Position SummaryWe have an opportunity for a Supervisor - Biomanufacturing, Downstream/mRNA to join our team. This role will lead the Downstream/mRNA team, overseeing one of six shifts in a 24/7 operation. The Supervisor will ensure successful execution of downstream production activities, including chromatography, filtration, and bulk drug substance filling in a cGMP environment. The position focuses on maintaining manufacturing readiness, meeting production schedules, and driving continuous improvement to support client and site objectives.
Shift: 6am-4pm, Wednesday-Saturday
Location: Madison, WI
100% Onsite
The Role- Oversee all 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 cGMP documentation, including Standard Operating Procedures, 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.
- Other duties as assigned.
The CandidateMinimum Requirements- High School Diploma minimum is required plus a minimum of 6 years of relevant experience in a GMP setting.
- Master’s degree with 2+ years OR a Bachelor’s/Associate’s degree with 4+ years of relevant experience in a scientific, engineering, or biomanufacturing discipline will also be accepted.
- Demonstrated ability to clearly communicate technical information to varied audiences, ensure data integrity and regulatory compliance (cGMP, ICH, FDA, 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.
- Physical requirements: 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 EHS responsibilities.
Preferred Skills & Background- Subject Matter Expert of downstream processing and mRNA products for commercial scale manufacturing.
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 + 8 paid holidays.
- Community engagement and green initiatives.
- Medical, dental and vision benefits effective day one of employment.
- Tuition Reimbursement.
