Supervisor Biomanufacturing, Upstream

Catalents Madison Wisconsin site is a stateoftheart biologics development and manufacturing facility supporting customers from research through early and midstage clinical production. Located at 726 Heartland Trail in Madison the approximately 102700squarefoot GMP facility specializes in mammalian cell line engineering drug substance biomanufacturing and biopharmaceutical development utilizing flexible singleuse systems to enable rapid scaleup and customization. The site is home to Catalents proprietary GPEx and GPEx Lightning technologies which are used to generate highyielding mammalian cell lines for biologic therapies and supports production scales ranging from 50 to 4000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025 the Madison site has significantly increased capacity added new equipment and created approximately 200 highly skilled biohealth jobs further strengthening its role within Catalents global biologics network and Wisconsins growing life sciences ecosystem.

We have an opportunity for a Supervisor - Biomanufacturing Upstream to join our 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

• 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

• High School Diploma minimum is required plus a minimum of 6 years of relevant experience in a Good Manufacturing Practice (GMP) setting
• Masters degree with 2 years or a Bachelors 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.

• 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

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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