Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Sr. Scientist, QC is responsible for supporting analytical method transfers and method qualifications between the Pre-Clinical and Process Development group and Quality Control (QC). The Sr. Scientist, QC must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

This position represents two available openings and will be removed once all openings have been filled.

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:

• Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis; Generate internal and external documents such as assay protocols, summary reports, and SOPs
• Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns; Analytical support to AD for qualification/validation of test methods; Supports release and stability testing for raw materials, components, standards, intermediate/finished products; Generate internal and external documents such as assay protocols, summary reports, and SOPs
• Reviews laboratory work and approves data packages as designated by the Supervisor; Provide instrumentation care, maintenance, troubleshooting, and data interpretation; Responsible for document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending; Conducts second person review of in-process and water sample testing; Completes review of paper documents as well as review of electronic records
• Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS results and participating in associated laboratory investigations, reporting instrument issues and assisting with troubleshooting, etc.)
• Train new staff in scientific concepts, Analytical methods and assay testing, safety, and Good Manufacturing Practice; Actively participates in training activities, managing individual training plan
• Responsible for contributing to and/or handle laboratory investigations for events and OOS results.
• Eligible to apply for the Qualified Trainer (QT) Program.
• Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation; Work under limited supervision to meet project goals; Flexibility in following unique campaign requirements that may include off-hour and weekend work
• Other duties as assigned

The Candidate:

• Bachelor in a Life Sciences discipline with 4 – 6 years of experience working in a cGMP QC laboratory.
• OR
• Masters’ in a Life Sciences discipline with 2 – 4 years of experience working in a cGMP QC laboratory.
• HPLC knowledge/experience required; Experience with ELISA testing preferred but not required.
• Knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology; Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in QC function with a strong familiarity of general GMP practices; Experience in writing SOPs; Broad experience with biochemistry, as well as generating/reviewing the documentation that supports such work
• Proficient knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks
• Experience with Microsoft Excel and Microsoft Word
• Strong attention to detail and strong organizational skills; Ability to succeed in a team-oriented environment under very dynamic conditions; Must have the ability to work an available set shift. There will be times when overtime is required.

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.

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:

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California Job Seekers can find our California Job Applicant Notice HERE.