Associate Director, Biological Raw Material Validation Expert

2 weeks ago

San Carlos, California, United States BioSpace, Inc. Full time
Job Summary

Vaxcyte is seeking an accomplished Associate Director to lead the Biological Raw Material Method Validation and QC team. This role will be responsible for method qualification/validation and overseeing all QC activities in a complex network of Contract Development and Manufacturing Organizations (CDMOs). The successful candidate will have extensive hands-on analytical development and validation experience, with a strong understanding of principles of various analytical technologies used for analysis of biological raw materials.

Key Responsibilities
  • Lead method qualification/validation and oversee all QC activities in a complex network of CDMOs.
  • Collaborate with Analytical Development and interface with key stakeholders to determine when a biological raw material method is suitable for method qualification/validation.
  • Review and evaluate method development data, reports, and documents to be transferred to CMOs, provide technical and compliance feedback to internal and external stakeholders who have developed the analytical methods.
  • Collaborate with CDMOs to design an effective method qualification/validation plan, and lead method qualification/validation activities to ensure campaign readiness.
  • Review and approve biological raw material test methods, method qualification/validation protocols and reports, and responsible for the accuracy and compliance of these documents.
  • Accountable for execution of method implementation, validation, and transfer and responsible for supportive processes including sample planning, scheduling, documentation, compliance/technical review and scientific interpretation of data to ensure the successful validation/qualification/transfer of methods.
  • Responsible for quality event management (deviations, investigations, change control) related to method qualification/validation.
  • Manage outsourced GMP testing at CDMOs.
  • Support audit, inspections, and health authority responses.
  • Guide and work with others to identify opportunities for continuous improvement and implement solutions.
Requirements
  • PhD in Chemistry, Analytical Chemistry, or related field with 7+ years relevant industry experience; MS or BS with 12+ years of industry experience in Pharma/Biotech industry required.
  • Demonstrate sound decision-making skills and exhibit good judgment.
  • Successful track record of analytical method transfer, trouble shooting and validation.
  • Have solid understanding of principles of various analytical technology used for analysis of biological raw materials including DNAs, proteins, and other large molecules.
  • Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements 'best practices' or leading-edge quality standards.
  • Ability to manage project resource requirements (material, manpower, time, etc.), and to elevate relevant issues to analytical lead and line-management.
  • Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
  • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to analytical method qualification/validation for biological raw materials, and retest period.
  • Demonstrate ability of applying regulatory guidance to formulate practical solutions and strategy for phase appropriate analytical method validation and transfer with a focus on biological raw materials.
  • Ability to work globally with CMOs in different countries and continents.
  • Self-starter and resourceful problem solver, and able to move up learning curve independently and map out intermediate milestones to achieve project goals.
  • Experience in IND, NDA and BLA submission is highly preferred.
  • Extensive technical writing experience in drafting analytical method validation and transfer protocols, reports, and method SOPs.
  • Strong interpersonal skills and ability to communicate effectively both verbally and in written formats.
  • Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
Reports to:

Senior Director, Quality Control, Raw Material and Polysaccharide

Location:

San Carlos, CA

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

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