Director Process and Analytical Development (Biologics)
Overview
We are seeking a highly skilled Director of Process Development with deep expertise in large‑molecule biologics, antibody analytical development, and CDMO‑oriented process execution. This leader will own the strategy and execution of end‑to‑end process development-from early developability assessments through scalable manufacturing solutions-ensuring robust, high‑quality processes that meet scientific, regulatory, and commercial expectations.
This role is ideal for a scientifically strong, execution‑focused leader who thrives in a dynamic environment and can build, mentor, and scale high‑performing technical teams.
Key Responsibilities
Process Development Leadership
Lead development of end‑to‑end processes for monoclonal antibodies and other large‑molecule biologics, including upstream, downstream, and analytical workflows.
Oversee developability assessments, including expression feasibility, manufacturability risks, aggregation propensity, stability, and sequence liabilities.
Drive scalability testing to enable smooth tech transfer from early development to pilot‑scale and GMP manufacturing environments.
Establish and optimize platform processes, leveraging data‑driven approaches to improve speed, robustness, and reproducibility.
Analytical Development
Guide analytical method development for purity, identity, potency, stability, and product quality attributes (PQAs).
Partner with analytical teams to define critical quality attributes (CQAs) and ensure alignment with regulatory expectations.
Oversee characterization strategies supporting regulatory filings and client‑facing documentation.
Cross‑Functional & External Collaboration
Serve as a scientific and strategic interface with internal stakeholders and external development or manufacturing partners.
Collaborate closely with Protein Engineering, Discovery, Manufacturing, Quality, and Regulatory teams to ensure seamless program execution.
Translate complex technical data into clear, actionable recommendations for diverse audiences.
Team Building & Leadership
Build and mentor a high‑performing team of scientists and engineers across process development, analytical development, and tech transfer.
Foster a culture of innovation, scientific rigor, and operational excellence.
Provide leadership across multiple programs simultaneously, ensuring timelines and deliverables are met.
Qualifications
Required
Advanced degree (PhD preferred) in Biochemistry, Chemical Engineering, Molecular Biology, or a related discipline.
7-15+ years of experience in biologics development, including significant time in a CDMO or biotech/CDMO‑facing environment.
Deep expertise in antibody analytical development, including method development, characterization, and CQA definition.
Proven experience with developability assessments and scalability testing for large molecules.
Demonstrated success leading cross‑functional technical teams and managing complex development programs.
Preferred
Experience with AI‑enabled protein engineering, novel expression systems, or platform development.
Strong understanding of tech transfer, manufacturing readiness, and regulatory expectations for biologics.
Track record of implementing automation, high‑throughput screening, or data‑driven process optimization.
FAQs
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