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 is accountable for advancing robust, scalable, and regulatory-ready processes from early development through clinical and commercial supply.
This position 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
This position is onsite and will be primarily located in Cambridge, MA.
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.
#LI-KB1 #LI-Onsite
U.S. Pay Range$197,100.00 - $266,700.00The 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 (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
