Position SummaryWe have an opportunity for a Supervisor - Biomanufacturing, Upstream to join our team. In this role, you will oversee manufacturing operations to ensure products meet quality, schedule, and cost objectives. You will lead and develop staff, maintain compliance with regulatory standards, and support audits and technical discussions. This position also involves managing cleanroom operations, equipment readiness, and driving continuous improvement initiatives.
Shift: 2nd shift 2pm-12am, Wednesday-Saturday (4x10)
Location: Madison, WI
100% Onsite
The Role- Oversee assigned manufacturing operations to ensure products are produced on schedule, within quality standards, and aligned with cost objectives
- Lead, develop, and evaluate staff, addressing performance issues promptly and ensuring compliance with company policies and regulatory requirements
- Communicate decisions, policies, and operational updates to personnel to support strong performance and engagement
- Author, revise, and maintain current Good Manufacturing Practice (cGMP) documentation, including Standard Operating Procedures (SOPs), Batch Production Records, forms, and job aids
- Support internal, client, and regulatory audits by preparing documentation and ensuring operational readiness; lead technical discussions, investigations, and project-related calls, providing subject-matter expertise for manufacturing activities
- Maintain and strengthen the Quality System, including floor compliance, deviation investigations, and change control execution
- Manage cleanroom operations, including 5S adherence, housekeeping, equipment cleaning, and review/sign-off of executed cGMP records; oversee equipment readiness, including routine and preventive maintenance, qualification/validation activities, and support for technology transfer
- Coordinate scheduling and resource allocation with leadership, drive continuous improvement initiatives, and provide shift or off-shift coverage as required
The CandidateMinimum Requirements- High School Diploma minimum is required plus a minimum of 6 years of relevant experience in a Good Manufacturing Practice (GMP) setting
- Master's degree with 2+ years or a Bachelor's degree with 4+ years of relevant experience accepted; degree should be in a scientific, engineering, or biomanufacturing discipline
- Demonstrated ability to clearly communicate technical information to varied audiences, ensure data integrity and regulatory compliance (cGMP, International Council for Harmonisation (ICH), Food and Drug Administration (FDA), European Medicines Agency (EMA)), and integrate cross-disciplinary data using broad biologics and drug-development expertise while managing multiple concurrent activities
- Proven capability to influence, negotiate, and inspire stakeholders by anticipating perspectives, shaping expectations, mentoring others in persuasive communication, and effectively aligning diverse interests to drive complex decisions
- Strong leadership in applying technical expertise to design and guide strategic projects, drive continuous improvement across teams and departments, set aligned objectives, allocate cross-functional resources, and develop team capabilities through clear planning and communication
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
- Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with Environmental Health and Safety (EHS) responsibilities.
Why You Should Join Catalent- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental, and vision benefits effective day one of employment
- Tuition Reimbursement
