Supervisor - Biomanufacturing, Downstream/mRNA

Catalent; Madison (WI); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, dental and vision benefits

Tuition Reimbursement

Competitive PTO

Career growth opportunities

Job summary

Catalent, Inc. in Madison, Wisconsin is seeking a Supervisor - Biomanufacturing, Downstream/mRNA to lead the Downstream/mRNA team in a 24/7 operation. You will oversee chromatography, filtration, viral reduction, and bulk drug substance filling in a cGMP environment, ensuring readiness and adherence to production schedules.

This role requires strong leadership, communication, and regulatory compliance knowledge (cGMP, ICH, FDA). Shift: Sunday–Wednesday, 10pm–8am, onsite at Madison site.

Qualifications

• High School Diploma plus 6 years GMP experience.
• Master’s degree with 2+ years OR Bachelor’s/Associate with 4+ years.
• Ability to clearly communicate technical information and ensure regulatory compliance (cGMP, ICH, FDA, EMA).
• Proven leadership to drive continuous improvement and manage multiple activities.

Responsibilities

• Oversee manufacturing operations to meet schedule, quality, and cost objectives.
• Lead staff development, address performance, and ensure regulatory compliance.
• Maintain cGMP documentation including SOPs and batch records.
• Support audits and lead technical discussions and investigations.
• Manage cleanroom operations, equipment readiness, and maintenance.
• Coordinate scheduling and resources with leadership and provide coverage as needed.

Skills

Leadership

Communication

Cross-functional coord

Process improvement

Education

Bachelor’s or Associate degree plus relevant experience

Master’s degree with 2+ years OR Bachelor’s/Associate with 4+ years

Job description

Supervisor - Biomanufacturing, Downstream/mRNA Role (0097530) – Madison, WI

About Site

Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 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 Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem.

Position Summary

We 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, viral reduction, 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: Sunday - Wednesday, 10pm-8am

Location: Madison, WI

100% Onsite

The Role

• Oversees all assigned manufacturing operations to ensure products are produced on schedule, within quality standards, and aligned with cost objectives.
• Leads, develops, and evaluates staff, addressing performance issues promptly and ensuring compliance with company policies and regulatory requirements.
• Communicates decisions, policies, and operational updates to personnel to support strong performance and engagement.
• Authors, revises, and maintains cGMP documentation, including Standard Operating Procedures, Batch Production Records, forms, and job aids.
• Supports internal, client, and regulatory audits by preparing documentation and ensuring operational readiness. Leads technical discussions, investigations, and project‑related calls, providing subject‑matter expertise for manufacturing activities.
• Maintains and strengthens the Quality System, including floor compliance, deviation investigations, and change control execution.
• Manages cleanroom operations, including 5S adherence, housekeeping, equipment cleaning, and review/sign‑off of executed cGMP records. Oversees equipment readiness, including routine and preventive maintenance, qualification/validation activities, and support for technology transfer.
• Coordinates scheduling and resource allocation with leadership, drives continuous improvement initiatives, and provides shift or off‑shift coverage as required.
• Other duties as assigned.

Minimum 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.

Catalent offers rewarding opportunities to further your career!

Join the global drug development and delivery leader and help us bring over 7,000 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.

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 [e-mail]. 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.