cGMP Production Operations Supervisor

SPL Biopharma; Waunakee (WI); On-site; USD 75,000 - 110,000; Full time

Job summary

SPL Biopharma is seeking an experienced cGMP Production Operations Supervisor for the 3rd shift (4:00 PM–4:00 AM), Wednesday and Thursday with every other weekend. You will lead a high-performing team on nightly manufacturing, coaching operators, and ensuring real-time compliance with SOPs and cGMP requirements.

As the shift’s primary contact, you’ll coordinate changeovers, log issues, and escalate deviations while partnering with Quality, Maintenance, and other functions to sustain on-time

Qualifications

• Associate degree required; higher degree preferred.
• Minimum 3 years in cGMP manufacturing.
• 1+ year of leadership experience preferred.
• Proficient in GMP, SOPs, and PPE usage.

Responsibilities

• Lead and supervise the nightly cGMP manufacturing operations to ensure safe, compliant production.
• Review batch records, ensure documentation accuracy, and support audits and deviations as needed.
• Champion safety on the floor; enforce PPE use and gowning procedures and raise incidents promptly.
• Direct shift coverage, train operators, manage performance, and schedule to meet production goals and budgets.

Skills

Leadership

GMP

Production scheduling

SOPs

PPE usage

ALCOA+

Education

Associate degree

Bachelor’s degree preferred

Job description

cGMP Production Operations SupervisorStep into a hands-on leadership role where you guide a high-performing team through nightly cGMP manufacturing operations. You’ll orchestrate safe, compliant, and efficient production, protect documentation integrity in real time, and act as the go-to escalation point for your crew.Your Schedule3rd shift: 4:00 PM – 4:00 AM, every Wednesday, Thursday, and every other weekend.A Day (and Night) in This RoleYou begin by reviewing the plan, confirming equipment readiness, and leading a concise handoff meeting. Throughout the shift, you stay on the floor—coaching operators on process equipment, verifying that instructions are executed precisely and on time, and resolving issues as they surface. You keep production on schedule, uphold SOP and cGMP requirements, and keep safety at the forefront. As the shift’s primary contact, you communicate status, issues, and next steps during changeover so the next team hits the ground running.What You’ll OwnOperations LeadershipGuide the execution of manufacturing instructions and ensure product meets specifications in line with SOPs, cGMP, company policies, and safety standards.Operate and mentor others on production equipment and processes to drive accuracy and efficiency.Continuously monitor operations, troubleshoot routine issues in real time, and serve as the shift’s escalation point.Lead shift huddles and changeover meetings; clearly communicate performance, risks, and priorities.Balance resources—personnel, materials, and equipment—to meet production goals, performance targets, and budget expectations.Ensure required tools, supplies, equipment, and staffing are in place for uninterrupted production.Compile reports on schedules, goals, equipment status, and maintenance concerns; contribute to studies and analyses as needed.Partner with department leadership to build and adjust finite schedules to meet deadlines.Quality & Documentation (cGMP)Review batch records, logbooks, and related documentation as work progresses to ensure accuracy and completeness.Reinforce best documentation practices (ALCOA+) and cultivate a right-first-time mindset across the team.Escalate deviations, nonconformances, and safety concerns promptly; support immediate containment and corrective actions.Participate in investigations of deviations, incidents, or out-of-specification results and contribute to timely resolutions.Maintain continuous compliance with policies, SOPs, cGMP, safety, and housekeeping expectations.Support internal/external audits, regulatory inspections, and audit-readiness activities.Safety & Environmental StewardshipChampion a proactive safety culture on the floor.Ensure proper use of PPE and strict adherence to gowning requirements.Raise and document safety incidents and near-misses in a timely manner.Team LeadershipDirectly supervise operators; verify training and qualification before task assignment.Build and maintain shift coverage, including scheduling, attendance oversight, and creation of the team’s finite schedule.Coach operators on correct techniques and procedures; provide clear expectations and feedback.Develop, mentor, recognize, and when needed discipline team members; conduct performance reviews; foster morale and motivation.Problem Solving & Continuous ImprovementAssist with equipment and process troubleshooting; identify root causes and communicate outcomes to senior leadership.Spot improvement opportunities and either lead or support implementation actions.Advise management on day-to-day operational needs and recommend enhancements to processes and systems.Cross-Functional Collaboration & ReportingWork closely with Quality, Maintenance, Warehouse, and other partner groups to keep work moving.Contribute to multi-functional teams and collaborate with external vendors and senior leaders as required.Track process performance and prepare business reports using databases, documents, and spreadsheets.QualificationsAssociate degree required; Bachelor’s degree or higher preferred. Relevant experience may substitute for formal education.Minimum 3 years in cGMP manufacturing required; 1+ year of leadership experience preferred.Proficiency in Good Manufacturing Practices (GMP), production scheduling, SOPs, and proper PPE usage.