The Scientist, QC Analytical is responsible for supporting analytical testing in order to support GMP manufacturing for both clinical and commercial clients. The Scientist, QC must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

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. 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.

Shift: Wednesday-Saturday 3pm-2am

The role:

• Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, and pH

• Documenting testing per GMP/GDP procedures

• Generate internal and external documents such as assay protocols, summary reports, and SOPs

• Analytical support to QC method services of method verification of platform test methods

• Supports release and stability testing for raw materials, components, standards, intermediate/finished products

• Generate internal and external documents such as 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

The candidate:

• Bachelor in a Life Sciences discipline with 2 – 4 years of experience working in a cGMP QC laboratory.

• Masters’ in a Life Sciences discipline with 0 – 2 years of experience working in a cGMP QC laboratory.

• Experience with any of the following techniques is preferred ELISA, qPCR, ddCPR, HPLC,CE

• 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

Why you should join Catalent:

• Competitive medical benefits and 401K

• 152 hours 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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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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