Associate Director of Stability

Vaxcyte is looking for an energetic and talented individual to join Vaxcyte’s Vaccine Product Development organization as an Associate Director within Quality Control Unit. The primary function of this level position is to lead the stability program for all products in preclinical and clinical development. This position reports directly to the Director of Quality Control.

Essential Functions:

• Lead Vaxcyte’s 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

• 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

• 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.

Requirements:

• 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 for small molecules, biologics and vaccines.

• Demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate strategy

• 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

• Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/shelf life proposals is preferred

• Experience in IND, NDA and BLA submission is highly preferred

• Experience working in a regulated (GLP / GMP) environment

• Attention to detail and excellent skills in record keeping / documentation

• Extensive technical writing experience

• 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

• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats

• Self-starter; ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members