Associate Director, CMC Team Lead

Alnylam Pharmaceuticals•Cambridge, MA

56d•Hybrid

About The Position

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.

Requirements

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.
Strong working knowledge of CDMOs and CROs in the biologics space is required.
Strong understanding of: CHO cell line development workflows
Strong understanding of: Upstream and downstream process development
Strong understanding of: Analytical characterization of biologics
Strong understanding of: GMP manufacturing and regulatory expectations
Demonstrated experience managing CDMOs.
Working knowledge of ICH Q5, Q6, and Q8 principles.

Nice To Haves

Deep experience with complex or challenging biologics modalities is strongly preferred.

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.