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.
Benefits (as listed):
- Annual short-term incentive award (e.g., bonus or sales incentive) and annual long-term incentive award (e.g., equity).
- Medical, dental, vision; life and disability insurance; lifestyle reimbursement; flexible spending/health savings accounts; 401(k) with generous match; paid time off, wellness days, holidays, and two recharge breaks.