Principal Engineer/Principal Scientist - Antibody Drug Substance Development

Responsibilities
 

• Engage in all aspects of process design, tech transfer, and implementation of antibody drug substance manufacturing at Arcus’ CMO(s).
• Provide technical and scientific support to CMO(s) during clinical and/or commercial drug substance manufacturing including batch record review, technical data analysis, and process trouble shooting.
• Ensure each manufacturing process remains in a compliant state via technical review of change control, deviations and CAPA records.
• Author and review technical reports, data summaries and CMC related documents as required for regulatory submissions and responses.
• Prepare for and support quality audits and regulatory inspections.
• Partner with other functional areas (e.g., Development, Manufacturing, Clinical, Regulatory, etc.) to ensure our antibody development and manufacturing activities are always aligned with the highest quality standards (including cGMP compliance) and overall corporate objectives.

Qualifications
 

• BS or MS or PhD in Biochemistry, Biological Science, Chemical/Biochemical Engineering, or related discipline plus requisite pharmaceutical industry experience (B.S. with 9+ years of experience, or M.S. with 7+ years of experience, or PhD with 5+ years of experience).
• Proven track record in leading antibody process engineering activities during late-stage commercialization (e.g., process characterization, tech transfer and/or process validation).
• Subject matter expertise in antibody drug substance manufacturing including cell culture, filtration, and/or chromatography unit operations.
• Strong understanding of GMP requirements and regulations for clinical and/or commercial CMC drug development.
• Experience establishing process validation criteria, GMP specifications, in-process controls, process monitoring, and applying phase appropriate comparability approaches.
• Knowledge of regulatory guidelines relevant to GMP work. Experience in regulatory submissions and/or inspections with regulatory authorities.
• Strong aptitude to think strategically, with excellent analytical, communication, presentation and writing skills, including extensive experience authoring technical reports.
• Ability to work collaboratively with internal and external partners in a matrix structure to ensure timelines and deliverables are met.