Supervisor - Biomanufacturing, Downstream/mRNA

Catalent Pharma Solutions; Madison (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Catalent is seeking a Supervisor - Biomanufacturing, Downstream/mRNA in Madison, WI. You will lead the downstream team, ensuring manufacturing readiness, scheduling, and continuous improvement in a 24/7 operation, with a 6am–4pm Wednesday–Saturday shift.

Location is onsite and requires strong regulatory compliance experience. Responsibilities include overseeing operations, staff development, and cGMP documentation, with engagement in audits and cross-functional collaboration to meet client and

Qualifications

• Clear communication of technical information to varied audiences, ensure data integrity and regulatory compliance (cGMP, ICH, FDA, EMA).
• Influence, negotiate, and inspire stakeholders to drive complex decisions across teams.
• Leadership to design and guide strategic projects and continuous improvement.

Responsibilities

• 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 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 SME 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.

Skills

Leadership

Staff development

Communication

Regulatory knowledge

Project management

Education

Bachelor's degree in science

Master's degree in science

Job description

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, 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 Candidate 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. 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 [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.

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.

Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [e-mail] for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis. Massachusetts Lie Detector Test Notice: 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 may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time‑tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.