Manufacturing Technical Lead
2 days ago
We are seeking a highly skilled Manufacturing Technical Lead to join our team at Genezen. As a key member of our manufacturing operations, you will be responsible for overseeing and executing floor operations to ensure safety, aseptic operations, and compliance with cGMPs are maintained at all times.
Key Responsibilities- Oversee and execute Genezen's therapeutic manufacturing processes in compliance with GMP regulations, ensuring the highest standards of quality, safety, and efficiency.
- Lead process optimization efforts, driving continuous improvement initiatives to enhance productivity, reduce waste, and minimize downtime.
- Act as the point of contact for Tech Transfer and collaborate with cross-functional teams to ensure smooth process transfer and scale-up from development to commercial production.
- Collaborate with compliance and documentation teams to provide technical expertise and feedback during the revision of documents.
- Conduct thorough process evaluations, identify areas for improvement, and implement corrective actions as needed.
- Monitor and analyze key process metrics, such as yield, cycle time, and equipment utilization, to identify trends and drive process optimization strategies.
- Support Supervisors in generating BOMs and requesting materials for non-commercial products.
- Ensure efficient use of material and equipment.
- HS Diploma and 10+ years related industry experience.
- BS or MS degree in Life Sciences/Engineering field with 5+ years of GMP Manufacturing experience.
- Prior leadership experience.
- Experience in a comparable position, in an industrial organization.
- Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures.
- Hands-on experience in writing and reviewing documentation.
- Experience in GMP manufacturing operations - USP, DSP, Buffer and DP.
- Paid vacation days, amount based on tenure.
- Paid sick time.
- 9 observed holidays + 1 floating holiday + 1 volunteer day.
- 401(k) plan with company match up to 6% of salary, vested immediately.
- Share Appreciation Rights.
- Choice of several healthcare plans.
- FSA and HSA programs.
- Dental & vision care.
- Employer-paid basic term life/personal accident insurance.
- Voluntary disability, universal life/personal accident insurance.
- Accidental Death & Dismemberment (AD&D) Insurance.
Genezen is a leading biotechnology company dedicated to advancing gene therapy and gene editing technologies. We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
We operate two locations: one in Fishers, Indiana, and the second in Lexington, Massachusetts. Both locations offer a unique blend of historical charm and modern amenities, making them great places to live and work.
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