Microbiologist
Position Summary
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.
Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology.
The Microbiologist is primarily responsible for performing complex, non-routine microbiological analyses, and therefore must be capable of recognizing the need for pathogen identification, solving microbiological system problems, and leading and completing microbial investigations related to the water system, environmental monitoring of production equipment and the air handling system. The Microbiologist will perform work that is “hands on” and maintains the microbial testing needed to support raw materials, finished goods and environmental monitoring for the facility.
Shift: 2nd (Monday -Friday, 4 pm – 12 am)
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
Proficiency with aseptic technique, microbiology laboratory skills and general laboratory safety.
Perform efficient/reliable microbial testing in accordance with USP/NF/EP/JP or customer guidelines. Typical testing may include microbial water analysis, chemical water analysis, product contact surface environmental monitoring, viable/nonviable air monitoring, and raw materials and finished goods Microbial Limits Tests.
Maintain accurate written records of all testing performed and accurately interpret and effectively communicate microbial results and issues.
Calibrate and maintain microbiology lab equipment.
Review, revise and/or write microbiology test methods and SOPs.
Perform peer review of microbiology testing and write up.
Lead investigations involving microbiological Out of Specification results.
Perform other duties as assigned.
The Candidate
Bachelor’s degree in microbiology, Biology or Chemistry is required. (Preferred in Microbiology or Biology)
·Work Experience in a Microbiology Laboratory, Clinical or Chemical Manufacturing role (including internships and co-op experience) is preferred.
Ability to communicate effectively.
Attention to detail.
·Basic knowledge of lab safety and the ability to work safely with microorganisms.
Working knowledge of cGMP regulations.
Working knowledge of aseptic technique and microbiology principles.
General computer literacy including use of Microsoft Word and Excel.
Accurately testing on the first attempt under pressure of production details.
Experience in the pharmaceutical industry or clinical microbiology preferred.
The candidate must wear safety glasses or specified eye protection in all designated areas, follow any applicable plant safety requirements, be fit-tested, trained, and capable of wearing an air-purifying respirator, and understand and practice aseptic techniques.
The candidate must be trained in hazardous material procedures and be able to lift up to 20 lbs.
Why You Should Join Catalent
Several Employee Resource Groups focusing on D&I
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
Generous 401K match
152 hours accrued PTO + 8 paid holidays
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 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.
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 spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.