3rd Shift Supervisor, cGMP Biomanufacturing Downstream

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Senior Supervisor – Downstream Biomanufacturing (Third Shift) Location: Madison, Wisconsin Position Type: Full-Time Shift: Third Shift – Sunday through Wednesday, 10:00 PM–8:00 AM Pay Rate: $53.00 per hour Schedule: Four 10-hour shifts Position Overview We are seeking an experienced and decisive Senior Supervisor to lead third-shift Downstream Biomanufacturing operations in a fast-paced, regulated cGMP manufacturing environment. This position is ideal for a strong people leader who has demonstrated the ability to independently manage employees, make sound operational decisions, enforce performance expectations, and maintain manufacturing execution and compliance standards without relying on immediate management support. The Senior Supervisor will oversee a team of approximately 5–15 employees responsible for downstream biologics manufacturing activities supporting clinical and commercial drug substance production. The successful candidate will be comfortable working cross-functionally with Quality Assurance (QA), Manufacturing Science & Technology (MS&T), Engineering, and other support departments to resolve operational challenges, maintain production schedules, and ensure compliance with established procedures and regulatory requirements. Strong leadership and employee management experience are the highest priorities for this position. Technical downstream manufacturing experience and biologics industry experience are valuable, but the ability to independently lead, coach, develop, and hold employees accountable is essential.

Key Responsibilities

People Leadership & Employee Accountability

• Independently lead and supervise third-shift manufacturing personnel.
• Provide daily direction, coaching, and performance management to a team of approximately 5–15 employees.
• Establish and enforce expectations regarding attendance, punctuality, productivity, performance, and GMP compliance.
• Address employee performance concerns, attendance issues, and disciplinary matters promptly and professionally.
• Conduct performance evaluations and provide recommendations regarding employee development, promotions, and compensation.
• Participate in interviewing, hiring, onboarding, and employee development.
• Foster a culture of accountability, teamwork, safety, and operational excellence.
• Make independent decisions and resolve employee and operational issues during overnight operations.

Manufacturing Operations & GMP Compliance

• Oversee downstream biologics manufacturing activities in clinical and commercial cGMP environments.
• Ensure manufacturing activities are performed in accordance with approved SOPs, batch records, and regulatory requirements.
• Maintain a strong floor presence to support production execution and employee performance.
• Ensure batch manufacturing readiness and adherence to production schedules.
• Promote a right-first-time manufacturing culture and maintain data integrity.
• Monitor production activities and proactively address operational challenges.
• Ensure compliance with applicable cGMP, FDA, EMA, and ICH requirements.

Downstream Manufacturing Activities

Provide leadership and oversight for manufacturing operations involving:

• Column chromatography.
• Normal flow filtration.
• Tangential flow filtration (TFF).
• Viral reduction and viral filtration.
• Bulk drug substance filling.
• Cleanroom and aseptic manufacturing operations.

Cross-Functional Collaboration

• Partner with Quality Assurance, MS&T, Engineering, and other support functions to resolve manufacturing issues.
• Communicate operational challenges and make timely decisions to maintain production schedules.
• Coordinate activities with supervisors from other shifts to ensure continuity of operations.
• Support Person in Plant (PIP) activities and customer-related manufacturing requirements.
• Escalate significant quality, safety, and operational concerns appropriately.
• Promote consistent communication and standard work practices across all shifts.

Continuous Improvement & Operational Performance

• Identify opportunities to improve manufacturing efficiency, employee performance, and operational processes.
• Support continuous improvement initiatives and standardization efforts.
• Optimize staffing and resource allocation based on production requirements.
• Monitor shift performance and ensure production deliverables are achieved.
• Support site objectives related to quality, safety, compliance, and financial performance.

Required Education & Experience

Candidates must meet one of the following education and experience combinations:

• Doctorate degree in a scientific, engineering, or biomanufacturing discipline with a minimum of three (3) years of relevant experience.
• Master's degree in a scientific, engineering, or biomanufacturing discipline with a minimum of six (6) years of relevant experience.
• Bachelor's degree in a scientific, engineering, or biomanufacturing discipline with a minimum of seven (7) years of relevant experience.
• Associate degree in a scientific, engineering, or biomanufacturing discipline with a minimum of nine (9) years of relevant experience.
• High school diploma with a minimum of ten (10) years of relevant experience.

Additional requirements:

• More than two (2) years of demonstrated leadership or supervisory experience.
• Significant experience independently managing employees and making operational decisions.
• Demonstrated ability to address employee performance, attendance, accountability, and disciplinary matters.
• Experience working in a regulated manufacturing or GMP environment.
• Ability to independently lead an overnight manufacturing operation.

Preferred Qualifications

• Biopharmaceutical or biologics manufacturing experience.
• Experience in downstream processing and drug substance manufacturing.
• Knowledge of cGMP regulations and FDA/EMA requirements.
• Cleanroom, aseptic technique, and general laboratory equipment experience.
• Experience with chromatography, filtration, and bulk drug substance manufacturing.
• Experience collaborating with QA, MS&T, Engineering, and other manufacturing support departments.

Required Leadership & Technical Skills

• Strong people management and employee accountability skills.
• Excellent decision-making and problem-solving abilities.
• Ability to lead independently in a fast-paced overnight manufacturing environment.
• Strong communication and conflict-resolution skills.
• Ability to communicate complex technical information to different audiences.
• Ability to manage multiple priorities and maintain production schedules.
• Knowledge of GMP standards, SOPs, data integrity, and regulatory compliance.
• Ability to lead difficult conversations and resolve employee and operational challenges.
• Strong organizational skills and attention to detail.

Compensation & Schedule Pay Rate: $53.00 per hour

• Third Shift: Sunday–Wednesday.
• Hours: 10:00 PM–8:00 AM.
• Four 10-hour shifts per week.
• Approximately 40 hours per week.

Ideal Candidate The ideal candidate is an established manufacturing leader who can confidently take ownership of a third-shift operation. We are prioritizing candidates who have demonstrated success managing people, enforcing performance standards, addressing employee issues, and making independent decisions in a regulated manufacturing environment. A technically strong candidate who lacks meaningful people-management experience will not be the primary fit for this opportunity. Interested candidates are encouraged to apply!

Pay Details: $53.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.