Director, CMC Product Development – Biologics

About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

Job Summary

The Director, CMC Product Development – Biologics is a senior technical and operational leader responsible for the end-to-end CMC development of biologics drug product candidates, from early formulation through process development, clinical supply, and regulatory submission. Reporting to the Executive Director, CMC Product Development, this individual drives the drug product development strategy for large molecule programs including monoclonal antibodies, fusion proteins, and other biologic modalities. This role works cross-functionally with Analytical Development, Drug Substance Process Development, Quality, Clinical Operations, and external CDMOs to ensure integrated, timeline-aligned delivery of all biologics drug product CMC activities.

Work Arrangement & Location

Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

Responsibilities

• Define and execute the biologics drug product development strategy, encompassing formulation development, fill-finish process development, primary container-closure selection, and device development where applicable.
• Lead formulation development activities for protein-based therapeutics, including excipient screening, formulation optimization, forced degradation, and compatibility studies.
• Oversee drug product process development and scale-up, including fill-finish requirements, technology transfer to CDMO partners, process characterization, and validation readiness.
• Author and review biologics drug product sections of regulatory submissions (IND, BLA, Type A/B meeting packages) and lead or support FDA/EMA interactions on drug product CMC topics.
• Select and technically govern CDMO partners responsible for biologics drug product manufacture, including clinical supply chain coordination, change control oversight, and deviation management.
• Collaborate with Analytical Development to define drug product release and stability specifications, in-process controls, and comparability strategies for process and formulation changes.
• Partner with Clinical Operations and Supply Chain to ensure uninterrupted clinical supply across Phase 1–3 trials, including labeling, packaging, and cold chain logistics planning.
• Integrate Quality by Design (QbD) principles, Design of Experiments (DoE), and risk management tools into biologics drug product development decisions.
• Evaluate novel drug delivery technologies