We are seeking an experienced and motivated Senior Scientist for our Drug Substance Development group to help with the CMC Peptide development strategy. This individual will work closely with Peptide Contract Manufacturing and Testing Organizations to support the advancement of personalized medicine approaches for the prevention and treatment of diseases with significant impacts on human health. This position requires excellent technical, leadership, organizational, communication, negotiating and interpersonal skills.
Be a primary contributor to our Peptide Chemistry team, working in the personalized medicine arena.
Develop peptide drug substance strategy for QC testing and release
Act as principal lead for technical and scientific interactions with Contract Testing and Manufacturing Organizations (CMOs)
Review batch records and analyze analytical data to make key decisions regarding lot release and CoA generation while closely working with Quality Assurance (QA)
Identify and engage CMOs with support from technical team leads
Assist in analytical oversight of process validation planning, coordination and execution.
Assist in the successfully initiating and managing 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 with 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
Education & Experience Required
Master’s or Ph.D. in Life Sciences, with a minimum of 5 years of industry experience in Solid Phase Peptide Synthesis (SPPS), peptide chemistry and analysis of peptides via UPLC and MS
Experience working with contract testing laboratories, and contract manufacturers
Mass spectrophotometry experience in LCMS/MS of peptides is also a plus
Demonstrated track record of success in delivering on clinical supply
Strong knowledge of global cGMPs
Experience in Personalized Medicine therapeutic area