Catalent, Inc.
Biomanufacturing
SupervisorBiomanufacturing,Downstream/mRNA
“Supervisor - Biomanufacturing, Downstream/mRNA at Catalent, Inc.. Skills: Biomanufacturing, Downstream Processing, cGMP Operations, Team Leadership. Oversee manufacturing operations. Ensure products produced on schedule”
What You'll Achieve.
Meet production schedule deliverables; Support client program requirements; Support site financial objectives
Industry & Context.
Address performance issues promptly; Deviation investigations
100% on-site (Madison, WI), 2nd shift 2pm-12am, Wednesday-Saturday, 6 shifts and 24/7 operations, 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.
What They're Looking For.
Must Have
High School Diploma minimum is required plus a minimum of 6 years of relevant experience in a GMP setting, Demonstrated ability to clearly communicate technical information to varied audiences, ensure data integrity and regulatory compliance (cGMP, ICH, FDA, EMA), integrate cross‑disciplinary data using broad biologics and drug‑development expertise, managing multiple concurrent activities, Proven capability to influence, negotiate, and inspire stakeholders, anticipating perspectives, shaping expectations, mentoring others in persuasive communication, effectively aligning diverse interests to drive complex decisions, 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, develop team capabilities through clear planning and communication, 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, occasional lifting and/or moving up to 50 pounds, comply with EHS responsibilities
Nice to Have
Master’s degree with 2+ years OR a Bachelor’s degree with 4+ years of relevant experience in a scientific, engineering, or biomanufacturing discipline, 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
What You'll Do.
Oversee manufacturing operations
Ensure products produced on schedule
Ensure products within quality standards
Ensure products aligned with cost objectives
Address performance issues promptly
Ensure compliance with company policies
Ensure compliance with regulatory requirements
Communicate decisions
and operational updates
and regulatory audits
Prepare documentation for audits
Ensure operational readiness for audits
Lead technical discussions
Lead project-related calls
Provide subject-matter expertise
Maintain and strengthen Quality System
Manage cleanroom operations
Ensure housekeeping standards
Ensure equipment cleaning
Review/sign-off cGMP records
Oversee equipment readiness
Coordinate scheduling and resource allocation
Drive continuous improvement initiatives
Provide shift or off-shift coverage
How You'll Work.
Team & Collaboration
Cross-functional coordination; Coordinate scheduling and resource allocation with leadership; Align diverse interests to drive complex decisions; Develop team capabilities through clear planning and communication
Communication Scope
Clearly communicate technical information to varied audiences; Communicate decisions, policies, and operational updates to personnel; Inspire stakeholders; Mentoring others in persuasive communication; Clear planning and communication
Process & Methodology
Manage multiple concurrent activities, Guide strategic projects, Set aligned objectives
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