Director/Assoc. Director, Analytical Development for QC

Vaxcyte is looking for an energetic and talented individual to join Vaxcyte's Vaccine Product Development organization as an Associate Director / Director within Analytical Development Quality Control department. The primary function of this Director level position is to lead the analytical development for all products in preclinical and clinical development. This position reports directly to the Senior Director of Analytical Development and QC (AD & QC). The successful candidate will also manage and grow a group of staff from senior scientists to research associates, and provide scientific mentorship and technical guidance to members of AD & QC department.

Essential Functions:

• Provide strategic, tactical and technical leadership for Analytical Development and QC

• Take on end-to-end strategic responsibility for analytical method development of intermediates, drug substance and drug products.

• Direct method development for quality control and stability testing of proteins, bacterial polysaccharides, and polysaccharide-protein conjugates, and adjuvanted vaccines (vaccines or biologics experience not required)

• Take on end-to-end responsibility of method development for GMP lot release and stability testing of proteins, bacterial polysaccharides, polysaccharide-protein conjugates, and adjuvanted vaccines product. Responsibility also includes resource planning, team productivity and timeline management of the deliverables.

• Drive analytical innovation and stay on top of cutting edge analytical technology. Introduce and establish novel technology in house if necessary.

• Provide technical direction, mentorship and coaching to the analytical development team

• Manage performance and development of personnel to ensure achievement of organizational and department goals

• Cultivate a cohesive, innovative, nimble and productive team environment

• Support Associate Director of QC for GMP analytical method transfer and validation at the CMOs, as well as trouble shooting of QC testing or method related issue

• Design stability studies of critical material, intermediates, and drug substance and drug product of company's conjugate vaccine projects. This will include R&D stability studies to support process development, toxicology nonclinical studies, or GMP clinical studies.

• Support stability team on data trending, and stability investigation

• Collaborate with Formulation, Process Development and Conjugation to design and develop phase appropriate analytical methods for in-process control and GMP quality control purpose.

• Author multiple regulatory submission and address health authority questions during various clinical phases

• Evaluate and establish contracts with CDMO/CROs for method development and GMP testing or stability studies

• Manage relationships with CDMOs, including managing timelines and cost for the analytical method and GMP testing.

• Provide appropriate CRO/CDMO oversight by reviewing analytical method development data, reviewing and approving analytical method development report, method validation protocols, reports, and analytical method SOPs

Requirements:

• PhD in Chemistry, Analytical Chemistry, Organic or Biochemistry, with 10+ years relevant industry experience; MS or BS with 15+ years of industry experience in Pharma / Biotech industry required

• Must be a team player, strong critical thinker, exhibit a willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines

• Ideal candidate will have proven track record of heading analytical development function and leading teams while managing multiple projects, experience building team and lab is highly desirable

• Strong understanding of various analytical chemistry methodology principles and successful record of method development, trouble shooting and validation for GMP release and stability testing.

• Proven track record of developing polysaccharide, small molecules, protein and conjugate assay methodologies such as content method, purity/impurity method by H/UPLC, capillary electrophoresis, SEC, CEX, icIEF is a must.

• Must possess strong troubleshooting skills under GMP environment

• 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, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy

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

• Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management

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

• Strong attention to detail supported by excellent time management and organizational skills