Scientist - Quality Control, AQC

Scientist I, Quality Control Position Summary

• Work Schedule:
  
  M-F 8am-5pm
• 100% on-site

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.

Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Catalent Pharma Solutions in Madison, WI is hiring a Scientist I, Quality Control. The Quality Control (QC) team is responsible for testing products, raw materials and the manufacturing environment to ensure the Safety, Quality, Identity, Purity and Potency produced by the Catalent Madison Biologics facility. This position requires a variety of skills necessary for biotech company operations. Perform routine testing of process samples, raw materials, finished products and stability samples, while adhering to SOPs and working in a cGMP compliant environment.

Position will Analyze and interpret results in written and oral format. Additionally, this position will support Preventative Maintenance and basic Laboratory maintenance activities while maintaining a GMP quality system. Other duties will include data review/archiving, database entry/review and contributions to process improvement initiatives.

• Independently executes and properly documents cGMP Quality Control testing.
• Independently operates basic and moderately complex cGMP Quality Control equipment.
• Assists in authoring technical documents such as SOPs, reports.
• Performs self-review of analytical data for accuracy and consistency with SOP.
• Enters data into Laboratory Information Management System (LIMS) or laboratory reports.
• Performs general lab housekeeping in adherence to 5S standards.
• Initiates and assists with records in Trackwise.
• Accurately completes routine and preventive maintenance on basic to moderately complex equipment.
• Actively participates in team meetings and/or training sessions.
• Other duties as assigned.

• Master’s Degree in Biology, Biotechnology, Chemistry or related life sciences field
• Bachelor’s Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 3 years of industry experience
• Associate Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience
• High School Diploma or equivalent with a minimum of 7 years of industry experience

• Strong understanding of analytical chemistry and simple and moderately complex lab equipment preferred
• Familiarity with clean room procedure, aseptic technique, and general lab equipment experience preferred
• cGMP, Good Documentation Practices (GDP) or Good Laboratory Practices (GLP) knowledge preferred
• General laboratory equipment experience, including micropipettes preferred

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
  - Let us help you finish your degree or start a new degree!

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, confirmation of request, and include the job number, title and location to Disabili 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.