Biomanufacturing Operations Team Lead

Job Description

Job Description

Biomanufacturing Operations Team Lead

Do you thrive on keeping a GMP floor running smoothly? Are you a coach who turns complex instructions into flawless execution? Can you spot a documentation gap before it becomes a deviation—and act as the escalation point when the unexpected happens? If so, this role is designed for you.

Work Hours

3rd shift : 4:00 PM – 4:00 AM on Wednesdays, Thursdays, and every other weekend.

What You’ll Lead

• Production excellence: Keep operations on plan by guiding operators through manufacturing instructions, verifying equipment readiness, and ensuring products meet specifications under SOP and cGMP controls.
• Real-time decisioning: Monitor processes, resolve routine issues immediately, and serve as the primary point of contact for your shift.
• Resource orchestration: Balance personnel, material, and equipment to meet schedule, performance objectives, and budget targets.
• Shift communication: Lead concise changeover meetings, report status and issues, and ensure the incoming team has what they need to succeed.
• Scheduling partnership: Build the finite schedule for your team and partner with managers and department leadership to align on deadlines.

Quality & Compliance—No Compromises

• Audit batch records, logbooks, and supporting documents in the moment for accuracy and completeness.
• Champion ALCOA+ practices and a right-first-time culture to minimize rework.
• Escalate deviations, nonconformances, and safety issues promptly; help drive immediate containment.
• Participate in root-cause investigations for deviations, incidents, or out-of-specification results and assist with corrective actions.
• Uphold policies, SOPs, cGMP, safety protocols, and housekeeping standards at all times.
• Support internal and external audits, regulatory inspections, and ongoing audit-readiness efforts.

Safety First, Always

• Model and reinforce safe behaviors on the floor.
• Ensure proper PPE use and strict compliance with gowning procedures.
• Report and escalate safety concerns and incidents without delay.

Grow People, Grow Performance

• Directly supervise hourly operators, ensuring each is trained and qualified before task assignment.
• Own shift coverage, attendance tracking, and scheduling for your team.
• Coach proper techniques, set clear expectations, recognize achievements, and address performance issues when necessary.
• Conduct performance reviews and build team morale through transparent goals, policy communication, and consistent feedback.

Fix Problems, Improve Systems

• Troubleshoot equipment and process issues; identify root causes and communicate findings to senior management.
• Spot improvement opportunities, then support or lead implementation to elevate safety, quality, and throughput.
• Provide operational insight and recommendations to leadership on process enhancements.

Partners in Progress

• Collaborate closely with Quality, Maintenance, Warehouse, and other teams to remove roadblocks.
• Engage in cross-functional initiatives and coordinate with external vendors and senior leaders when required.
• Track process performance and meet business reporting needs using databases, documents, and spreadsheets.

What You Bring

• Associate degree required; Bachelor’s preferred. Relevant experience may substitute for formal education.
• At least 3 years in cGMP manufacturing; 1+ year of people leadership preferred.
• Comfort with GMP principles, production scheduling, SOPs, and correct PPE usage.