Senior Scientist , Quality Control

Senior Scientist I, Quality Control (Data Review Team) Position Summary

• Work Schedule:
  
  Monday – Friday, core hours 8am-4pm
• 100% on-site (Madison, WI)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

The Senior Scientist I in the Quality Control (QC) data review team will be responsible for testing products, raw materials and the manufacturing environment to ensure Safety, Quality, Identity, Purity and Potency produced by the Catalent Madison Biologics facility. Other duties will include data review/archiving, database entry/review and contributions to process improvement initiatives.

• Performs self-review of analytical data for accuracy and consistency with Standard Operating Procedure (SOP). Enter data into Laboratory Information Management System (LIMS) or laboratory reports.
• 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.
• Leads continuous process improvement initiatives. Interacts directly with customers. Supports training of specific analytical techniques.
• Performs general lab housekeeping in adherence to 5S standards. Actively participates in team meetings and/or training sessions.
• Initiates and leads investigations or deviations in Trackwise. Accurately completes routine and preventive maintenance on basic, moderately complex, and complex equipment.
• Other duties as assigned.

• High School Diploma or equivalent with 11 years of industry experience is required. We will also accept the following experience and education (Biology, Biotech, Chemistry, or related field) combinations:
  Associate’s Degree and 10 years, Bachelor’s and 6 years, Master’s and 4 years, or a PhD without formal experience.
• Must have ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in clear and accurate language and according to SOP.
• Must be able to attend training and apply learning on routine operation, maintenance and theory or laboratory instrumentation, SOPs, and regulatory guidelines.
• Ability to peer review data to ensure data is well organized with complete documentation. Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions. Must have strong use of Excel, Word, and other office systems. Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy.
• Must be able to execute/monitor corrective action and independently apply GMPs to everyday work with regard to documentation and instrument use.
• Ability to apply regulatory authority and guidelines with training.
• Preferred experience with writing technical documents, maintaining and troubleshooting Quality Control equipment, and familiarity with clean room procedure, aseptic technique, and general lab equipment experience.
• Physical requirements: Individual must be able to see, hear, read, and write clear English. 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.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• 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,…