Director, Antibody Conjugation Process Development

Alnylam Pharmaceuticals • Cambridge, MA

20h • Onsite

About The Position

The Director, Process Sciences will be responsible for process development, optimization, scale-up and process characterization of antibody oligonucleotide conjugates for platform delivery of oligonucleotide APIs. The candidate will work closely with cross-functional teams and contract manufacturing organizations (CDMOs) on process development, process transfer, and oversight of manufacturing processes.
This position is onsite and will be located at our Kendall Square offices in Cambridge, MA.

Requirements

• Ph.D. in chemistry, chemical engineering, or biochemical engineering with at least 10 years of process research and development experience in the manufacture of antibody drug conjugates.
• Demonstrated proficiency in the design, development, and scale-up of processes for manufacture of antibody-drug conjugates (ADCs).
• Extensive experience in downstream process development, conjugation, purification, and characterization of ADCs including mAbs.
• Hands-on experience with process development and analytical methods for process and product characterization.
• Experience in process transfer and management of contract manufacturing at CDMOs.
• Excellent organizational and communication skills.
• Demonstrated strong operational execution and problem-solving skills.
• Desire to work in a fast-paced, deadline-driven environment.

Nice To Haves

• Demonstrated experience and understanding of analytical methods and techniques as well as upstream process development is a plus.

Responsibilities

• Lead process development, optimization, scale-up, and process characterization of antibody conjugates for platform delivery of oligonucleotide APIs.
• Contribute to the development of long-term strategy for platform delivery programs and provide recommendations to the leadership team.
• Oversee downstream process development and contract manufacturing of antibody oligonucleotide conjugates.
• Author and review technical documentation supporting API manufacture and process characterization activities.
• Accountable for the preparation of the Quality section for regulatory filings and interaction with regulatory authorities.
• Contribute to strategic technical discussions and present progress at internal and external meetings.
• Represent Process Development on cross-functional teams including internal cross-functional program teams and externally with contract manufacturing and/or corporate partners.
• Effectively integrate Process Development activities with other CMC functions in Drug Substance Development & Manufacturing, Analytical Development, Quality Assurance, and Regulatory Affairs.
• Periodic travel to manufacturing and other partner sites is required.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree