Sr. Manager / Associate Director, Analytical Development and Quality Control
Posted 2 months ago
Summary of Position:
ArriVent Biopharma is looking for a talented and highly motivated Sr. Manager / Associate Director of Analytical Development and Quality Control. This person will be responsible for managing analytical activities at CROs/CDMOs to ensure generation of high-quality and on-time data for a late-stage small molecule project. The scope of the role spans from release and stability indicating method development, qualification and validation, method transfer, characterization, method trouble shooting, release / stability testing, regulatory filings.
- Manage analytical development activities performed at CROs/CDMOs associated with method development, qualification/validation, transfer and trouble shooting; characterization of drug substance/API, drug product and critical reagents; in-process and in-use stability testing and reference standards qualification.
- Execute strategies for product and process characterization with a focus on product quality assessment, specification, release, stability and comparability studies.
- Collaborate with process, formulation and quality functions to ensure strong cross functional collaborations and integrated process and product development and characterization.
- Author, review and/or approve key source documents for relevant sections of regulatory filings (IND, IMPD, NDA, MAA).
- Assure all documentations and other regulatory compliance systems are maintained according to ArriVent corporate standards.
- Implement processes, technical concept and methodologies to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.
- Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards.
- Provide clear communication to partners and functional line management regarding progress against technical and project objectives/milestones.
Desired Skills and Experiences:
- Advanced knowledge of more than one of the following methods or area: HPLC, GC, mass spectrometry, XRPD, FTIR, TGA, DSC, KF etc.
- Demonstrated ability to effectively collaborate with CRO/CDMO
- Good working knowledge of GMP requirements, including ICH, FDA, and EMA guidelines
- Proven experience with regulatory agency submissions and correspondence
- Late stage and NDA experience is highly desired.
- Experience in biologics analytical development is a plus, but not required.
- Hands-on experience in tech transfer and lifecycle management of methods.
- Proven ability to work with cross-functional teams comprised of internal and/or external contacts.
- Ability to work in a fast-paced, multi-disciplinary and dynamic environment with potential for changing priorities, with flexibility to support multiple development programs simultaneously.
- Ability to drive for results and be innovative
Education & Experience:
- S., M.S. or Ph.D. in chemistry, biochemistry, or chemical engineering or related field
- 5+ years’ experience in pharmaceutical industry with a track record in small molecule analytical method development, method qualification / validation, method transfer, product characterization, reference standard qualification, release / stability testing.