Fill/Finish Supervisor, cGMP Biomanufacturing
- Catalent Pharma, a leading CMO in the Biologics industry, is excited to announce that due to increased customer demand, our Biomanufacturing team is growing in Madison, WI. We are currently hiring for an experienced Fill/Finish Supervisor. The Fill/Finish Supervisor, cGMP Biomanufacturing will focus on providing floor leadership and supervision for all aseptic biomanufacturing personnel within our state of the art biomanufacturing facility.
The Fill/Finish Biomanufacturing Supervisor will independently perform biomanufacturing operations in a Class 1,000 (ISO 6) fill suite, while adhering to SOPs and working in a cGMP compliant environment. Other duties will include Batch Production Record and data review, drafting technical documents, protocols and reports, training/mentorship and performance management of up to 10 direct reports and driving process improvement initiatives. The role will also ensure that staff continues to be developed to keep pace with fill finish department goals and site growth.
The Role (daily responsibilities)
- Supervises cGMP Biomanufacturing production Fill/Finish activities
- Supervises operation of Biomanufacturing Fill/Finish equipment, such as, dosing pump, pneumatic crimper/capper
- Supervises vial and media filling operations under sterile working conditions
- Supervises vial inspection/labeling/packaging Supervises/Stages raw materials/components for use within cGMP Biomanufacturing
- Supervises completion of routine and preventive maintenance on Biomanufacturing Fill/Finish equipment
- Supervises/executes aseptic equipment qualification and validation protocols, as required
- Supervises media/solution preparation, as required
- Act as Subject Matter Expert (SME) on Fill/Finish Production activities
- Authors and revises Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aids (JA)
- Maintains effectiveness of Quality system
- Performs daily review and final sign-off of executed cGMP documentation (BPRs, forms)
- Leads team with deviation investigation activities, executes change controls and mentor/trains staff regarding regulatory requirements
- Supervises continuous process improvement initiatives
- Coordinates with senior leadership and management peers to prioritize and schedule activities to meet deadlines
- Develops department employees through orientation, training, establishment of objectives, communication of rules and policies while building employee morale and motivation.
- Maintains compliance with company policies, cGMP’s, safety standards, and good housekeeping practices.
- Works scheduled shift and other off-shift coverage as required to support team
- Other duties as assigned
The Candidate (requirements)
- Bachelor’s degree in Biotechnology, Microbiology or related field, with minimum of 6 years’ experience in related manufacturing role (Aseptic, Sterile Filling, Solutions, Finishing Operations in a cGMP regulated environment) with demonstrated career progression including leadership responsibilities; OR M.S./M.A. in Biotechnology, with minimum of 3 years’ experience; OR PhD in Biotechnology, or related field, with minimum of 2 years’ experience. In lieu of a completed degree, will additionally consider an Associate’s degree/HS Diploma and 8 years of experience managing related production processes with demonstrated career progression into a leadership role.
- Cleanroom and aseptic technique knowledge with specific expertise in validating aseptic manufacturing equipment and processes
- Excellent chemical handling and mathematical aptitude with the ability to assemble troubleshoot and perform minor repairs on manufacturing equipment.
- Aseptic gowning procedures required. Candidate must physically be able to wear clean room/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE is essential for the health and safety of employees.
- Potential for career growth within an expanding team
- Defined career path and annual performance review and feedback process
- Medical, Dental, Vision and 401K are all offered from Day One of employment
- 19 days of paid time off annually + 7 paid holidays
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.
Catalent. More products. Better treatments. Reliably supplied.™
Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.