Contract Senior Scientist, Peptide Drug Substance Development

Position Summary

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.

Primary Responsibilities

  • 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 

Required Skills

  • 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

Preferred Experience

  • Strong knowledge of global cGMPs

  • Experience in Personalized Medicine therapeutic area