Group Leader, Microbiology
The Group Leader role is critical to the Microbiology group and the incumbent will act as a primary technical lead interfacing with customers, writing protocols and communicating with the Microbiology Manager and other internal stakeholders to ensure incoming projects are ready to execute. The Group Leader, Microbiology will have Supervisory responsibilities including oversight to a group of 2 to 5 analysts.
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.
- Plan and perform method development/validation, routine microbiological testing (Microbiological Examination of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance.
- Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct of project activities and to assure project timeline understanding and deliverable are met, as appropriate.
- Function as a group lead and provide technical guidance to junior analysts.
- To maintain awareness of cGMP's, industry standards, modern techniques and their application to pharmaceutical sciences activities.
- Author and/or revise procedures/methods, as appropriate.
- Perform technical review and verification of peers' analytical data in accordance with SOP's.
- Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable.
- Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented.
- Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities.
- Other duties as assigned.
- Bachelor's of Science in Microbiology or closely related discipline with 8+ years of microbiology laboratory experience OR Master's Degree in Microbiology or closely related discipline with 5+ years of Microbiology experience
- Industry experience as a microbiologist, strong leadership and project management skills, and previous supervisory experience are desirable.
- On an average 8 hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds
- Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
- May require the use of a respirator
Why you should join Catalent:
- Competitive medical benefits and 401K
- 19 days of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
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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 DisabilityAccommodations@catalent.com. 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.
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