A Leading biotech is looking for a dynamic individual to join their Vaccine Development organization as an Associate Director, QC Stability. If would like to help treat and prevent infectious diseases world-wide by becoming a part of the QC department, read ahead!
What you will do:
- May author multiple regulatory submission and address health authority questions for IND approval
- Support QA organization by evaluating and establishing quality contracts and performing audit of potential CMOs/CTLs
- Manage relationships with existing and new CROs, including managing timelines and cost for the stability studies and reference standards
- Supervise scientists, associates and stability contract sites for implementation of stability activities.
- Author or review and approve all stability study protocols and reports.
- Review and approve all stability study data, deviations, and investigation reports.
- Responsible for stability data trending, statistical analysis, and stability trend limits establishment
- Responsible for setting product expiry based on the stability data analysis and trending
- Collaborate with Formulation, Process Development, Conjugation, and CDMOs/CROs for stability study design, execution, OOS and OOT investigation and expiry labeling
- Lead stability program for all development phase conjugated vaccine projects including end-to-end responsibility of stability related activities for critical raw material, intermediates, and drug substance and drug products
- Independently formulate phase appropriate, risk and science-based stability strategy, and gain cross-functional alignment on the strategies
- Oversee stability studies carried out internally or at our CMOs. This will include R&D stability studies to support process development, toxicology studies, or GMP stability studies.
What they need:
- Ideal candidate will have successful track record of heading company's stability program with the end-to-end responsibilities.
- Strong understanding of various analytical chemistry methodology principles, and track record of validation for GMP release and stability testing, and stability trouble shooting
- Experience in IND, NDA and BLA submission is highly preferred
- Attention to detail and excellent skills in record keeping / documentation
- MS or BS in Chemistry, Analytical Chemistry, Organic or Biochemistry, with 15+ years of industry experience in Pharma / Biotech industry required
- Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation.
- Project management skills including the ability to manage one's project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management