cGMP Biomanufacturing Manager
Position Summary
Due to a recent promotion we have a rare opening for a cGMP Biomanufacturing Manager. Now is the chance to gain unparalleled experience by working on multiple products and technologies. As the cGMP Biomanufacturing Manager you will be joining a dynamic team environment and enjoy a highly visible role within Catalent!
Requirements:
The Role
•The cGMP Biomanufacturing group is responsible for current Good Manufacturing Practices (cGMP) production activities, including Master/Working Cell Bank production, Upstream cell culture, Downstream protein/mRNA purification, and/or Fill/Finish. This position requires a variety of skills necessary for a cGMP Biomanufacturing environment. Independently perform Biomanufacturing operations, while adhering to SOPs and working in a cGMP compliant environment.
•Batch Production Record/data review, drafting technical documents protocols and reports, training/mentorship of (including contributions to performance management) staff and driving process improvement initiatives.
• The Manager will ensure responsiveness to the customer and overall, client satisfaction. The position will plan and monitor the progress and quality of projects by utilizing quality management tools available at Catalent
• The Manager will spend a portion of his/her 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 position will generally supervise up to ten direct reports
• Manages general cleanroom housekeeping, including room and equipment cleaning(s) and adherence to 5S standards
• Responsible for overseeing Tech Transfer into BioManufacturing
• Manage operation of Biomanufacturing equipment, such as, incubators, bioreactors (SUB), filtration equipment and controlled-rate freezers
• Manage small and large scale cell culture production of mammalian cell lines, such as cell counting, cell passaging, culture metabolite analysi s
The Candidate:
•PhD in Biotechnology, or related field, with minimum of 3 years experience in related laboratory work or related experience with demonstrated career progression including leadership responsibilitiesor M.S./M.A. in Biotechnology, or related field, with minimum of 5 years experience, B.S./B.A. in Biotechnology, or related field, with minimum of 7 years Associates Degree/Certificate/Diploma in Biotechnology. or related field minimum of 11 years experience in related laboratory work or related experience with demonstrated career progression including leadership responsibilities
•Clean room, aseptic technique, and/or general lab equipment experience
•cGMP, Good documentation practices (GDP), Good Laboratory Practices (GLP) knowledge
•Experience operating, maintaining and troubleshooting Biomanufacturing-related equipment
•Preferred Manager/Supervisory experience
•Preferred Experience with SUBs, SUMs, Unicorn and/or Delta V software(s)
•Preferred Experience with Trackwise, Compliancewire or other electronic tracking software
Position Benefits
•Competitive base salary with other compensation incentives
•Medical, Dental, Vision, and 401k are all offered on day one of employment
•19 days of Paid Time Off (PTO) + 7 paid holidays
•Defined career oath and annual performance review and feedback process
About Catalent
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.
