Scientist I - Quality Control (2nd shift)

Catalent • Madison, WI

3d • Onsite

About The Position

Catalent Biologics is a rapidly expanding division of Catalent Pharma Solutions, dedicated to advancing biologic treatments for patients through innovative technologies and solutions. This includes their GPEx cell line engineering platform, a new biomanufacturing facility in Madison, WI, and leading biologics analytical services in Kansas City, MO, Research Triangle Park, NC, and SMARTag Antibody Drug Conjugate technology in Emeryville, CA. The Scientist I, Quality Control position at Catalent Pharma Solutions in Madison, WI, is part of a team responsible for testing products, raw materials, and the manufacturing environment to ensure the Safety, Quality, Identity, Purity, and Potency of products from the Catalent Madison Biologics facility. This role requires diverse skills for biotech operations, involving routine testing of process samples, raw materials, finished products, and stability samples in a cGMP compliant environment, adhering to SOPs. The Scientist I will analyze and interpret results, support preventative and basic laboratory maintenance, and uphold a GMP quality system. Additional duties include data review/archiving, database entry/review, and contributing to process improvement initiatives.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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.

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees