Biomanufacturing Operations Team Lead

SPL Biopharma; Waunakee (WI); On-site; USD 85,000 - 105,000; Full time

Job summary

SPL Biopharma is seeking a Biomanufacturing Operations Team Lead for the 3rd shift (4:00 PM–4:00 AM, Wed, Thu, and every other weekend). You will guide operators, verify equipment readiness, and ensure products meet specifications under SOP and cGMP controls.

Responsibilities include audit readiness, incident escalation, and driving immediate containment of deviations, while fostering a right-first-time culture and coaching the team to grow performance.

Qualifications

• Associate degree or equivalent; Bachelor’s preferred.
• At least 3 years in cGMP manufacturing; 1+ year of people leadership preferred.
• Comfort with GMP principles, production scheduling, SOPs, and correct PPE usage.

Responsibilities

• Lead and coach hourly operators to ensure flawless execution of manufacturing instructions on the GMP floor.
• Audit batch records, logbooks, and supporting documents for accuracy and completeness; champion ALCOA+ practices.
• Escalate deviations, nonconformances and safety issues promptly; participate in root-cause investigations and corrective actions.

Skills

People leadership

cGMP knowledge

SOP compliance

Root-cause analysis

Process troubleshooting

Shift communication

Training and qualification

Education

Associate degree

Bachelor’s degree preferred

Job description

Biomanufacturing Operations Team LeadDo 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 Hours3rd shift: 4:00 PM – 4:00 AM on Wednesdays, Thursdays, and every other weekend.What You’ll LeadProduction 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 CompromisesAudit 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, AlwaysModel 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 PerformanceDirectly 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 SystemsTroubleshoot 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 ProgressCollaborate 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 BringAssociate 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.