Bio-Manufacturing Supervisor 2nd Shift

Key Responsibilities:

• Lead and supervise hourly fermentation personnel on 2nd shift, including work assignment, on‑floor guidance, and performance feedback.
• Conduct start‑of‑shift and end‑of‑shift meetings to communicate safety topics, production priorities, shift handoffs, and performance results.
• Partner with the Fermentation Manager to plan and sequence daily and weekly production to achieve unit, tank, yield, quality, and uptime goals.
• Coordinate with Engineering, Maintenance, and other functions to schedule and support preventive and corrective maintenance on bioreactors, centrifuges, freeze dryers, utilities, and related equipment.
• Support troubleshooting of equipment and process deviations, escalating issues promptly and contributing to root cause analysis and corrective actions.
• Ensure all production, cleaning, and maintenance records (e.g., batch records, logs, checklists) are completed accurately, in real time, and in compliance with internal and regulatory requirements.
• Maintain staffing and attendance oversight for the shift to ensure adequate coverage and continuity of operations.
• Collaborate closely with the 1st Shift Supervisor and other shifts to ensure clear handoffs, alignment on open work, and consistent application of procedures.
• Contribute to the creation, review, and revision of SOPs and work instructions for fermentation operations.
• Promote a culture of safety, quality, and continuous improvement through daily behavior, coaching, and participation in initiatives.

• Support onboarding, training, and cross‑training of fermentation personnel on processes, equipment, safety, and documentation requirements.
• Assist in reviewing production and performance data (e.g., yields, deviations, downtime) and recommend improvements in processes, methods, or equipment.
• Help maintain and update electronic tools (e.g., Excel, SharePoint, Fermentation Formula Masters) used by the fermentation team and on the production floor.
• Participate in internal or external audits, inspections, and investigations as requested.

• Manufacturing plant environment with exposure to noise, non‑temperature‑controlled areas, dust, fumes, odors, and biological materials.
• Routine work around bacteria, enzymes, chemicals, and process utilities, with strict adherence to hygiene and safety protocols.

• High school diploma or equivalent required.
• Additional training or coursework in fermentation, microbiology, bio‑manufacturing, or a related discipline preferred.

• 1+ year of experience in fermentation, bio‑manufacturing, or a related regulated production environment preferred.
• Experience leading, coordinating, or mentoring others in a manufacturing setting strongly preferred.
• Experience working under GMP, HACCP, FSMA, or similar quality and food safety systems.

• Working knowledge of GMP standards, QA/QC principles, and basic root‑cause problem solving.
• Familiarity with inventory management, including FIFO practices.

• Proficiency with basic computer applications (e.g., email, Excel, SharePoint, production or quality systems).
• Ability to perform basic math and interpret process parameters, trends, and production documentation.

• Leadership & Communication:
  Clearly communicates expectations, provides constructive feedback, and manages conflict professionally.
• Continuous Improvement:
  Identifies opportunities to improve safety, quality, efficiency, and reliability and helps implement solutions.
• Collaboration:
  
  Works effectively across shifts and functions (e.g., Quality, Maintenance, Engineering, Supply Chain) in a global organization.
• Results Orientation:
  Demonstrates dependability, strong follow‑through, and effective prioritization to meet production targets and deadlines.
• Attention to Detail & Organization:
  Maintains accurate records, organizes work effectively, and operates with minimal supervision.

• Forklift certification (or ability to obtain within a defined timeframe).

• Ability to lift up to 50 pounds periodically.
• Frequent standing, walking, bending, and movement throughout the facility.
• Ability to work in proximity to chemicals, enzymes, and biological materials while wearing required PPE.

• Follow all company safety procedures, GMP, HACCP, FSMA, OSHA, and site‑specific safety rules at all times.
• Consistently and correctly use required Personal Protective Equipment (PPE).
• Immediately report unsafe conditions, near misses, and incidents and actively participate in safety and food safety improvements.
• Adherence to all food safety procedures as per FDA regulations, including the FDA Food Safety Modernization Act (FSMA) or any other applicable federal, state, or local food safety regulations.