Director, Process Development

Job Summary

This role is responsible for providing overall management of the Process Development group with a focus on biologics. The position will lead a group of Process Scientists and Engineers in the development and tech transfer of processes for different stages of multiple biologics programs.  The candidate will also coordinate with multiple internal teams to support successful, early program transition from Research to Development, internal process development studies, and production of material for toxicology studies.

Primary Responsibilities

• Serves as Process Development department head overseeing planning, execution, and project delivery in a fast-paced environment 
• Manage, mentor and facilitate the development of the staff in Upstream and Downstream Process Development 
• Strong working knowledge of upstream and downstream process technologies
• Provide hands-on expertise and strategic guidance for bench-scale to pilot-scale bioreactor operations, ensuring scalable and robust processes
• Design and execute studies to evaluate critical culture conditions (e.g., pH, DO, feeding profiles, shear stress) to optimize growth, viability, and product quality
• Drive innovation and development of process technologies that can result in significant increases in efficiency and purity
• Partner closely with downstream teams to ensure seamless interface between cell culture harvest and purification steps
• Operate within a cross-functional project team environment and coordinate efforts with all relevant internal functional areas including Quality, Manufacturing, Analytical Development, Program Management, Formulation Development, Research, non-Clinical (Tox) 
• Lead group in successful operations for supply of material for use by other groups (Bioanalytical, Tox, etc) and process development studies 
• Have direct experience with establishing production processes for biologics in cGMP manufacturing settings 
• Determine areas for gaining efficiency, coordinates with individual groups and ensure harmonized implementation of best practices 
• Support the development and maintenance of budgets, manpower and capital requirements for process development group  
• Actively provides career path and development for team members 
• Execution of process development studies, review of the data, and documentation of all activities according to the appropriate laboratory procedure 
• 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
• Proven track record of running, programming, and scaling bench-to-pilot scale bioreactor systems
• 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

• Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 10 years of technical management experience; a Master's degree with 8 years or a Doctorate degree in a scientific or biochemical engineering area (or equivalent. Additionally, at least 5 years’ experience serving in a relevant managerial capacity required