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Lead Bioprocess Scientist in Advanced Therapies
2 months ago
Position Overview:
The Lead Bioprocess Scientist (Downstream) is a pivotal role in the realm of Advanced Therapies Manufacturing. This position is essential for the development, execution, and technical transfer of compliant manufacturing processes for gene therapy drug substances and products aimed at both clinical and commercial applications.
Key Responsibilities:
- Develop profound technical knowledge regarding the science underlying the molecule and associated processes.
- Provide comprehensive technical support for all start-up activities, including technology transfer, process validation, and ongoing process stewardship.
- Possess extensive hands-on experience with chromatography operations, tangential flow filtration (TFF), viral filtration, and sterile filtration.
- Take ownership of bioprocess technical stewardship and lead root cause analysis for deviations, along with impact assessments for changes.
- Collaborate effectively within cross-functional teams, fostering partnerships with operations and development to integrate scientific and engineering principles with on-floor operations.
- Assess process control strategies to ensure processes are consistently validated and capable of meeting their intended purposes.
- Identify and implement process improvements, actively participating in Lean manufacturing initiatives.
- Prepare, review, and provide technical support for essential documentation, including change controls, regulatory submissions, and validation protocols.
- Lead technical projects aimed at enhancing process control, yield, product quality, and productivity.
- Monitor and respond to established metrics in real-time to evaluate process variability and capability.
- Support audit processes as necessary, ensuring compliance with safety regulations and promoting a culture of safety.
Qualifications:
A Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or a related Science/Engineering field is required, along with a minimum of 3 years of experience in pharmaceutical manufacturing, particularly in Operations, Validation, or Engineering.
Preferred Skills:
- In-depth understanding of gene therapy manufacturing processes.
- Experience with large-scale AAV vector production utilizing single-use bioreactor systems.
- Familiarity with solution filling equipment and isolator technology.
- Strong analytical skills for data trending and problem-solving.
- Excellent communication skills, both oral and written, to effectively convey information across all organizational levels.
This role is an opportunity to contribute significantly to the advancement of innovative therapies and enhance patient outcomes through the application of cutting-edge bioprocessing technologies.
