Senior Scientist I – Quality Control

Catalent Pharma Solutions•Madison, WI

2d•Onsite

About The Position

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 Senior 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.

Requirements

PhD Degree in Biology, Biotechnology, Chemistry, or related life sciences field
Master’s Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 4 years of industry experience.
Bachelor’s Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 6 years of industry experience.
Associate Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 10 years of industry experience.
High School Diploma or equivalent with a minimum of 11 years of industry experience.

Nice To Haves

Strong understanding of analytical chemistry and simple, moderately complex, and complex lab equipment.
Experience writing technical documents.
Experience maintaining and troubleshooting Quality Control equipment.
Familiarity with clean room procedure, aseptic technique, and general lab equipment experience.
cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge.
Experience following standard operating procedures (SOP).
General laboratory equipment experience, including micropipettes

Responsibilities

Independently executes and properly documents cGMP Quality Control testing.
Independently operates basic, moderately complex, and complex cGMP Quality Control equipment.
Authors technical documents such as SOPs and reports.
Coordinates with Supervisor to prioritize and schedule activities to meet deadlines.
Supports continuous process improvement initiatives.
Interacts as an SME for internal and external customers.
Supports training of specific analytical techniques.
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 leads investigations or deviations in TrackWise.
Accurately completes routine and preventive maintenance on basic, moderately complex, and complex equipment.
Actively participates in team meetings and/or training sessions.
Other duties as assigned