Position Responsibilities
- Supervise facilities, equipment, and personnel in the Cell Fermentation department; coordinate additional labor.
- Lead and participate in safety programs (Safe by Choice).
- Supervise aseptic procedures (media preparation, antigen inoculation/harvest, tissue culture preparation/harvest).
- Antigen storage and sampling for testing; review/revise processes for corporate/regulatory compliance.
- Review production records for completeness/compliance with SOPs; train personnel on regulations and corporate policies.
- Evaluate staffing/equipment needs and recommend improvements; guide personnel to maximize throughput.
- Coordinate with vendors on equipment options; support procurement/installation of new equipment.
- Schedule and plan department requirements; coordinate resources across areas via Tier process.
- Coordinate problem-solving with third parties; communicate/track critical component issues with vendors.
- Ensure safety/SOP/aseptic technique compliance; review practices to ensure employees meet procedures.
- Coordinate SAP/data entry and movement of finished goods/in-process products; manage inventory movements and production KPIs.
- Participate in KATA/KAIZEN continuous improvement; lead Tier 1 meetings; other duties as assigned.
Education Requirement
- HS/GED + 6 yrs leadership in manufacturing/military (or 5 yrs in direct GMP biotech) OR Associateโs + 4 yrs leadership (or 3 yrs direct GMP) OR Bachelorโs + 4 yrs manufacturing/military (or 2 yrs direct GMP).
Required Experience & Skills
- 5+ yrs manufacturing experience; 1+ yrs leadership.
- Proficient in Microsoft Office; strategic communication; analytical problem-solving; mentoring/coaching.
Preferred Experience & Skills
- Vaccine/pharma industry; USDA/GMP; aseptic techniques/filling; cell culture/bioreactors/process equipment; SAP.
Required Skills
- Adaptability, aseptic manufacturing, cGMP compliance, data analysis, inventory management, operational excellence, people leadership, production scheduling, sterile filling, etc.
Benefits
- Annual bonus/long-term incentive (if applicable); comprehensive medical/dental/vision, retirement (401k), paid holidays/vacation, compassionate and sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Deadline shown on posting.