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Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Director, Product Quality provides strategic direction for Compass product manufacture and distribution through internal and external partnership development. This role ensures quality strategies across Compass operations and throughout the product lifecycle for all Compass products, maintaining alignment with GMP/GDP requirements. The Director, Product Quality also guides the Compass QMS to ensure processes adapt to changing business needs, company goals, and GxP regulatory requirements. Location: Hybrid in our New York City office or remote on the East coast, USA. Reports to: Vice President, Quality. Roles and responsibilities (Include but are not limited to): QA Expertise * Maintain oversight of current and evolving global regulatory requirements, proactively assessing impact to Compass products and developing remediation plans where required * Provide subject matter expertise in GMP and GDP, ensuring consistent application across internal and external operations Leadership * Drive enterprise Quality strategy across Supply Chain, Manufacturing, and QMS to reduce operational risk, optimize performance, and support the Compass business through growth and transformation * Lead, develop, and coach the Product Quality team, building strong Quality capability and enabling effective Quality partnerships across the organization * Act as the primary Quality point of contact for Compass Supply and Contract Manufacturing Organizations (CMOs) * Provide Quality support and oversight for Manufacturing and Supply, spanning both IMP and commercial supply chains * Deputize for VP, Quality when required Product Quality Management * Define and implement phase‑appropriate ways of working with external partners, ensuring alignment with Compass strategies and regulatory expectations * Manage all Quality aspects of commercial readiness activities, within Compass and across the extended supply chain * Drive strong, collaborative Quality relationships with CMOs, ensuring alignment with Compass QMS requirements and commercialization objectives * Build a robust and resilient supply chain while ensuring compliant, cost-effective processes that support profitable growth * Provide strategic Quality direction to support dual supply for clinical (IMP) supply and a fully commercial supply chain Candidate Profile: * Broad based knowledge of the pharmaceutical industry at least 12 years' experience in the industry of which 7 should be at a managerial level. * Scientific/engineering degree or equivalent combination of education and experience * Postgraduate qualification in Quality Management or equivalent combination of education and experience * A proven understanding of GMP, GCP, Pharmacovigilance and Quality Management requirements as applied in the industry * Excellent understanding of continuous improvement in a pharmaceutical environment * A passion for continuous improvement and experience applying techniques such as RCA root-cause analysis, CAPA, Lean, Six Sigma * Ability to identify appropriate KPI's, implement and use as control mechanisms and drive change and improvement * Extensive experience of establishing and leading the QMS system and process, in a highly regulated environment across multiple sites, GxPs and locations * Proven ability to present effectively to all levels of an organization to include project rationale and updates, strategic plans * Ability to build effective relationships (internal and external) * Excellent verbal and written communication skills, including the ability to interact effectively with different audiences * Excellent networker with the ability to collaborate and agree outcomes * Ability to understand quality issues in a complex a highly regulated environment and make data driven recommendation/decisions and take appropriate action * Proven record of leading management and staff to deliver business plans 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$180,000—$240,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Founded in 2009, EDETEK is a global leader in clinical technology and services, delivering high-quality, AI-powered platforms and solutions to pharmaceutical, biotechnology, and medical device companies. With a presence across four continents and a client base of over 100 biopharmaceutical companies, EDETEK is transforming clinical development through cloud-native technologies, intelligent data management, and automation. Our platforms are built for scalability, interoperability, and compliance. The Director of AI will lead the development and implementation of AI strategies to enhance clinical development processes. This role is responsible for architecting scalable AI solutions, guiding technical execution, and driving innovation across EDETEK’s AI product portfolio. The ideal candidate will have deep expertise in AI and clinical development for life sciences companies, with a strong background in machine learning, data science, and enterprise AI systems. This role requires a dynamic leader who thrives in a fast-paced, startup-like environment and can translate business goals into impactful AI solutions. Essential Functions and Responsibilities 1. AI Strategy & Leadership • Define and execute the AI vision aligned with EDETEK’s strategic goals., • Lead cross-functional teams to deliver AI-driven capabilities across clinical development., • Provide technical leadership and mentorship across the AI engineering team., • Inform and deliver on ambitious product roadmaps to accelerate growth. 2. AI Architecture & Development • Architect and build scalable AI infrastructure and solutions to support business growth., • Oversee model training, optimization, and deployment of end-to-end ML models., • Define best practices for AI/ML lifecycle management and governance., • Ensure compliance with industry standards and regulatory frameworks. 3. Collaboration & Stakeholder Engagement • Collaborate with stakeholders to translate business goals into technical solutions., • Partner with engineering, product, and clinical teams to integrate AI into platform capabilities., • Communicate AI strategy and progress to executive leadership and external partners. 4. Innovation & Technical Execution • Lead initiatives in advanced AI domains including transfer learning, generative models, and reinforcement learning., • Drive the development of enterprise knowledge management systems, NLP frameworks, and semantic data integration., • Master’s degree in Engineering, Computer Science, or a related quantitative field; advanced degree preferred., • 6+ years of hands-on experience in clinical trials and clinical development., • 3+ years of experience building and deploying AI/ML solutions and products., • Strong background in AI/ML fundamentals and software development., • Experience with modern databases, cloud environments, and data ecosystems., • Proven success in leading large-scale projects with multiple stakeholders., • Ability to thrive in a startup-mode environment and manage change effectively., • Excellent communication and interpersonal skills. Preferred Qualifications, • Expertise in transfer learning, unsupervised feature generation, meta-learning, generative text models, reinforcement learning, and Agentic AI., • Proficient in deep programming and production-grade AI implementation., • Experience designing enterprise knowledge systems, semantic web frameworks (RDF, OWL, SPARQL), and healthcare classification systems (SNOMED CT, CDISC, MeSH)., • Advanced data science and mathematical skills (e.g., PhD in computational modeling, machine learning, statistics, computer science). Why Join EDETEK?, • Opportunity to lead and innovate in a dynamic and growing company., • Collaborative and inclusive work environment., • Competitive salary and benefits package. Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees. • Choice of comprehensive Medical, Vision and Dental Insurance plans, • Paid vacation time and sick days, • Corporate holidays annually, • Participation in the 401K Plan, • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.

Job 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 Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: We are seeking a Counsel, Contracts and Legal Affairs (Director level) to join our legal team and lead high impact contracting matters across R&D, commercial operations, market access and G&A functions as we prepare to launch our first commercial product. This is a hands-on role for an experienced in house attorney who enjoys ownership, cross functional partnership, and operating in a fast moving, scaling organization. Location: Hybrid in NYC/NJ. Reports to: VP, Associate General Counsel. Roles and responsibilities (Include but are not limited to): • Draft, review, and negotiation of complex R&D and clinical development agreements, including:, • Clinical trial agreements (CTAs), • CRO, CDMO, and other strategic vendor agreements, • Research collaboration and services agreements, • Draft, review, and negotiation of commercial contracting agreements, including:, • Commercial vendor and services agreements, • Supply, manufacturing, distribution, and logistics agreements, • Support negotiation of payer and market access agreements, including managed care, reimbursement, and innovative contracting models (where applicable), • Advise business partners on contractual risk, deal structure, and practical solutions aligned with company strategy, • Help build and scale contracting processes, templates, and negotiation playbooks, • JD from an accredited law school and active bar membership in at least one U.S. jurisdiction, • Typically 3-5+ years of legal experience, with meaningful in house experience in the pharmaceutical or biotechnology industry strongly preferred or relevant law firm experience supporting life sciences clients, with exposure to in-house-style responsibilities, • Significant experience negotiating:, • R&D and clinical development contracts, • Commercial vendor and operational agreements, • Payer or market access–related agreements, • Other vendor agreements, • Strong understanding of the legal and compliance considerations facing emerging commercial-stage life sciences companies, • Proven ability to lead matters independently and exercise sound judgment, • Business oriented mindset with excellent communication and stakeholder management skills, • The ideal candidate should have the following characteristics:, • Legal smarts, analytic rigor, business sense, and a strong work ethic;, • Ability to operate independently and work cross functionally with various teams across the organization;, • Excellent interpersonal communication skills and exemplary attention to detail;, • Likes finding solutions to complex problems and works well under pressure;, • Strong written and oral communication (including analysis, interpretation, & reasoning) and organizational skills (project management);, • Flexible, with excellent ability to manage multiple projects simultaneously; and, • Experience supporting a clinical to commercial transition or first product launch, • Exposure to market access, reimbursement, or payer contracting strategy, • Play a leadership role at a company approaching a major commercialization milestone, • Work closely with senior stakeholders across development and commercial team Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$200,000—$260,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Jefferies Global Healthcare Group provides comprehensive advisory and capital markets services across healthcare services, biotechnology, pharmaceuticals, medical technology, tools and diagnostics, and healthcare technology. The ideal candidate will be a first- or second-year Vice President with pri

Top investment bank seeking an equity research associate to support a rising senior biotechnology analyst covering mid- and small-cap biotech companies. Conducting proprietary research and evaluating drug pipelines by analyzing scientific literature, attending medical conferences, and consulting ind

The Global Healthcare group provides advice and services across a wide range of sub-sectors, including: Biotechnology, Diagnostics / Life Sciences, Healthcare Information Technology, Healthcare Services, Medical Devices, and Pharmaceuticals. Significant experience in Healthcare sector within the pri

The Global Healthcare group provides advice and services across a wide range of sub-sectors, including: Biotechnology, Diagnostics / Life Sciences, Healthcare Information Technology, Healthcare Services, Medical Devices, and Pharmaceuticals. Significant experience in Healthcare sector within the pri

Jefferies Global Healthcare Group provides comprehensive advisory and capital markets services across healthcare services, biotechnology, pharmaceuticals, medical technology, tools and diagnostics, and healthcare technology. The ideal candidate will be a first- or second-year Associate with prior he

Our uniquely positioned and nationally recognized technology transactions team partners with some of the most innovative and exciting life sciences companies, including biotechnology, pharmaceutical, medical device, digital health, diagnostic, and discovery tools. Demonstrate familiarity with and in

Inizio Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses.To deliver educational support to identified patients, Healthcare Professionals and to other office staff within primary care and specialist facilit

A clinical-stage biotechnology company is seeking an experienced Executive Assistant for its R&D team in New York.The role involves supporting the Chief R&D Officer and Chief Medical Officer with administrative tasks and communication management, requiring strong organizational skills and a proactiv

Inizio Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses.To deliver educational support to identified patients, Healthcare Professionals and to other office staff within primary care and specialist facilit

Inizio Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses.To deliver educational support to identified patients, Healthcare Professionals and to other office staff within primary care and specialist facilit

A leading biotechnology company is seeking a Medical Science Liaison to support oncology products in New York.The MSL will build relationships with healthcare providers, educate them about product use, and ensure optimal patient outcomes.Candidates should have an advanced degree in a health-related

A leading biotechnology firm is seeking a Medical Science Liaison to enhance collaboration with healthcare professionals in oncology.

A leading global biotechnology firm is seeking a Medical Value and Health Information Technology Manager to engage with healthcare systems and manage EHR-related initiatives. The ideal candidate will possess a Doctorate or relevant experience in the biotechnology or hospital systems, with a backgrou

The hourly rate for the Medical Affairs Summer Internship (PharmD Students - P1 to P2) is : $25. The Medical Affairs Summer Internship provides early exposure to the role of Medical Affairs within a pharmaceutical or biotechnology organization. The duration of the internship is 12 weeks.

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) Manager, REMS plays a key leadership role in the management of our Risk Evaluation and Mitigation Strategies (REMS) Program for COMP360. The REMS manager will work closely with REMS team members to ensure REMS compliance, operational excellence and quality documentation is in place for the program. Location: East Coast, United States (proximity to New York City preferred). Reports to: Sr. Director, Clinical Safety and Pharmacovigilance. Role and Responsibilities: (include but not limited to) • Support delivery of REMS activities to agreed timelines according to company quality standards and REMS procedures., • Conduct reconciliation of various REMS data sources including compliance data, shipment data, Key performance indicator data to ensure proper oversight and compliance of the REMS program, • Manage the REMS shared mailbox, respond to REMS queries and triage questions/issues as needed for resolution amongst REMS team members, • Manage REMS specific issues and escalations, as applicable, • Coordinate regular team meetings; track outstanding action items and activities per the project plan, • Help manage and reconcile contracts, POs and invoices, • Support REMS processes and procedures with execution of key deliverables Candidate Profile: • Bachelor's degree (preferably in medical or biological science) or equivalent by experience, • Relevant clinical/medical experience in the pharmaceutical industry, with experience in pharmacovigilance and/or quality assurance, • Previous demonstration of basic project management skills including tracking deliverables, • Prior REMS experience, • Strong communication skills and fluency in English, • Prior experience tracking metrics and/or compliance and safety data including trending and interpreting data, • Detail oriented and, • Proficient in Microsoft applications, • Broad knowledge and understanding of FDA regulations and compliance requirements in a GxP environment, • Project Management Certification a plus, • Audit or Inspection experience Working with third-party vendors advantageous, • Aligned to our values and mission 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$130,000—$180,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job DescriptionCompany Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Summer Fridays, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description The Clinical Account Manager (CAM) acts as the primary customer contact for sales demand creation by executing marketing strategy and promoting Sobi products as lead by the Regional Sales Director. In this strategic role, the CAM provides current and comprehensive clinical knowledge of Sobi’s products and effectively communicates the on-label clinical benefits of the products. As a sales leader, the CAM is expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages to customers, representing Sobi at local meetings, and achieving or exceeding sales targets. *Please note this is a remote position but candidate must reside within the territory (New York North) • Responsible for representing Sobi’s products and services to a defined customer base, generating and growing sales and consistently achieving or exceeding sales goals within a specific geographic area and actively promotes the appropriate use of Sobi products to healthcare professionals in accordance with all Corporate, PhRMA, and OIG guidelines, • Comprehensive understand of Sobi and competitor products in their therapeutic area, and an in-depth knowledge of the disease states., • Develops and implements a territory business plan to meet customer needs and achieve sales goals and weekly analysis of territory sales data to help prioritize physician targeting and ensure accurate reporting of physicians, • Strict compliance with all regulatory agencies, state, and federal law is required., • Prepares territory budget plans for customer contacts, local symposia, and other miscellaneous external expenditures, • Assists in the identification and resolution of issues and opportunities and communicates proactively to sales and marketing management., • Reports all adverse events to Sobi’s Drug Safety department as appropriate per required guidelines, • Performs all administrative functions require of the position, including reporting call activity and customer information into the appropriate call reporting system in a timely manner, submitting expenses, etc.Qualifications, • Located within the territory, • BA/BS in business or science, • Minimum of 5 years’ with dedicated hospital selling experience in the Pharmaceutical or Biotechnology industry, with minimum of 3 years’ specialty sales experience in the Pharmaceutical or Biotechnology industry, • A CAM will have a minimum of 3 years’ of biologics sales experience that will utilize a specialty pharmacy or 8 years with dedicated hospital selling experience. Experience with a transition of care/patient journey process from the hospital to the outpatient setting, • Demonstrated history of high sales performance, • Experience with single source pharmacies, reimbursement programs, managed care, and formulary, • Strong work ethic, ability to develop priorities, and manage time appropriately in a large, assigned geography., • Travel within the assigned territory, including overnights, which could be as high as 40-50% in some cases. Must be based in, or located near given geographic territory (relocation will not be provided), • This individual will also be responsible for accurately performing all administrative functions require of the position, including reporting call activity and customer information into the appropriate call reporting system in a timely manner, submitting expenses, etc., and travel within the assigned territory, including overnights, which could be as high as 40-50% in some cases. Must be based in or located in close proximity to given geographic territory (relocation will not be provided). Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: • A competitive 401(k) match to support your financial future., • Tuition and wellness reimbursements to invest in your personal and professional growth., • A comprehensive medical, dental, and vision package to prioritize your health and well-being. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to Know Your Rights

Job DescriptionManufacturing Associate II Allendale, NJ Lynkx Staffing specializes in placing Biotechnology, Pharmaceutical, Medical Devices, IT & Human Resources professionals in New Jersey. Under the supervision of the Associate Manager, the Manufacturing Associate II processes, cultures, cryopreserves and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP and GMP practices. Facility and personnel specific responsibilities will be regulated by company's policies or client procedures being performed at each Cellular Production Facility. The ideal candidate must have a collaborative and inquisitive nature, must possess excellent organizational and verbal and written communication skills and be flexible in their working hours. • Performs any and all required processing and manipulation required to produce and assess safe and efficacious products, • Proficiently functions within an ISO Class 7 and 6 clean room environments, ensuring personal and product safety, • Consistently produce a high level of documentation accuracy and clarity, • Performs cryopreservation of products using DMSO base solutions and controlled-rate freezers, • Proficiently operate and maintain equipment according to designed procedures. Assigned responsibilities could include but is not limited to COBE 2991 cell washer, Clinimacs cell separator, Elultra cell separator, controlled- rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipets, wave bioreactors, refrigerators, ultra- cold freezers, water baths, tube sealers, dry shippers, centrifuges, sterile connection devices, • Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints, • Participating in clinical trial support and studies, may include but not limited to sample preparation, sample shipping, media and reagent preparation., • Thawing and/or washing cryopreserved hematopoietic cell products either at the Clinical Site or in the facility as specified by standard operating procedures, • Performing facility and equipment duties such as periodic maintenance, preventive maintenance, for applicable methods and equipment, reporting facility and equipment problems to Assistance Manager, trouble-shooting facility and equipment problems as specified in standard operating procedures, • Notifying Management of any deviation that may occur during processing or during equipment maintenance., • Applies knowledge of processing principles and techniques to make good judgement and appropriate decisions, • Performs investigations for deviations and complete deviations and CAPA’s (Corrective and Preventive Actions) in a timely manner, • Supports technology transfers into GMP manufacturing operations, • Participate in the on-call programREQUIREMENTS, • BA/BS or Associate's Degree in a biologics or related field preferred, • 2-4 + years of applicable experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing, • Current Medical Technologist license or equivalent is a plus, • Aseptic/cell processing and clean room experience preferred, • Demonstrates tact and courtesy in dealing with others, • Strong work ethic, methodical approach to new challenges, • GLP and GMP experience a plus, • Must be able to work independently and with minimal supervision, • Able to work in fast paced environment at times under pressure and with tight deadlines, • Excellent organizational skills and attention to detail, • Good verbal and written communication skills, • Strong team-oriented interpersonal skills are essential, • 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, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work a flexible schedule that may include nights, weekends and/or holidays, • Training Required; GMP, Gowning training/qualification, Aseptic process qualification (personal media fill), • 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 companyWorking EnvironmentMay 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, and liquid nitrogenMust have the ability to work in the cleanroom environment for extended period of timeMust have the ability to work with specialized equipmentMust 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 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.

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

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

Job DescriptionPatent Agent – Life SciencesLocations Boca Raton, Florida; Boston, Massachusetts; Greenwich, Connecticut; Hartford, Connecticut; Miami, Florida; New Haven, Connecticut; New Jersey; New York, New York; Providence, Rhode Island; Stamford, Connecticut; Washington, DC; West Hartford, Connecticut; West Palm Beach, Florida Direct Counsel is seeking a Patent Agent to join the Intellectual Property practice of a sophisticated East Coast–based law firm. This is an outstanding opportunity for a Patent Agent with 4+ years of experience to join a growing IP team supporting sophisticated life sciences, biotechnology, pharmaceutical, and medical device innovations. The role offers broad exposure to patent drafting, prosecution, portfolio strategy, and IP diligence, working closely with attorneys, inventors, and business teams across multiple disciplines. Position Overview The ideal candidate will have at least 4 years of patent drafting and prosecution experience, with a strong focus on life sciences technologies, including biotechnology, pharmaceuticals, and medical devices. This role is ideal for a technically sophisticated Patent Agent who enjoys translating complex scientific innovations into strong patent protection strategies and who wants meaningful involvement in portfolio management, diligence, and long-term IP counseling. The firm offers a hybrid schedule with two remote days per week. Key Responsibilities • Evaluate the patentability of innovations across life sciences and related technology areas, • Prepare, draft, and file U.S. patent applications, • Manage and prosecute U.S. patent applications, • Coordinate with foreign counsel on international prosecution, • Support IP due diligence and freedom-to-operate analyses, • Assist with strategic patent portfolio development and management, • Conduct legal and technical research using:, • SciFinder, • USPTO, • WIPO, • EPO, • Other scientific and patent databases, • Collaborate with attorneys, inventors, scientists, and business teams on IP strategy, • Support interdepartmental IP initiatives and outside counsel coordinationQualifications, • Minimum 4 years of patent drafting and prosecution experience, • Experience in a law firm or in-house setting, • Strong focus on:, • Biotechnology, • Pharmaceuticals, • Medical devices, • Life sciences innovations, • Ph.D. in a relevant life sciences discipline required, • USPTO registration required, or eligibility to sit for the Patent Bar in the near term, • Strong experience using patent and scientific search tools/databases, • Ability to connect detailed scientific research with patentability and claim strategy, • Excellent organizational skills and deadline management, • Strong written and verbal communication skills Compensation will vary based on office location, experience, scientific background, and overall fit. Ideal Candidate The ideal Patent Agent will be: • Deeply technical with strong life sciences fluency, • A polished patent drafter and strategist, • Comfortable working directly with inventors and R&D teams, • Interested in portfolio counseling beyond routine prosecution, • Highly organized and deadline-driven

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

Job Description 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 Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Production Technician I is responsible for the aseptic manufacturing of Cresilon’s products for the animal health industry. The Production Technician II will be trained in clean room operations, aseptic techniques, and must demonstrate the ability to successfully pass gowning qualifications. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will have a proven track record of steady progress in a similar manufacturing environment and must possess a willingness to learn all equipment and jobs in the assigned manufacturing and sanitation of clean room facilities as required. Production Technicians are also responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP). • Perform line clearance of assigned production areas as required., • Perform equipment set up and disassembly activities., • Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling equipment, and packaging equipment., • Formulate, fill, and pouch product in accordance with SOPs., • Troubleshoot all operating deviations and issues and coordinate with other functions when required., • Report both machine and operating deviations to area supervisor or designee., • Perform routine, preventative maintenance on equipment., • Perform cleaning and disinfection of the manufacturing spaces., • Perform cleaning and sterilization of manufacturing equipment., • Perform visual inspection of components and/or product in accordance with SOP’s and cGMP’s., • Perform sampling, intermediate, and finished goods packaging as per SOPs., • Package and ship raw materials for sterilization., • Perform material receiving, staging, material movements, and material replenishment as per SOPs., • Transport samples, materials, and equipment between multiple facilities., • Complete data entry and generate reports for material inventory movements., • Complete and maintain applicable logbooks and batch record paperwork as required and in accordance with GMP and GDP standards., • Maintain a clean production environment during shift., • Report all actual, near misses and potential accidents for further investigation., • Take immediate action to resolve any near miss situations., • Assist in investigation of all actual, near misses and potential accidents. Provide information to troubleshoot and take initiative to resolve operational issues independently., • Assist in project commissioning and validation activities, as necessary., • Prepare samples or prototypes as required for testing, or other evaluations, • Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process., • Complete all required trainings: Read and Understand (TM1), Computer Based Training with Quiz (TM2), Instructor Led (TM3/TM4), and On-the-Job Trainings (TM5)., • Oversee training of junior employees on production processes as assigned., • Ensure proper communication and handling over of shift duties., • Support Environmental and Personnel Monitoring (EM/PM) activities as directed., • HS Diploma or Equivalent with 2+ years of relevant manufacturing experience in the pharmaceutical, biotechnology, or medical device industry OR 2 or 4 year degree with 0+ years of relevant experience., • Ability to read, understand, and execute written work instructions., • Ability to complete documentation accurately., • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals, • Ability to become gowning qualified to work in a cleanroom environment., • Ability to problem solve and achieve business objectives., • Ability to adapt training approach., • Willingness to be flexible, and open minded to new processes or changes in direction., • Team oriented, building relationships with peers and managers in a proactive manner., • Excellent verbal and written communication skills., • Proficient in Microsoft Office (Word, Excel, Outlook)., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Monthly MetroCard Reimbursement This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description 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.

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Equity Research Associate - Biotechnology. Equity Research Associate - Biotechnology, Jefferies, New York, NY. Conducting proprietary research evaluating drug pipelines by analyzing scientific literature, attending medical conferences, and speaking with key opinion leaders.

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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.

Equity Research Associate - Biotechnology, Jefferies, New York, NY Responsibilities: Conducting proprietary research evaluating drug pipelines by analyzing scientific literature, attending medical conferences, and speaking with key opinion leaders Building and maintaining financial models Writing re

Equity Research Associate - Biotechnology, Jefferies, New York, NY Responsibilities: Conducting proprietary research evaluating drug pipelines by analyzing scientific literature, attending medical conferences, and speaking with key opinion leaders Building and maintaining financial models Writing re

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(s), National Account Management are each accountable for building and leading a national payer Account Director team, responsible for driving formulary access and coverage for COMP360 across national and regional payers and PBMs: • One team will focus on Commercial and Medicare Location: Remote in the United States. Reports to: Senior Director, National Account Management Roles and responsibilities (Include but are not limited to): National Payer Account Strategy and Execution • Work closely with the Senior Director to develop and execute national account strategies across respective payer segments to drive optimal formulary positioning for COMP360 at launch, • Stay current with dynamic market forces, customer organizational changes, and federal and state policies, that impact Compass and/or payer customers, and incorporate those variables into proposed account strategies as necessary and appropriate, • Lead account-level planning and prioritization by their team, profiling key payer decision-makers including Pharmacy Directors, Medical Directors, Clinical Pharmacy and Finance leads, and P&T committee members, • Establish and own strategic relationships with national and regional payer accounts, as part of leading their team to be the primary interface for coverage, contracting, and access discussions, • Articulate the clinical and economic value proposition of COMP360 to payer audiences, integrating HEOR evidence, budget impact models, and real-world data to support coverage and access decisions, • Partner with the Senior Director, National Account Management on pricing and contracting strategy, ensuring payer proposals are commercially sound and aligned with government pricing compliance requirements, • Partner closely with HEOR, Medical Affairs, Government Affairs, and Commercial Operations to align account strategies with the broader market access and commercial framework, • Collaborate with Commercial Operations on field-facing payer communication tools, formulary grids, and access updates that enable effective Sales execution, • Build and lead a high-performing national Account Director team responsible for securing coverage by payers and PBMs within their respective payer segments (noted above under "Job overview"), • 10+ years in pharma/biotech Market Access, with significant direct experience and demonstrated success working with large national payers across Commercial, Medicare, Medicaid, VA, and/or DoD segments, • 5+ years leading a team of national Payer Account Directors, • Demonstrated success securing access for launch-stage specialty or breakthrough products; CNS/psychiatry or novel treatment modality experience a strong plus, • Proven track record negotiating, securing, and maintaining access for products covered by pharmacy benefit and medical benefit, • Innovative payer contracting experience (e.g. Outcomes based, value based etc.), • Deep knowledge of US payer landscape, formulary decision-making processes, utilization management, and prior authorization design, • Ability to translate HEOR and health economic data into compelling value narratives for payer audiences, • Hands-on launch experience at a growth-stage biotech; comfortable building function infrastructure including processes, tools, and teams from scratch, • Exceptional stakeholder management skills; equally credible with external payer accounts and internal cross-functional partners, • Bachelor's degree required; advanced degree in Business, Public Health, Health Economics, or Pharmacy preferred Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$260,000—$290,000 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: The Director, Promotional Medical Education owns the end-to-end promotional medical education function, setting strategy and long-term vision while also personally leading execution of education programs (and overseeing TLL operationalizing programs regionally, where appropriate). This role establishes an integrated promotional education roadmap aligned to company objectives and customer needs, builds and operates a compliant speaker/faculty model, and delivers high-quality educational experiences through live, virtual, and hybrid formats. The Director will be both strategic architect and operational driver, ensuring education investments translate into measurable engagement and impact. Location: Hybrid in our New York City office or remote on the East Coast in the United States. Reports to: Senior Director, HCP Marketing. Roles and responsibilities (Include but are not limited to): Strategy, Vision & Portfolio Leadership • Own the multi-year promotional medical education strategy and roadmap, translating company priorities into scalable education plans and platforms, • Set portfolio-level priorities across channels, programs, audiences, and investments, balancing near-term execution with long-term capability building, • Serve as a strategic advisor to cross-functional leadership, positioning promotional education as a core business and customer engagement driver, • Architect and build integrated promotional education experiences (e.g., peer‑to‑peer programs, workshops, advisory boards, speaker trainings, congress symposia/product theaters where applicable, and digital learning), • Lead content planning with internal stakeholders (Brand, Medical Affairs, Marketing) to ensure alignment with strategy and educational objectives, • Set the promotional speaker/faculty strategy and operating model, including recruitment profiles, onboarding/training approach, utilization, governance, and ongoing capability building, • Lead end‑to‑end execution of promotional medical education programs, ensuring operational excellence across live, virtual, and hybrid formats, • Implement efficient, scalable processes that support speed, quality, and compliance, • Shape the organization's promotional education‑driven engagement philosophy; how, when, and where to engage customers through educational channels, • Partner closely with cross‑functional teams (Commercial, Medical Affairs, Field Teams, Marketing, Market Access) to align priorities and deliver cohesive customer experiences, • Define a measurement framework linking promotional education to engagement quality and business objectives, • Bachelor's degree required (life sciences or related field preferred); advanced degree a plus, • 8+ years of experience in medical, professional, or promotional education, HCP education, training, or related roles, • Proven ability to lead both strategy and hands on execution of education programs across live, virtual, and hybrid formats, • Strong knowledge of FDA promotional regulations and applicable education compliance standards (promotional and non promotional), • Experience supporting product launches, lifecycle management and building speaker/faculty models, • Experience leading teams and/or managing vendors as an extension of the organization, • Experience with digital education platforms and innovative learning approaches, • Demonstrated ability to develop and communicate strategy with senior leaders in matrixed environments, • Strong leadership, influence, and stakeholder management skills, • Highly organized, execution focused, and able to manage complexity and change, • Track record of delivering high quality work on time and on budget Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$200,000—$250,000 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: The Senior Manager, Creative will lead the development of compliant, impactful creative assets that bring our scientific story and patient mission to life across all channels. Starting part-time, this role will scale to full-time as we approach key milestones, partnering with cross-functional teams to ensure brand consistency and excellence. Location: Hybrid In our New York City office or remote In the East Coast, United States. Reports to: VP, Communications. Duration: Part-time (20 hours/week) for the first 6 months; potential to increase to full-time (40 hours/week) for the remainder of the contract (ending at the end of the year). Roles and responsibilities (Include but are not limited to): • Lead the development of an integrated creative strategy that brings our brand, scientific narrative, and patient mission to life across all key channels (digital, social, web, events, and internal communications), • Translate complex scientific and clinical concepts into clear, compelling creative ideas, ensuring all assets are accurate, compliant and accessible for diverse audiences, including HCPs, payers, patients, and caregivers, • Own the end-to-end creative process from brief to delivery, including concepting, storyboarding, copy and visual direction, feedback cycles, and final approval in partnership with Medical, Legal, and Regulatory stakeholders, • Partner closely with Brand, Marketing, Medical Affairs, Market Access, and Corporate Communications to ensure creative work is aligned to corporate brand strategy, • Build and maintain a best-in-class asset library and design system (templates, guidelines, toolkits), enabling consistent execution across in-house teams and external agencies, • Use insights and performance data from digital, social, and campaign analytics to iterate and optimise creative concepts, formats, and messaging over time, • Champion inclusive, stigma-free storytelling that reflects diverse patient experiences and supports our vision for mental wellbeing; act as a guardian of tone of voice and visual identity across touchpoints, • 8+ years in senior creative/brand roles, ideally biotech/pharma, • Proven integrated creative campaigns (digital, social, experiential), • Translates science into compliant, emotive visuals/narratives, • Strong portfolio; stewards brand guidelines/design systems, • Cross-functional collaborator (Medical, Legal, Commercial), • Expert in multitude of design tools and platforms, • Data-informed; optimizes via analytics 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】:$130,000—$190,000 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: The Senior Financial Analyst, Commercial delivers critical FP&A support to Commercial OPEX budget owners, handling budgeting, quarterly forecasts, long-range planning, and detailed budget vs. actuals at department, account, and PO levels. Builds and maintains OPEX forecast models for hub/patient services, T&E, and headcount; partners on business cases, PO approvals, spend risks/opportunities, SOX compliance, and Accounting alignment. Drives process improvements, executive presentations, and cross-functional partnering in a fast-paced, pre-launch biotech environment advancing mental health treatments. Highly preferred to have prior biotech/pharma experience. Location: Hybrid in New York City office. Must be commutable to NYC office or northern NJ office at least 1-2 days/week. Reporting to: Associate Director, FP&A. Roles and responsibilities: (include but not limited to) • Provide FP&A support to Commercial OPEX budget owners budget, quarterly forecast and long range planning submissions, • Prepare detailed budget vs actuals at the relevant level of analysis (dept level, account level, purchase order level etc) for review with Commercial budget owners, • Create and maintain OPEX forecast models for Commercial related activities, including hub/patient services, T&E analysis etc, • Partner with Commercial leadership and the People Team to understand headcount requests, timing and all associated expenses (benefits, recruiting, sign-ons etc), • Support business plan development for potential Commercial OPEX investments, • Partner with Commercial OPEX budget owners to ensure purchase orders are created and approved with accurate coding and in accordance with our delegation of authority, • Proactively identify spending risks and opportunities through interactions with and escalate to FP&A/Commercial leadership when appropriate, • Partner closely with broader FP&A team for corporate / SOX deliverables, • Partner with Accounting to ensure accurate reflection of actuals and to ensure alignment of expense and cash forecasts according to accounting treatment, • Input relevant data into Powerpoint presentations for Commercial, Executive and Board level leadership, • Bachelors Degree in Finance or Accounting, • 3-5 years FP&A experience in a public company, • Pharma/biotech experience, • Commercial experience is a plus, • Expertise with Excel and strong PowerPoint skills, • Prior experience with Workday Adaptive (or similar) and Netsuite (or similar) financial software, • Detail oriented with strong analytical skills, • Ability to perform in a fast moving, pre-launch environment, • Team player with a customer service approach to business partnering 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】:$120,000—$170,000 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.