Director, Process Development
$200,000–$230,000 year
HybridLexington, Massachusetts, United States
Job Summary
Oversee the Process Development group, managing Upstream and Downstream scientists to lead biologics programs from research to development. Direct bench-scale to pilot-scale bioreactor operations, optimizing critical culture conditions for growth and product quality while driving tech transfer to cGMP manufacturing. Coordinate with cross-functional teams including Quality, Manufacturing, and Program Management to ensure seamless material supply for toxicology studies and other internal groups. Establish production processes, maintain budgets, and implement best practices to improve efficiency and purity. Mentor staff and facilitate career development within a fast-paced environment focused on altering TGF-β signaling pathways for blood cell and tissue disorders.
Required Qualifications
- Bachelor of Science degree in a scientific discipline
- Minimum of 10 years of technical management experience
- Master's degree in a scientific or biochemical engineering area
- Doctorate degree in a scientific or biochemical engineering area
- At least 5 years' experience serving in a relevant managerial capacity
- Management experience must include managing a team of at least 5
Desired Qualifications
- 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
- Experience throughout the biopharmaceutical product life-cycle including process characterization studies, in-process control strategy and process validation
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