Biotechnology Process Engineer
7 days ago
Genezen is a cutting-edge biotechnology company committed to delivering innovative gene therapies. With a strong focus on scientific excellence, we strive to accelerate treatments for patients.
Our Commitment
We operate with urgency and a commitment to delivering timely treatments by accelerating our partners' programs. Our team is dedicated to overcoming challenges, learning from failures, and persistently striving for success.
Job Summary
The Manufacturing Sciences & Technology (MSAT) group plays a critical role in successful manufacturing of clinical and commercial products. As a Biotechnology Process Engineer, you will assist the MSAT team in the transfer of technologies, process validation, and cGMP manufacturing of Genezen's gene therapy products.
Responsibilities:
- Assist technology transfer to GMP manufacturing facilities by reviewing master batch records and providing on-floor support for transfer operations.
- Verify technical data in support of reports, impact assessments, memos, etc.
- Assist manufacturing technical support, including process trouble-shooting, root cause analysis, and investigation on process and/or quality discrepancies and deviations during GMP productions, change controls, and CAPAs.
- Cross-functionally collaborate with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation, and Supply Chain as needed.
- Support planning and execution of process/product life cycle management, including continuous process improvements to improve process robustness/capacity/productivity and increase level of safety and/or compliance.
Requirements:
- Bachelor's Degree in Engineering or other related scientific discipline.
- Master's Degree in Engineering or other related scientific discipline (desired).
- BS (0-3) or MS (0-1) with relevant experience or degree in gene therapy or other biotechnology field.
- Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal.
- Ability to present to and interact with others to achieve cross-functional goals.
- Ability to handle pressure and address multiple topics in parallel to meet timelines.
- Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner.
Salary Range: $120,000 - $150,000 per year
About the Location: Genezen operates two locations: Fishers, Indiana, and Lexington, Massachusetts. Both cities offer a high quality of life, with access to professional and college sports teams, cultural events, and outdoor activities.
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