Manager, Microbiology, Cell Therapy Development - CAR-T Warren United States,
celgene is a global biopharmaceutical company leading the way in medical Innovation to help patients live longer, better lives. our purpose as a company is to discover and develop therapies that will change the course of human Health. we value our passion for patients, quest for Innovation, spirit of independence and love of challenge. with a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
manager, Microbiology, Cell therapy development - car-t
the manager, Microbiology works both independently and with the team to manage the general operation and workflow of the Microbiology function and perform routine and non-routine microbiological Testing and Microbiology Laboratory maintenance functions, where necessary.
- working independently, carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- ensure Compliance with current good manufacturing procedures (cGMP), usp, eu and other global regulatory requirements at all times, and have a deep understanding of usp, ep, jp, and FDA Microbiology Testing requirements.
- influence routine Testing strategies and Sampling requirements in support of regulatory submissions
- act as a technical lead on Microbiology test validations and method qualifications.
- develop environmental monitoring programs for Cell therapy product candidates.
- manage the day to day activities of the environmental monitoring team.
- follow directions well; work cooperatively as a team Leader, an individual contributor and as a team Member.
- responsible for maintaining the Laboratory test schedule for all Microbiology activities and delivery of results within established batch release timelines.
- perform duties of a qualified Trainer and assist department management with Employee Training, Qualification and professional development.
- prepare Microbiology employee task assignment schedules and allocation of resources to execute department required activities in support of Operations.
- ensure that schedules coordinate with other Operations across both qc and manufacturing, where necessary.
- central point of contact for all Microbiology-related inquiries.
- communicate effectively with peers, department management and cross-functional peers and management.
- document Laboratory test results on worksheets utilizing good Documentation practices.
- identify and execute continuous improvement projects for the department. lead and develop best practices in the Laboratory.
- using technical expertise troubleshoot and solve problems that may come up in the day to day operation of the department.
- capable of leading local cross-functional and global teams, as required.
- participate in Aseptic process qualifications, such as Aseptic gowning and media fills.
- prepare microbiological Testing media and perform Quality Control Testing of media used in the microbiological Testing of bulk pharmaceutical raw materials, in process and finished product, where required.
- perform and/or review routine microbiological Testing such as bioburden, bacterial endotoxin, and sterility Testing on in process and finished drug products.
- perform and/or review Quality Control Testing of incoming Laboratory reagents, microbiological Testing media, and Biological indicators, where required.
- perform final review of critical cGMP documents supporting batch release and controlled area status.
- under the guidance of management support special project work.
- perform and/or review microbial identification via Polymerase Chain Reaction (PCR)
- perform and/or review mycoplasma Testing via PCR
- perform and/or review microbial isolation techniques and perform gram stain identifications.
- author and revise controlled documents such as standard operating procedures and controlled forms. author non routine protocols in support of projects.
- initiate and perform deviation investigations/capa’s associated with microbiological Testing.
- interface with regulatory agency inspectors/auditors
- record and interpret data results.
- perform other duties as assigned.
- requires bachelor’s degree in Microbiology, Biotechnology, molecular biology, or related discipline and 10 years of experience working in Microbiology in a Pharmaceutical Manufacturing environment with team Leadership experience.
- an equivalent combination of experience/Education is acceptable.
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