Lead QC Scientist – Analytical is responsible for routine QC testing on cleaning, in-process and release samples. The QC Scientist must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

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 routine testing such as filter integrity testing, TOC, pH, conductivity and HPLC. Experience with ELISA testing preferred but not required.
• Perform assays such as qPCR, RT-PCR and ddPCR, ELISA, DNA/RNA extraction, Western Blot, gel electrophoresis, HPLC and Capillary Electrophoresis
• Provide instrumentation care, maintenance, troubleshooting, and data interpretation
• Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured
• Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
• Ensures compliance with cGMP and safety requirements within the QC analytical laboratory
• Participates in project specific, system, client, and vendor audits
• Maintains QC analytical laboratories and facilities in an audit ready status at all times.
• Other duties as assigned

The Candidate

• Bachelor in a Life Sciences discipline and 5 or more years of experience working in a QC laboratory (will consider reduced experience with increased levels of education in same field)
• Considerable 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 a Quality Assurance/QC function with a strong familiarity of general GMP practices
• Experience in writing SOPs and test methods as well as method qualification/validation documentation
• Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work
• Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks
• Ability to succeed in a team-oriented environment under very dynamic conditions

Why You Should Join Catalent

• 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

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.

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