Director/Assoc. Director, Analytical Development for QC
• 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
• 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