Biologics Process Development Senior Director - Process Development

Job Summary

The Senior Director of Biologics Process Development will provide strategic and operational leadership for the Process Development group, with a specialized focus on complex biologics utilizing CHO cell culture platforms. This leadership role requires a deep technical background in running bioreactors within a process development setting alongside the ability to lead a high-performing group of Process Scientists and Engineers.

The successful candidate will oversee the development, optimization, and technology transfer of robust manufacturing processes across multiple biologics programs from early to late-stage development. This role coordinates closely with internal research, analytical, and manufacturing teams to ensure the seamless transition of programs from Research to Development, the successful execution of internal PD studies, and the timely production of material for toxicology and clinical studies.

Primary Responsibilities

• Serves as Process Development department head overseeing planning, execution, resource allocation, and project delivery in a fast-paced environment 
• Manage, mentor and facilitate the development of the staff in Upstream and Downstream Process Development 
• Provide deep subject matter expertise in CHO cell culture development, including media optimization, feeding strategies, and cell line evaluation for complex biologics (e.g., bispecifics, fusion proteins, heavily glycosylated proteins)
• Oversee upstream bioreactor operations (from bench-top to pilot scale), leveraging strong hands-on experience in bioreactor design, scale-up dynamics, and process characterization within a PD setting
• Drive innovation and development of process technologies that can result in significant increases in efficiency and purity 
• Maintain a strong working knowledge of downstream purification technologies to ensure cohesive, end-to-end integrated process development
• Oversee the execution of process development studies, data review, and comprehensive documentation according to established laboratory procedures and data integrity standards
• Facilitate early program transitions from Research to Development, ensuring processes are scalable and fit for development realities
• Operate within a cross-functional project team environment and coordinate efforts with all relevant internal functional areas including Quality, Manufacturing, Analytical Development, Program Management, Research, non-Clinical (Tox) 
• Have direct experience with establishing production processes for biologics in cGMP manufacturing settings 
• Assure cGMP success through effective tech transfer and support of cGMP manufacturing. Coordinate efforts with manufacturing to achieve program success 
• Lead tech transfer to CDMOs and mentor team members to support tech transfers 
• Determine areas for gaining efficiency, coordinates with individual groups and ensure harmonized implementation of best practices 
• Experience throughout the biopharmaceutical product life-cycle including process characterization studies, in-process control strategy and process validation is preferred but not required

Preferred Skills

• Management experience must include managing a team of at least 5
• Experience reviewing and/or authoring CMC sections for regulatory submissions
• Demonstrated ability to work cross functionally to achieve goals
• Knowledge of upstream and downstream process development for biologics
• Ability to multi-task and handle successful execution of multiple parallel programs
• Knowledge of cGMP and manufacturing operations
• Knowledge of tech transfer
• Knowledge of good lab practices including hands-on implementation
• Knowledge of regulatory guidelines, particularly those for IND filing

Education Requirements

• Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or a related scientific discipline with 10+ years of industry experience; or an M.S./B.S. with 14+ years of relevant biopharmaceutical experience
• Minimum of 5+ years of experience successfully managing and developing technical teams of scientists and engineers in a biopharmaceutical setting

Potential base pay range 240000 - 277000 USD