspections and release according to SOPs and regulatory standards., • Issue and maintain all cGMP and cGTP documentation, including logbooks and training binders., • Perform accessioning of incoming apheresis and line clearance prior to manufacturing operations., • Build quality into all work aspects by adhering to all quality requirements., • Ensure compliance with all FDA and Worldwide Quality & Compliance regulations., • Attend all required Quality & Compliance training sessions., • Strong quality assurance skills., • Experience with batch record review and material flow., • Ability to perform under direct supervision., • BS degree in a scientifically related field., • Experience in a biologics or biotechnology company is preferred., • Technical understanding of aseptic manufacture of biologics is preferred. The role requires working in a team-oriented environment and interacting with clients. The position demands availability during weekends, holidays, and other times as required by the company. The work environment may expose you to infectious diseases and requires proper use of personal protective equipment (PPE). You will be working with specialized equipment and handling the standard/moderate noise levels of a manufacturing facility. Training in GXP, SOP & WI, Safety, and Gowning qualification is provided. Job Type & Location This is a Contract to Hire position based out of Allendale, NJ. Pay and Benefits The pay range for this position is $30.00 - $30.00/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 • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Mar 25, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

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 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 DescriptionQuality Control Microbiology SupervisorAllendale, NJ The Quality Control Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Team Leadership - Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles: QC Microbiology Associates, • Investigate and document non-confirming events and environmental excursions., • Troubleshoot and recommend process improvements to achieve greater efficiency ad meet quality goals., • Interact with other Microbiology departments on a regularly scheduled basis to discuss and harmonize best practices, procedures and processes between the sites., • Participate in department and cross functional meetings., • Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Author and revise Standard Operating Procedures, Work Instructions, forms and Protocols to reflect current practices., • Perform microbiological and environmental monitoring data review. Compile and issue quarterly and annual Environmental Monitoring trending reports., • Provide staff development through feedback aimed towards performance development and review., • Ability to remain focused and effective in high stress situations., • Builds constructive working relationships characterized by a high level of acceptance, cooperation, and mutual respect., • Able to handle challenging interpersonal relationships., • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Aseptic Processing StandardsREQUIREMENTS, • BS in Microbiology or relevant field required., • Biotechnology Certificate and/or cGMP experience, • Minimum of 3 years of experience with environmental monitoring or within the biopharmaceutical industry., • Strong knowledge of microbiological test methods, philosophies, method validation and method transfer., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office, Excel, and MODA., • Must have ability to work in a team-oriented environment and with vendors., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The employee must be able to comply with personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role., • An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects., • Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear., • The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance), • Heavy cryo-gloves must be used when working with liquid nitrogen, • 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. The noise level in the work environment is moderately noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAbout 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 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 Description Who We Are: Oppenheimer & Co. Inc. (“Oppenheimer”) is a leading middle-market investment bank and full-service broker-dealer. With roots tracing back to 1881, the Company is engaged in a broad range of activities in the financial services industry, including retail securities brokerage, institutional sales and trading, investment banking (both corporate and public finance), equity & fixed income research, market making, trust services and investment advisory and asset management services. Job Description: The firm is currently seeking a Senior Research Associate to join our Biotechnology equity research team. The position is located in New York City. As a Research Associate, you will work directly with the Senior Research Analyst on many aspects of the research process including: building and maintaining financial models, performing fundamental analysis and due diligence on biopharmaceutical companies, writing investment-driven research reports, developing and fielding industry surveys, attending medical and scientific conferences, and undertaking a wide array of industry analyses and competitive assessments. The associate will have broad exposure to company management and investor conferences, and will interface with key opinion leaders, institutional investor clients, and internal sales force and trading personnel. Our ideal candidate has an undergraduate degree in a related field of study, including biology, chemical engineering, biochemistry, biomedical engineering, biotechnology, molecular biology, genetics, or pharmacology. An advanced degree (MSc, PHd, MBA) is required. Minimum of two years of sellside equity research experience is required. The ideal candidate pays excellent attention to detail, is skilled at time management, has a strong work ethic, effective oral and written communication skills, and an outstanding academic record. A strong candidate is independently motivated, analytically-minded, and intellectually curious; possesses at least some experience with financial modeling and exposure to the equity markets; and, has a passion for life sciences investing. We look for people who possess the following characteristics: • Exceptional academic background., • A thorough understanding of the investment process and the ability to perform deep primary research., • Excellent quantitative and financial modeling skills. Associates are responsible for building and maintaining company financial models and for organizing and updating industry data., • Strong writing skills. Associates are responsible for authoring equity research reports, company initiations, industry reports, and marketing presentations—sometimes under tight time constraints., • Responsiveness, professionalism, and the ability to manage priorities to meet deadlines., • Experience in biopharmaceuticals equity research, drug development, or related field preferred., • Proficiency in Microsoft Office; FactSet, Bloomberg would be a bonus. For job postings in New York State, Oppenheimer is required by law to include a reasonable estimate of the salary range for this role. This salary range is specific to the State of New York and takes into account the wide range of factors that are considered in making salary decisions including but not limited to your skills, qualifications, experience, licensure and certifications, and other business and organizational needs. A reasonable estimate of the current base salary range is $150,000.00 - $200,000.00 at the time of this posting. Also, certain positions are eligible for additional forms of compensation such as discretionary bonus

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 Description The Quality Assurance Technician is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon’s products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP). Position is for 2nd shift. Responsibilities: • Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager., • Perform line clearance activities and in-process inspections., • Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below), • Transfer materials between facilities (see lifting requirements below), • Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215, • Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232, • Operate testing equipment such as force testers, torque testers, and balances., • Report all deviations in product, components, raw materials, and equipment per their relevant procedures, • Perform document control activities, including but not limited to printing logbooks and batch records., • Transcribe data into digital systems for tracking Quality Metrics., • Batch record review & support routine batch disposition Requirements Education: High School Diploma or Equivalent (2- or 4-year degree in Engineering, Science, or Technology/Biotechnology preferred) • Required experience in GMP and FDA regulated environments (ISO 13485:2016 preferred), • Ability to be Gowning Qualified per Cresilon’s SOP., • 1 year experience in regulated industry highly desirable · 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 The salary for this role is $25/Hour 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.

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

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

Job DescriptionAssociate General Counsel Fully Remote | Fast-Growing Biotech/Pharma Company Compensation: $200,000 – $300,000 Base + More Join a mission-driven biotech company transforming the future of rare autoimmune disease treatment. We’re developing innovative therapies for patients who need them most—and we’re looking for a strategic legal partner to help guide our growth. About the Role We’re adding an Associate General Counsel to our dynamic legal team. Reporting directly to the General Counsel, you’ll be a key business partner across the company, providing practical legal advice, driving compliance initiatives, and ensuring that we move fast while staying grounded in ethics and integrity. This is an opportunity to do meaningful work at the intersection of science, law, and business—where your impact will be felt across patients, employees, and the broader healthcare community. What You’ll Do * Keep Us Compliant: Navigate the complex biotech regulatory landscape and ensure we’re ahead of the curve on evolving laws. * Strengthen Our Culture of Integrity: Develop and deliver engaging training on compliance topics—from our Code of Conduct to anti-bribery and anti-kickback rules—while continuously refining company policies. * Be a Deal-Maker: Draft, review, and negotiate critical agreements (clinical trial, licensing, manufacturing, research collaborations, vendor, and more). * Enable Commercial Success: Partner with the commercial team to review promotional materials, advertising, and other go-to-market initiatives. * Protect and Empower: Spot legal risks early, propose smart solutions, and balance business agility with compliance. * Collaborate Across Teams: Work side-by-side with colleagues in R&D, Regulatory Affairs, Quality, HR, Finance, and Commercial to deliver clear, actionable guidance. * Be a Trusted Advisor: Foster trust at every level of the organization, championing ethical business practices and sound judgment. What You’ll Bring * JD (or equivalent) with active bar membership in good standing. * 10+ years of legal experience in biotech, pharma, or life sciences (in-house or at a top firm advising clients in these sectors). * Deep knowledge of the regulations shaping the biotechnology industry. * Proven success drafting and negotiating complex agreements. * Familiarity with global privacy frameworks (e.g., GDPR). * A reputation for providing clear, business-oriented legal counsel in fast-moving environments. * Exceptional communication and relationship-building skills—you can talk science with scientists, strategy with executives, and compliance with employees. * Impeccable ethics, attention to detail, and the ability to juggle multiple priorities without losing focus. Why Join Us? This isn’t just another legal role. It’s a chance to help shape a high-growth biotech company as it brings life-changing medicines to market. You’ll work with passionate, driven colleagues in a collaborative environment where your voice matters and your work has a direct impact on patients’ lives. If this sounds like something you are interested in, apply today!

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

Job 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 Description This is a remote position. Our client, a world leader in biotechnology and life sciences, is looking for a "Training Coordinator" (Fully Remote). Rate: $35/hr on W2 Job Duration: Long-Term Contract (Possibility Of Extension & FT Conversion) Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K Key Responsibilities • Administer and manage training activities within an LMS (Cornerstone preferred), including curricula creation, learning assignments, user groups, and reporting, • Coordinate training schedules, logistics, and train-the-trainer sessions, • Partner with Global Training, OCM, and business teams to align training with deployment milestones, • Track training readiness, attendance, risks, and mitigation plans, • Support migration and retirement of local training materials, • Provide ongoing support during deployment and hypercare phases Qualifications • 3+ years of experience in training coordination or LMS administration, • Hands-on experience with Learning Management Systems (Cornerstone or similar), and managing logistics, systems, and reporting, • Project coordination skills is a plus, • Strong organizational, coordination, and stakeholder communication skills, • Proficient in Excel (pivot tables, VLOOKUP, reporting), • Experience supporting enterprise system or ERP implementations is a plus, • Ability to work with global teams across time zones If interested, please send us your updated resume at .

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 Senior Director, Site of Care Marketing will be a critical and highly visible leader within the US Commercial team, responsible for developing and executing strategies to activate and expand sites of care, improve speed to therapy, and coordinate the complex care pathway between interventional psychiatry and other disciplines. This position is responsible for establishing strategic direction through analysis of insights to drive key strategic choices and support a historic launch for COMP360 in patients who have failed treatment with at least two antidepressants (ADs). This role focuses primarily on HCP and site‑of‑care experience initiatives, while also requiring the ability to collaborate on and lead projects that support the intersection between prescribing HCPs, care teams, patients, and families. Location: Hybrid in our New York City office or remote on the east coast in the United States. Reports to: Chief Commercial Officer. Roles and responsibilities (Include but are not limited to): Site of Care Strategy & Leadership • Lead and set the direction for strategies to support site of care excellence, education, infrastructure, operations, and key solutions to coordinate care, • Manage overarching strategic relationships internally and externally, including 3rd‑party service and solution partners, in the development and execution of market strategies, • Set strategic direction and execution guidance for customer‑facing teams as they engage sites of care to address barriers to treatment, • Manage complex and innovative projects, establishing vision and direction within a fast‑moving, challenging, and dynamic commercial environment, • Lead the creation of innovative strategic plans while driving execution of complex product growth opportunities and delivering measurable results, • Develop and execute Site of Care marketing strategy and tools in alignment with overall brand strategy and objectives, • Collaborate with Sales Operations to identify referral pathways and sites of care for potential treatment of patients with COMP360, • Lead a team of Health System Account Managers (and dotted line oversight of Thought Leader Liaisons) to negotiate with health systems and clinics, remove barriers to care, establish protocols and care pathways, and develop tools tailored to different site‑of‑care archetypes, • Partner with Patient Engagement to identify priority sites of care and referral pathways, and build targeted programs that address their needs, • Collaborate with Sales, Marketing, Access, Patient Engagement, and other matrix partners to prioritize mission‑critical marketing strategies, • Address marketing bottlenecks and complex treatment processes across diverse sites of care, • 10+ years of experience in the biotechnology or pharmaceutical industry, with exposure to site‑of‑care strategy, HCP engagement, commercial execution, or market development, • Strong understanding of care delivery models, referral pathways, and operational barriers that influence speed to therapy, • Demonstrated ability to lead cross‑functional initiatives and collaborate effectively with Sales, Market Access, Medical Affairs, and Patient Engagement, • Experience managing complex, high‑impact projects in dynamic commercial environments, balancing strategy with hands‑on execution, • Skilled in building productive relationships with health systems, clinics, and external solution partners, • Strong analytical and problem‑solving skills, with the ability to turn insights into clear strategic recommendations, • Excellent communication and influence capabilities, with the ability to guide customer‑facing teams and align stakeholders, • Adaptable, organized, and comfortable operating in fast‑changing, ambiguous environments Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$250,000—$330,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are hiring a highly experienced Quality Director to join our team. The Director of Quality provides enterprise‑level leadership for quality governance, compliance oversight, and risk management across clinical development and research activities. This role is accountable for ensuring that clinical programs, laboratory operations, and external partners operate in alignment with global regulatory expectations and internal quality standards. As a senior leader, the Director of Quality partners closely with executive and functional leadership to embed quality by design, maintain inspection readiness, and support company-wide development programs. • Lead and execute the organization’s clinical and research quality strategy, ensuring alignment with GCP, GLP, internal standards, and global regulatory requirements., • Serve as the senior authority for quality governance, compliance oversight, and inspection readiness across development programs., • Establish, maintain, and continuously improve the Quality Management System, including SOP governance, training, deviation management, and CAPA processes., • Design and oversee risk‑based audit programs and provide quality oversight of CROs, laboratories, and other external partners., • Ensure regulatory inspection readiness through strong documentation practices, data integrity controls, and TMF oversight., • Partner cross‑functionally to integrate quality into clinical development plans, protocols, and operational execution., • Lead quality risk assessments, track key quality metrics, and communicate risks and trends to executive leadership., • Build, mentor, and lead a high‑performing quality organization while fostering a culture of integrity and continuous improvement. Requirements • Advanced degree in a related technical field., • 10–25 years of progressive experience in quality leadership within the pharmaceutical or biotechnology industry., • Deep expertise in GCP and GLP regulations supporting clinical development and research., • Demonstrated success leading quality systems, audit programs, and inspection readiness initiatives., • Strong understanding of global regulatory frameworks (FDA, EMA, ICH, and related authorities)., • Proven ability to influence senior stakeholders and operate effectively in a matrixed environment., • Exposure to complex or specialized therapeutic areas., • Background in quality support for strategic partnerships, licensing transactions, or acquisitions., • Prior experience building or scaling quality organizations in growing or evolving companies., • Must be authorized to work in the U.S., • No C2C at this time. BenefitsW2 temp roles include our Medical and sick time benefits. Adhering to the requirements of New York's law on salary transparency, the salary bracket for this role is set between $125,000 - $155,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RT1

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 DescriptionLife Sciences Technology Transactions Associate – New York Direct Counsel is representing an Am law firm seeking a mid-level Associate (5–7 years) to join its nationally recognized Technology Transactions team in New York. The team advises leading life sciences companies—including biotechnology, pharmaceutical, medical device, digital health, diagnostics, and discovery tools—on licensing, collaboration, and strategic transactions. This role offers exposure to high-profile clients, dynamic deals, and opportunities for professional growth in a collaborative environment. Key Qualifications: * J.D. and admitted to practice in the local jurisdiction * 5–7 years of transactional and licensing experience at a top law firm representing life sciences companies * Strong drafting, negotiation, and client counseling skills * Experience with collaboration, licensing, supply, and other complex commercial agreements, including M&A * Scientific or business background (biology, chemistry, engineering, pharmacy) is a plus * Proven ability to manage multiple projects, mentor junior attorneys, and provide practical business-focused solutions Compensation: $365,000 – $420,000 per year, based on experience; discretionary merit bonuses may apply Benefits: Comprehensive benefits include healthcare coverage for employees and eligible family members, 401(k) retirement plan, paid parental leave, family-building benefits, monthly wellness reimbursements, emotional and behavioral health support, childcare and parenting resources, Health Savings Accounts with firm contribution, flexible spending accounts, and other wellness and professional support programs.

Job Description Job Summary: Montclair Breast Center, a member of Genesis Health, is dedicated to saving lives through proactive healthcare. Our patients enjoy the unique experience of state-of-the-art, personalized care linked seamlessly to the latest screening, diagnostic and preventive technologies. MBC is seeking a mammography tech, responsible for detecting breast tissue abnormalities by completing mammographic imaging studies; presenting them for diagnosis. Essential Functions: • Minimizes radiation to patient and staff by practicing radiation protection techniques. adjustments for optimum results; retaking mammograms as required; forwarding completed studies to radiologist for interpretation. inventories. • Maintains safe, secure, and healthy work environment by following, and enforcing standards and procedures., • Documents patient mammogram services by completing patient record charting., • Quality Assurance- daily, monthly test on mammo stereo bone density., • Making CO’s + downloading., • Risk Assessment on all patients., • Also see attached Flat Field Digital QC Tests 2000DS, Flat Field Digital QC Test Essential, and QA Assurance Policy. Qualifications: • Current State License and ARRT registry, • Specialized training in mammography (continuing education/certificates), • Continuing education- this requirement specifies that an average of 5 ECE’s/year be specific to mammography), • Continuing experience in mammography (effective 4/1999), • High school graduate or equivalent, • Current BLS- Preferred, • Technologists (ARRT) and/or Certified Radiologic Technologist (CRT) Certified sonographer., • Mammographic Radiologic Technology certified., • Able to operate sophisticated computer equipment, • Strong interest in scientific and technical skill and knowledge, • Able to interact compassionately and effectively with the sick or injured, • Able to communicate effectively, • Able to perform well independently, • Able to follow detailed instructions, • Exact and precise, • Highly self-motivated Lifting Requirements Heavy lifting: up to 100 lbs. maximum with frequent lifting and/or carrying objects weighing up to 50lbs. Must be able to stand, stoop and lift and walk without restrictions Workplace Conditions: Workplace Environment Conditions • Medical office environment, • The noise level in this workplace is mild to moderate Visit us at MBC is part of Genesis Health and Genesis Global Group and is an equal opportunity employer. Company DescriptionGenesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.Genesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.

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 . Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, 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 · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement 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.

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 . Description: The Senior Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation, including prototype design and fabrication, and data generation through designed experiments. The Senior Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what’s necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities • Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use., • Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety., • Lead cross-functional teams to develop new products, address design issues, and maintain existing designs., • Apply strong problem-solving skills to find solutions to complex problems., • Work independently to plan and schedule own activities necessary to meet project timelines., • Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success., • Lead the creation of design history file documentation through the new product development process., • Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications., • Generate technical protocols/reports to support device safety and efficacy., • Invent/create concepts and designs and submit invention disclosures., • Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses., • Author protocols and reports including development studies and design verification/validation activities., • Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • 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., • Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Provide support to marketing and sales team, support the introduction of new technologies with the 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., • Manage part-time staff as a research leader and mentor for ongoing research projects., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization., • Provide other project or product support as needed in order to support Cresilon’s business objective. Required Qualifications • BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline., • A minimum of 5+ years of product development experience is required., • A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred), • Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment., • Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans., • Experience leading complex product development initiatives from concept through product launch/release., • Good working knowledge of anatomy and surgical procedures is required., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies., • Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks, • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Requires strong leadership skills, excellent written and verbal communication and presentation skills., • Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007., • Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP), • Good understanding of statistical tools and validation/verification techniques., • Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required., • Legal authorization to work in the United States is required. Preferred Qualifications • An advanced degree (MS or Ph.D.) is strongly preferred., • Hands-on experience in product development with Class II and Class III medical devices., • Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs., • Experience with IDE and PMA submissions., • Six-Sigma green belt or black belt certification 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 $100,000 - $160,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

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 Senior Director, Patient Engagement Operations will lead the strategic design and operational build of a scalable, patient-centred engagement model to support anticipated commercialization of a novel therapy in mental health. Reporting to the VP, Patient Engagement, this leader will partner cross functionally to ensure that operational and commercial strategies reduce barriers to care, accelerate patient access, and optimize real-world outcomes. This role will architect and operationalize patient services infrastructure while incorporating the patient voice into launch readiness and go-to-market planning. This includes, but is not limited to hub services, specialty pharmacy, access coordination, affordability solutions, field integration, and digital engagement. The ideal candidate brings compassion and deep expertise in specialty launch, access strategy, vendor governance, and patient services within a highly regulated environment. Location: Hybrid in our New York City office or remote on the east coast in the United States. Approximately 20-30% travel. Reports to: VP, Patient Engagement. Roles and responsibilities (Include but are not limited to): • Design and implement a patient engagement operating model aligned with commercial, medical, and access strategies, • Lead development of patient support programs (e.g. onboarding, benefits investigation, affordability programs, adherence support), • Identify and operationalize solutions to reduce barriers to care, reimbursement, and treatment initiation, • Partner with Market Access to align program design with payer strategy, coverage policy, and reimbursement pathways, • Oversee vendor selection, contracting, performance management, and governance for support services, • Establish KPIs, dashboards, and analytics to measure Time-to-therapy, conversion, persistence, and overall patient experience, • Ensure inspection readiness and compliance with FDA guidance, HIPAA, OIG regulation, and applicable REMS requirements, • Collaborate with Brand, Medical Affairs, Compliance, Legal, PV, and IT to ensure integrated and compliant execution, • Lead launch readiness planning for patient engagement capabilities, including SOP development and training, • Develop processes to systematically capture and integrate patient insights into operational and commercial decision-making, • Manage program budgets, forecasting, and financial oversight, • Bachelor's degree required; advanced degree (MBA, MPH, PharmD or equivalent) preferred, • 7+ years of leadership experience in patient engagement or operations within the biopharmaceutical or life sciences industry. Experience in mental health or neuroscience is highly preferred, • Patient-centric leader who integrates compassion with operational rigor, • Strategic systems thinker with demonstrated experience supporting launch of specialty or novel therapies, specifically in designing patient support services and/or access programs, • Strong financial acumen and experience managing budgets and external partners, • Data-driven decision maker with expertise in KPI development and performance optimization, • Soft Skills: Deep empathy, exceptional communication skills, and the ability to navigate sensitive topics with rigour and compassion, • Background in REMS, hub operations, specialty pharmacy, patient services program operations, and compliance governance 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】:$220,000—$270,000 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 Who We Are: Oppenheimer & Co. Inc. (“Oppenheimer”) is a leading middle-market investment bank and full-service broker-dealer. With roots tracing back to 1881, the Company is engaged in a broad range of activities in the financial services industry, including retail securities brokerage, institutional sales and trading, investment banking (both corporate and public finance), equity & fixed income research, market making, trust services and investment advisory and asset management services. Job Description: Oppenheimer & Co. Inc., a leading mid-tier investment bank, is currently seeking a Research Associate to join our Biotechnology equity research team. The position is located in New York City. As a Research Associate, you will work directly with the Senior Research Analyst on many aspects of the research process including: building and maintaining financial models and market trackers, performing fundamental analysis and due diligence on biotechnology companies, writing investment-driven research reports, developing and fielding industry surveys, attending medical and scientific conferences, and undertaking a wide array of industry analyses and competitive assessments. The associate will have broad exposure to company management, scientific and investor conferences, and will interface with key opinion leaders, institutional investor clients, internal sales force and trading personnel. A strong candidate is independently motivated, analytically-minded, and intellectually curious; possesses one to two years of experience in equity research or a related field with financial modeling and exposure to the equity markets; and has a demonstrable interest in drug development, and a passion for life sciences investing. Attention to detail, a strong work ethic, the ability to multi-task, and excellent written communication skills are required. We prefer candidates with an undergraduate degree in biology or similar field. An advanced degree (MS/PhD/MD/MBA, etc.) would be a plus but is not a requirement. We look for people who possess the following characteristics: • Strong writing and analytical skills. Associates are responsible for writing and producing equity research reports, company initiations, and marketing presentations—often under very tight time constraints;, • Strong financial modeling, accounting, valuation, and quantitative skills. Associates are responsible for building and maintaining integrated models and for organizing and maintaining industry data—attention to detail is critical;, • A passion for the biotechnology sector, stock market and equity research. It is highly advantageous to have prior exposure to the financial markets and equity research, as well as the day-to-day responsibilities of an equity research associate;, • A thorough understanding of the investment process and the ability to perform deep primary research;, • Strong communication skills. As time progresses, associates will interact with internal sales and trading and external clients; responsiveness and professionalism is important;, • Strong work ethic. An ability to perform duties under minimal supervision and be or become fully-registered with FINRA for SIE/S7/63/86/87 within 12 months after starting; For job postings in New York City, Oppenheimer is required by law to include a reasonable estimate of the salary range for this role. This salary range is specific to the City of New York and takes into account the wide range of factors that are considered in making salary decisions including but not limited to your skills, qualifications, experience, licensure and certifications, and other business and organizational needs. A reasonable estimate of the current base salary range is $100,000.00 - $150,000.00 at the time of this posting. Also, certain positions are eligible for additional forms of compensation such as discretionary bonus.

Job DescriptionCompany Description At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. Job Description THE POSITION: The most important aspect of the position of the Associate Director of Global Medical Affairs is being responsible for managing complex projects across medical content development, Medical / Legal / Regulatory (MLR) Review, Medical Affairs (MA) Operations & Excellence, etc. This role also serves as both Client Manager and Project Manager for these projects. Additionally, this individual will be part of the MA leadership team that will support development of MA strategies, solution offerings, technology / innovation, and building and managing MA teams. This person will collaborate closely with other global leaders within our Global Medical Information and Medical Affairs service line and other business units across EVERSANA to further strengthen the vision of an Integrated Medical Affairs solution offering. This person may partner with other Medical Affairs leads by managing multiple complex deliverables for internal and external clients with a team of resources, including both full-time employees and consultants. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: Project & Client Management • Lead and manage complex, cross-functional Medical Affairs projects, including medical content development, MLR (Medical/Legal/Regulatory) review processes, MA operations, and MA consulting., • Serve as the primary Client/Project Manager for assigned client projects, ensuring timely delivery, quality standards, and strategic alignment with client objectives., • Contribute to the development and execution of Global Medical Affairs strategies, aligning with broader organizational goals and client needs., • Actively participate in the MA leadership team to shape solution offerings, drive innovation, and support business growth., • Support the design and implementation of scalable Medical Affairs models and frameworks across therapeutic areas and geographies., • Lead and manage the development of the positioning and marketing information related to EVERSANA’s Medical Affairs Excellence & Strategy and related consulting services. Including, oversight of capabilities presentations, development of case studies, white papers, publications, and information on EVERSANA.com., • Drive continuous improvement in Medical Affairs operations, including process optimization, technology adoption, and performance metrics., • Champion the integration of digital tools and platforms to enhance medical content delivery, stakeholder engagement, and operational efficiency., • Partner closely with leaders across Global Medical Information, Global Medical Affairs, and other EVERSANA business units to deliver integrated, best-in-class solutions., • Facilitate cross-functional alignment and communication to ensure consistency and excellence in Medical Affairs deliverables., • Build, mentor, and manage high-performing Medical Affairs teams, fostering a culture of collaboration, accountability, and professional growth., • Support recruitment, onboarding, and training of new team members (FTEs and consultants) to ensure capability alignment with evolving business needs., • Cultivate Trusted Partnerships: Build and maintain strong, long-term relationships with client stakeholders, acting as a strategic advisor and trusted partner in Medical Affairs transformation., • Client Satisfaction & Retention: Monitor client satisfaction through regular check-ins, feedback loops, and performance reviews; proactively address concerns to ensure high retention and repeat business. EXPECTATIONS OF THE JOB: • Hours: Monday-Friday, 40+ Hours/week An individual in this position must be able to successfully perform the expectations listed above. Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. • Medical / Scientific degree, PharmD, MD, PhD, etc., • 5+ years of experience in Medical Affairs within the pharmaceutical, biotechnology or device/diagnostics industry, • Demonstrated experience with project management, including vendor and / or technology management, • Experience with Medical Affairs Operations and Excellence across Medical Information, Medical Communications, HEOR, Investigator Initiated Studies, Independent Medical Education, Evidence Generation, etc., • Results driven and team-oriented, with the ability to influence outcomes as necessary, • Able to innovate, analyze, and solve problems with minimal supervision. Passion for technology, innovation (including AI), and process improvement, • Exceptional attention to detail and communication skills, • Demonstrated ability to manage multi-client projects simultaneously while advancing company goals / initiatives, • Ability to communicate and interact effectively with clients The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands. Additional Information OUR CULTURAL BELIEFS: Patient Minded I act with the patient’s best interest in mind. Client Delight I own every client experience and its impact on results. Take Action I am empowered and empower others to act now. Grow Talent I own my development and invest in the development of others. Win Together I passionately connect with anyone, anywhere, anytime to achieve results. Communication Matters I speak up to create transparent, thoughtful and timely dialogue. Embrace Diversity I create an environment of awareness and respect. Always Innovate I am bold and creative in everything I do. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on LinkedIn | Twitter

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

Job Description 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 . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • 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 • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the product and process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. 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 $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job DescriptionJob Title: QA Associate 2nd Shift (Tuesday - Saturday)Job Description The QA Associate will play a crucial role in maintaining compliance with cGMP and cGTP standards across pre-clinical, clinical, and commercial manufacturing processes. This position involves performing raw material inspections, issuing batch records, and managing various cGMP and cGTP documentation. The role requires a strong commitment to quality and compliance with FDA and worldwide regulations. Responsibilities • Read, understand, and follow all cGMP and cGTP documentation for Quality System functions, including SOPs and Work Instructions., • Maintain compliance with cGMP and cGTP standards for all manufacturing processes., • Perform inspections and release of raw materials according to SOPs and regulatory standards., • Issue batch records and review intermediate media batch records., • Manage cGMP and cGTP documentation such as logbooks and training binders., • Perform accessioning of incoming apheresis., • Conduct line clearance prior to the start of manufacturing operations., • Ensure compliance with FDA and worldwide quality and compliance regulations., • Attend required quality and compliance training sessions.Essential Skills, • Quality assurance expertise, • Batch record review, • Knowledge of cGMP and cGTP regulations, • Experience with quality system functions and document managementAdditional Skills & Qualifications, • BS degree in a scientifically related field, • Experience in a biologics or biotechnology company preferred, • Technical understanding of aseptic manufacture of biologics is preferred 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 • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Mar 25, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.