Manager - Biomanufacturing, Downstream​/mRNA

Manager - Biomanufacturing, Downstream/mRNA Position Summary

• Work Schedule:
  
  Monday – Friday, core hours 8am-5pm
• 100% on-site (Madison, WI)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single‑use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

The Manager for Biomanufacturing will oversee the Downstream/mRNA team, comprising six shifts and 24/7 operations. You will be responsible for the successful execution of downstream production activities, including column chromatography, normal flow filtration / tangential flow filtration (TFF), viral reduction/filtration, and bulk drug substance filling in a clinical and commercial cGMP environment. You will ensure batch manufacturing readiness, meet production schedule deliverables, drive a continuous improvement culture, and continually optimize staff and operating model to support client program requirements and site financial objectives.

• 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 SOPs, 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

• High School Diploma minimum is required plus a minimum of 8 years of relevant experience, defined as:
  Minimum of 2 years of leadership experience plus hands‑on experience with clean rooms, aseptic techniques, and general laboratory equipment in a GMP setting
• We will also accept a Master’s degree with 4+ years OR a Bachelor’s degree with 6+ years of relevant experience. The degree should be in a scientific, engineering, or biomanufacturing discipline
• Technical Requirement:
  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
• Behavioral Requirement:
  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
• Leadership Requirement:
  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…