Biotechnology Process Engineer

7 days ago


Lexington, Massachusetts, United States Genezen Full time
About Genezen
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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