Supervisor - Biomanufacturing, Downstream/mRNA

Catalent Pharma Solutions • Madison, WI

1d • Onsite

About The Position

Catalent is seeking a Supervisor - Biomanufacturing, Downstream/mRNA to lead the Downstream/mRNA team at its Madison, Wisconsin biologics development and manufacturing site. The role oversees one of six shifts in a 24/7 operation and ensures successful execution of downstream production activities, including chromatography, filtration, viral reduction, and bulk drug substance filling in a cGMP environment. It focuses on manufacturing readiness, meeting production schedules, and continuous improvement in support of client and site objectives.

The position is based onsite in Madison and works Sunday through Wednesday, 10 p.m. to 8 a.m. Catalent’s Madison facility supports research through early- and mid-stage clinical production and specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development.

Requirements

• High school diploma and at least 6 years of relevant experience in a GMP setting; alternatively, a master’s degree and 2+ years, or a bachelor’s or associate degree and 4+ years of relevant experience in a scientific, engineering, or biomanufacturing discipline.
• Ability to communicate technical information clearly to varied audiences and ensure data integrity and compliance with cGMP, ICH, FDA, and EMA requirements.
• Ability to integrate cross-disciplinary data using broad biologics and drug-development expertise while managing multiple concurrent activities.
• Ability to influence, negotiate, and inspire stakeholders, anticipate perspectives, shape expectations, mentor others in persuasive communication, and align diverse interests to drive complex decisions.
• Leadership ability to apply technical expertise to 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.
• Must be able to see, hear, read, and write clear English.
• Must comply with EHS responsibilities.
• Physical requirements include frequent sitting, standing, walking, reading documents, using a computer monitor, reaching, talking, writing, and listening; occasional stooping, kneeling, crouching, bending, carrying, and grasping; frequent lifting or moving up to 10 pounds and occasional lifting or moving up to 50 pounds.

Nice To Haves

• Subject-matter expertise in downstream processing and mRNA products for commercial-scale manufacturing.
• Demonstrable leadership experience at Catalent, including participation in programs such as NGGL, GOLD, LEAD Now, GM Excellence, or GROW; this may be considered in place of external experience.

Responsibilities

• Oversee assigned manufacturing operations to ensure products are produced on schedule, within quality standards, and in line with cost objectives.
• Lead, develop, and evaluate staff; promptly address performance issues and ensure compliance with company policies and regulatory requirements.
• Communicate decisions, policies, and operational updates to personnel.
• 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 and sign-off of executed cGMP records.
• Oversee equipment readiness, including routine and preventive maintenance, qualification and validation activities, and technology transfer support.
• Coordinate scheduling and resource allocation with leadership.
• Drive continuous improvement initiatives and provide shift or off-shift coverage as required.
• Perform other duties as assigned.

Benefits

• Competitive paid time off
• 8 paid holidays
• Medical benefits effective on the first day of employment
• Dental benefits effective on the first day of employment
• Vision benefits effective on the first day of employment
• Tuition reimbursement
• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team
• Community engagement and green initiatives

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED