We are seeking an experienced and motivated Principal Scientist for Analytical Development to lead the CMC analytical development strategy and working closely with Contract Manufacturing and Testing Organizations to support the advancement of personalized vaccines for the prevention and treatment of diseases with significant impacts on human health. Applicants should have a Ph.D. with minimum 5 years industry experience in biologics or peptide analytical development with preferably experience working with contract testing laboratories, and contract manufacturers. Experience in vaccine analytical development is preferred. This position requires excellent technical, leadership, organizational, communication, negotiating and interpersonal skills.
- Develop Analytical strategy for analytical development of drug substance and drug product,QC testing and release.
- Act as principal lead for technical and scientific interactions with Contract Testing and Manufacturing Organizations (CMOs)
- Review and analyze analytical data to make key decision regarding lot release and CoA generation while closely working with Quality.
- Identify and engage CMOs with support from technical team leads
- Facilitate due diligence for selection of Contract Testing Labs, including quality audits
- Provide analytical oversight of process validation planning, coordination and execution
- Successfully initiate and manage technology transfer of analytical activities
- Work with QA to facilitate resolution of CMO quality issues (e.g. non-conformances, investigations, CAPAs) and ensure regulatory inspection preparedness
- Collaborate efficiently and effectively across other Pharm Sci & Mfg groups to advance CMC activities
- Contribute to overall CMC strategy development and capacity planning
- Partner with project team members to align analytical development plans with overall project plans
- Support regulatory document development and discussions with regulatory agencies.
- Excellent organizational, management, communication and interpersonal skills.
- Exceptional presentation and writing skills.
- A strong work ethic and sense of purpose
- A demonstrated ability to identify, analyze and solve problems, and working with teams.
- A good balance between being detail-oriented and setting direction/approach
- Mass spectrophotometry experience especially in LCMS/MS of peptides.
Education and Experience Required
- Ph.D. in Life Sciences. Mass Spec. experience.
- 5+ years industry experience in Analytical development. 2+ years experience managing contract testing labs
- Demonstrated track record of success in delivering on clinical supply
- Strong knowledge of global cGMPs
- Vaccines development
- Knowledge of peptide chemistry