Director, Peptide Process Development

Responsibilities

• Lead process development, optimization, scale up, and characterization of peptides and contribute to the development of peptide oligonucleotide conjugate (POC) APIs with internal stakeholders.
• Serve as the technical lead for peptide and POC processes from development through external GMP manufacture.
• Evaluate, select, and enable CDMOs; lead process transfer and external manufacturing activities.
• Author and review technical and regulatory documentation supporting API manufacture and filings.
• Integrate CMC process activities within TOQ and extended program teams.
• Contribute to long-term peptide and POC platform strategy and delivery.

Qualifications

• PhD in a relevant scientific discipline with 10+ years of industry experience in peptide and/or conjugate process development.
• Demonstrated expertise in peptide API development, scale up, and process characterization.
• Experience in process development, optimization, scale-up, and process characterization of peptide-drug conjugates and/or oligonucleotide conjugates.
• Proven experience leading process transfer and external CDMO-based GMP manufacturing.
• Experience supporting CMC documentation and regulatory filings.
• Ability to function as a technical owner within cross-functional program teams.

Pay

$197,100.00 - $266,700.00

Schedule

Onsite in Cambridge, MA