Supervisor - Biomanufacturing, Downstream/mRNA

Catalent•Madison, WI

6d•Onsite

About The Position

Catalent’s Madison, Wisconsin site is a biologics development and manufacturing facility supporting customers from research through early- and mid-stage clinical production. The site specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, with production scales from 50 to 4,000 liters for clinical manufacturing. The Supervisor - Biomanufacturing, Downstream/mRNA leads the Downstream/mRNA team and oversees one of six shifts in a 24/7 operation. The role ensures successful downstream production, including chromatography, filtration, viral reduction, and bulk drug substance filling in a cGMP environment. It focuses on manufacturing readiness, production schedules, and continuous improvement in support of client and site objectives. This position is Sunday through Wednesday, 10 p.m. to 8 a.m., and is 100% onsite in Madison, Wisconsin.

Requirements

High school diploma and at least 6 years of relevant experience in a GMP setting; alternatively, a master's degree with 2 or more years, or a bachelor's or associate degree with 4 or more years of relevant experience in a scientific, engineering, or biomanufacturing discipline.
Ability to clearly communicate technical information to varied audiences.
Ability to ensure data integrity and regulatory compliance, including cGMP, ICH, FDA, and EMA requirements.
Ability to integrate cross-disciplinary data using broad biologics and drug-development expertise while managing multiple concurrent activities.
Proven ability to influence, negotiate, and inspire stakeholders; anticipate perspectives, shape expectations, mentor others in persuasive communication, and align 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.
Must be able to see, hear, read, and write clear English.
Frequent sitting, standing, walking, reading written documents, using a computer monitor, reaching with hands and arms, talking, writing, and listening; occasional stooping, kneeling, crouching, bending, carrying, and grasping.
Frequent lifting or moving of up to 10 pounds and occasional lifting or moving of 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 Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and 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 aligned with cost objectives.
Lead, develop, and evaluate staff; address performance issues promptly and ensure compliance with company policies and regulatory requirements.
Communicate decisions, policies, and operational updates to personnel to support 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 manufacturing subject-matter expertise.
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.
Comply with EHS responsibilities.