Associate Director, Antibody Development

Overview:

The Associate Director, Antibody Development will lead CMC strategy and execution for antibody and antibody-conjugate programs from sequence handoff through IND and early clinical supply. This role requires strong hands-on experience in cell line development, a solid experience in upstream and, general understanding of downstream process development, and the ability to work closely with analytical, quality, regulatory, and external partners.

This is a hybrid role based primarily in Cambridge, MA.

Responsibilities:

• Lead CDMOs through CHO or other mammalian cell line development activities, including stable pool generation, clone selection, and MCB establishment.
• Provide clear guidance on clone selection strategy, expression systems, and overall development path.
• Work directly with external vendors supporting antibody and antibody-conjugate programs.
• Define clone selection criteria (productivity, product quality, stability) and partner with Discovery/Research to assess developability, manufacturability, expression, and comparability risks.
• Review development reports and batch documentation for upstream activities.
• Oversee cell line development & upstream process development to support tox and GMP campaigns at CRDMOs.
• Build scalability and comparability considerations into early development plans.
• Collaborate closely with analytical and process SMEs to guide method development for potency, purity, aggregates, glycosylation, and product variants.
• Align CMC timelines with overall program milestones and proactively identify technical risks and mitigation plans.
• Ensure documentation readiness for tech transfer and GMP manufacturing.
• Coordinate with Quality and Regulatory to support GMP and IND/CTA readiness.

Qualifications:

• PhD in Molecular Biology, Biochemistry, Chemical Engineering, or related field (MS with significant experience considered).
• Minimum 8years of relevant experience in antibody cell line and process development.
• Direct experience advancing biologics (preferably mAbs or related modalities) into IND/CTA.
• Deep experience with complex or challenging biologics modalities is strongly preferred.
• Strong working knowledge of CDMOs and CROs in the biologics space is required.
• Strong understanding of:
  • CHO cell line development workflows
  • Upstream and downstream process development
  • Analytical characterization of biologics
  • GMP manufacturing and regulatory expectations
• Demonstrated experience managing CDMOs.
• Working knowledge of ICH Q5, Q6, and Q8 principles.

#LI-KB1 #LI-Hybrid

U.S. Pay Range

$161,500.00 - $218,500.00

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 (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

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. 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.