Manufacturing Operations Manager

2 weeks ago


Lexington, Kentucky, United States Genezen Full time
Job Summary

We are seeking a highly skilled Manufacturing Supervisor 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
  • Supervise, train, and mentor the upstream, downstream, drug product, and banking (Cell/Virus) teams.
  • Create a high-performance team that emphasizes strengths-based execution, accountability, open communication, people development, and continuous improvement.
  • Primary contact for troubleshooting and issue resolution or escalation.
  • Create and follow up on work orders.
  • Communicate/coordinate day's scheduling and staffing plan.
  • Oversight and execution of all routine and critical operations (upstream, downstream, and cell/virus banking as well as commissioning and validation activities).
  • Ensure documentation is complete, reviewed, and meets good documentation practices (forms, logbooks, solution records, batch records, etc.).
  • Responsible for floor inventory and communicating schedule changes as needed.
  • Identify and support process changes/improvements or safety/ergonomic improvements.
  • Ensure work is carried out in a safe manner, take action on safety issues and risks.
  • Ensure that the department is in a continuous state of readiness for production and GMP audits.
  • When needed, independently perform manufacturing of uniQure's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements.
Requirements
  • Adaptability required as work schedule may change based on business needs.
  • Criminal background check required.
  • Other duties as assigned.
What We Offer
  • 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.
About Genezen

Genezen is a fast-growing company dedicated to delivering timely treatments to patients by accelerating our partners' programs. We operate two locations: one in Fishers, Indiana, and the second in Lexington, Massachusetts. Our team is committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.



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