Scientist I - Quality Control

Position Summary

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 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. 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.

The Scientist I - Quality Control performs routine testing of process samples, raw materials, finished products, and stability samples, while adhering to SOPs and working in a cGMP compliant environment. The Scientist I - Quality Control supports preventative maintenance and basic laboratory maintenance activities while maintaining a GMP quality system.

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

• Independently executes and properly documents cGMP Quality Control testing.

• Independently operates basic and moderately complex cGMP Quality Control equipment. Accurately completes routing and preventive maintenance on basic to moderately complex equipment.

• Assists in authoring technical documents such as SOPs and 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 inn TrackWise.

• Other duties as assigned.

The Candidate

• Master's Degree in Biology, Biotechnology, Chemistry, or related life sciences field, OR Bachelor's Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 3 years of industry experience, OR Associates Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 6 years of industry experience, OR 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.

• cGMP, Good Documentation Practices (GDP), Good Laboratory Practices (GLP) knowledge, and experience following standard operating procedures (SOP) preferred.

• General laboratory equipment experience, including micropipettes.

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning. Working conditions will be Heating Ventilation and Air Conditioned controlled.

Why You Should Join Catalent

• Several Employee Resource Groups focusing on D&I 

• Tuition Reimbursement – Let us help you finish your degree or earn a new one! 

• Generous 401K match 

• 152 hours accrued PTO + 8 paid holidays