Director, Peptide Process Development

Overview

The Director of Peptide & Peptide‑Oligonucleotide Conjugate (POC) Process Development will provide technical leadership for the development, scale-up, and external manufacture of peptide and POC active pharmaceutical ingredients. This role requires a balance of hands‑on technical expertise, strong CDMO management experience, and cross‑functional leadership to deliver peptide and POC processes that are fit for development, manufacture, and future scale. The position is onsite and primarily located in Cambridge, MA.

• Lead process development, optimization, scale up, and characterization of peptides and contribute to the development of peptide oligonucleotide conjugate (POC) APIs in collaboration 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.

• 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.

U.S. Pay Range: $ - $. The pay range reflects the full‑time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short‑term incentive award (bonus or sales incentive) and an annual long‑term incentive award (equity).

Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E‑Verify Employer.