Manager Biomanufacturing, DownstreammRNA

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 263000 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.

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 projectrelated calls providing subjectmatter 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/signoff 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 offshift coverage as required
• Other duties as assigned

The Candidate:

• 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 cleanrooms aseptic techniques and general laboratory equipment in a GMP setting
• We will also accept a Masters degree with 4 years OR a Bachelors 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 crossdisciplinary data using broad biologics and drugdevelopment 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 crossfunctional 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 to further your career! Join the global drug development and delivery leader and help us bring over 7000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

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California Job Seekers can find our California Job Applicant Notice HERE.