Supervisor - Biomanufacturing, Downstream/mRNA

About the role

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 The Candidate: High School Diploma minimum is required plus a minimum of 6 years of relevant experience in a GMP setting We will also accept a Master's degree with 2+ years OR a Bachelor's degree with 4+ 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 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. 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 152 hours of PTO + 8 paid holidays Generous 401K match Medical, dental and vision benefits Tuition Reimbursement - Let us help you finish your degree or start a new degree! Catalent offers rewarding opportunities