The Lead QC Scientist- Microbiology (Method Services)
is responsible for supporting the method qualification program and cleaning validation for the QC Microbiology network. The successful candidate will have a strong background in Microbiology based assay development and familiarity with compendial requirements for testing in support of routine in-process and final product testing. In addition, the candidate should have extensive experience in data collection, statistical analysis, and the interpretation of data in the context of a GMP manufacturing process. The primary responsibility is supporting the development of validation protocols for compendial testing assays related to Bioburden, Endotoxin, Sterility, Conductivity, TOC, and other rapid detection methods.
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent?The Role:
- Technical writing of QC Microbiology protocols and reports to support the site testing programs.
- Determine cleaning indicators, calculate residual carryover limits, calculate surface areas for new and existing equipment, and collect cleaning validation samples (swab and rinse)
- Provides input on SOP revisions and may assist in the creation and editing of protocols and makes approved changes to documents (SOP's, test specifications, worksheets, material specifications); Coordinates testing activities and projects with laboratory staff. Schedules test/studies as applicable.
- Strong interpersonal, leadership and communication skills (both written and presentation), as well as the ability to function in a team environment are required; Advises clients on routine technical issues and participate in client meetings, and works with client to develop test specifications for routine testing.
- Participate in analyzing and interpreting results. Assure proper records and sufficient data are maintained on all testing and the research information is presented in a logical, methodical, comprehensive, conclusive, and scientifically sound manner.
- Prepare or participate in the preparation of controlled documents (protocols, test specifications, SOP's, Associated Documents, etc.) in conjunction with the requirements of the applicable standards and/or client instructions.
- May have to act as a Subject Matter Expert (SME) during audits and has the demonstrated ability to lead peers in the lab setting and during cross-functional projects
- Supervisory input focused on status and future of project or technical area and long-term development path
- Other duties as assigned
Why you should join Catalent:
- B.S. in a Life Sciences discipline and 9-12 years of relevant experience working in cGMP laboratory environments
- M.S. in a Life Sciences discipline and 6-8 years of relevant experience working in cGMP laboratory environments.
- PhD in a Life Science discipline and 3-5 years of relevant experience working in cGMP laboratory environments.
- Advanced knowledge of QC Microbiology in Biotechnology and Cell & Gene Therapy manufacturing; Advanced knowledge of Microbial identification practices in the industry, knowledge of Microbial assay validations and reporting, and knowledge of Cleaning Validation and reporting; Has the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
- Ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision with strong attention to detail and experience with Microsoft Excel and Microsoft Word
- Technical subject matter expert and oversight of established sterile products as well as new product introduction (NPI) related to Bioprocess.
- Experience with sterilization science related to development, validation and routine maintenance of sterile products and processes including terminal sterilization related microbiology and sterile barrier integrity testing as well as controlled environments and environmental monitoring a plus.
- Ability to support overtime routinely on the off-shift and over the weekend as needed.
Catalent offers rewarding opportunities to further your career!
- Potential for career growth within an expanding team
- Defined career path and annual performance review & feedback process
- Cross functional exposure to other areas of within the organization
- Medical, Dental, Vision, and 401K are all offered from day one of employment
- 19 days of paid time off annually + 8 paid holidays
- Gain experience in the cutting-edge gene therapy space
- Tuition Reimbursement
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.
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.
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