Associate Director, Quality Assurance CMC
SCYNEXIS, Inc. (NASDAQ: SCYX) is a publicly traded, clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases. Our pipeline includes two clinical-stage compounds: SCY-770, a novel, highly selective direct AMPK activator in development for autosomal dominant polycystic kidney disease (ADPKD), and SCY-247, a second-generation triterpenoid antifungal candidate currently in clinical stages of development for the treatment and prevention of invasive fungal infections.
Position Summary:
We are seeking a highly experienced, motivated, and innovative quality leader with strong experience across early- and late-stage development to join our team as Associate Director, Quality Assurance (QA-CMC). This position will provide CMC quality leadership within the organization and across our Contract Development and Manufacturing Organizations (CDMOs). This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure SCYNEXIS' clinical and commercial products comply with applicable cGMP requirements and guidelines. The Associate Director, Quality Assurance will be based in our Jersey City, NJ office.
Responsibilities:
- Provide quality leadership, strategy, and compliance oversight of CDMOs, CMOs, CPOs, and third-party vendors. Provide guidance on site- and vendor-related quality issues.
- Provide Quality oversight of protocols, starting materials, finished product specifications, API and drug product manufacturing, and analytical and stability reports.
- Ensure that CMC quality systems, validation activities, product specifications, product release, reference standards, and stability programs are phase-appropriate, effective, and meet standards expected by U.S. and global regulatory authorities.
- Ensure CDMO-manufactured products meet applicable health authority regulations and company standards. Perform quality review of analytical documentation for CMC programs, including method transfer, qualification and validation protocols, in-process controls, data packets, CoAs, and stability protocols/reports.
- Perform batch disposition activities for manufactured clinical products, including review and approval of master batch records (MBRs), executed batch records (EBRs), batch review checklists, and Certificates of Analysis (CoAs); coordinate CoA issuance, as applicable, and document batch release authorization in accordance with established procedures and delegated QA authority.
- Responsible for the management and maintenance of the Veeva QualityDocs system, including drafting, authoring, reviewing, approving, and finalizing internal quality documents (SOPs, WIs, policies, forms, etc.).
- Facilitate GMP/GCP training for functional areas and develop appropriate training for employees and contractors involved in the execution of related duties.
- Perform assessments and QA review of source documents, change controls, deviations, quality events, CAPAs, root cause analyses, product impact assessments, investigations, including OOS investigations, and other reports for accuracy.
- Develop and manage a risk-based Quality Management System for QA in compliance with applicable U.S. regulatory requirements and company policies.
- Participate in the supplier qualification program and provide oversight of contractors and consultants to ensure timely and quality deliverables. Assist in the development, review, approval, maintenance, and management of agreements, including QAAs, MSDs, consulting agreements, and other applicable agreements.
- Work with CMOs to establish and maintain Quality Agreements, address quality issues, ensure quality standards are met, and resolve issues promptly and effectively.
- Support the coordination and management of regulatory agency inspections and inspection-readiness efforts, which may include mock internal inspections and vendor audits.
- Manage inspection commitments, post-inspection activities, and corrective and preventive actions in a timely manner.
Requirements and Preferred Skills:
- B.S. in Biological Sciences, Chemistry, or a related discipline, with a minimum of 10 years of relevant experience in the pharmaceutical/biotechnology industry with increasing levels of responsibility and relevant QA experience, or an equivalent combination of education and experience. The ideal candidate will have extensive CMC experience, including organic and/or analytical chemistry, with significant experience in CMC-QA leadership roles.
- 7+ years of hands-on experience with Quality Management Systems, including electronic document management systems (Veeva preferred), and managing the document lifecycle from draft through approval/effectiveness and periodic review.
- Thorough understanding of U.S. FDA regulatory and compliance requirements.
- Auditor training, experience, or certification.
- Strong understanding of risk assessment and risk management fundamentals and tools.
- Knowledge of FDA, EU, and ICH requirements for GMP and related areas, including 21 CFR Parts 210 and 211, Part 11/Annex 4, and applicable ICH guidance.
- Experience reviewing specifications, MBRs, EBRs, stability protocols, method validation protocols, reports, and related documentation for early- and late-stage drug substance and drug product development.
- Knowledge and understanding of quality management systems, with a focus on batch release requirements for clinical trials and commercial product monitoring.
- Proficiency in creating QMS SOPs and work instructions, with a strong understanding of good documentation practices.
- Experience auditing and qualifying CDMOs.
- Small- or mid-size company experience preferred, with experience leading projects with minimal supervision.
- Proven interpersonal and relationship-building skills, with the ability to work collaboratively as a member of a cross-functional team.
- Excellent organizational skills, attention to detail, and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment, including leading and participating in projects.
- Ability to respond to situations with an appropriate sense of urgency and accountability.
SCYNEXIS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.
The starting pay for this role is between $170,000 and $195,000. The estimated salary range represents an anticipated range for this position. The actual base salary offered may vary based on a variety of factors.
We offer a competitive total rewards package that includes short-term and long-term incentive programs and a comprehensive benefits package, including medical, dental, and vision coverage, a 401(k) with company match, paid time off, and additional benefits.
At SCYNEXIS, we are committed to positively impacting the lives of patients by developing innovative therapies. Join us and help make a difference.
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