Senior Biotechnologist to lead the design, optimization, and scale-up of biologics and advanced therapy processes in a regulated biopharmaceutical environment.
Key Responsibilities
- Develop robust upstream and/or downstream bioprocesses.
- Drive technology transfer into GMP manufacturing.
- Support process characterization, validation, and preparation of regulatory filings.
- Troubleshoot complex technical issues in collaboration with global, cross-functional teams.
- Apply data-driven, Quality by Design (QbD) approaches to improve process performance.
- Mentor scientists and contribute to a culture focused on safety, quality, and patient outcomes.
Qualifications & Skills
- Strong expertise in bioprocess development and scale-up for biologics/advanced therapies.
- Experience with GMP tech transfer, validation, and regulatory documentation.
- Ability to lead root-cause investigations and resolve technical challenges.
- Knowledge of QbD principles and data-driven process optimization.
- Effective communication and leadership in cross-functional teams.