Supervisor, cGMP Biomanufacturing - Downstream/mRNA

Supervisor - Biomanufacturing, Downstream/mRNA

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Supervisor will oversee a team/shift responsible for Downstream manufacturing of biologics drug substance and mRNA & Molecular Therapeutics, supporting direct execution and providing leadership oversight. The Downstream/mRNA Biomanufacturing Supervisor will be responsible for his/her team’s execution of production activities including column chromatography, normal flow filtration / tangential flow filtration (TFF), viral reduction / filtration, in-vitro transcription (IVT), and bulk drug substance filling in a clinical and commercial cGMP environment. The Supervisor will be present on the floor to support execution in compliance with SOPs and GMP guidelines, provide coaching and development to employees, and drive a ‘right first time’ culture. The Supervisor will ensure batch manufacturing readiness, meet production schedule deliverables, drive a continuous improvement culture, support Person in Plant (PIP), and continually optimize staff and operating model in support of client program requirements and site financial objectives. The Supervisor will coordinate activities and drive standard work with Supervisors of other shifts. This position generally supervises 5-15 direct reports. The Supervisor spends the majority of time assigning, reviewing, checking work, assisting in the manufacturing suites and eliminating ordinary difficulties. This person also recommends candidates for hiring, termination, prepares and conducts performance reviews and salary reviews, and applies company policies.

This is a full-time on-site salaried position, Sunday - Wednesday, 2:00pm to 12:00am

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role: 

• Authors and revises Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aids (JA)
• Performs daily review and final sign-off of executed cGMP documentation (BPRs, forms)
• Supervises general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards
• Trains, monitors, and mentors direct reports on biomanufacturing activities; Mentors staff regarding regulatory requirements and supports operators with deviation management
• Holds 1x1s with employees; Leads team meetings and/or training sessions.  Acts as Subject Matter Expert (SME) on biomanufacturing activities
• Supervises completion of routine and preventive maintenance on biomanufacturing equipment; Supervises/executes equipment qualification/validation protocols, as required
• Supports deviation investigations and change control/protocol execution in a time sensitive fashion
• Drives and supports continuous process improvement initiatives.
• Other duties as assigned

The Candidate: 

• Must have Masters Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 2 year of relevant experience OR
• Bachelors or Associates Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 4 years of relevant experience OR
• High School Diploma with a minimum of 6 years of relevant experience
• GMP experience required
• 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
• Position requires 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 is required
• Must comply with EHS responsibilities for the position
• Individual may be required to lift and/or move 0-10 pounds frequently, and occasionally moving and/or lifting up to 50 pounds

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 paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement 

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 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 [email protected]. 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:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

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