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Senior Scientist I, QC - Method Validation - Madison Wisconsin
Company: Disability Solutions Location: Madison, Wisconsin
Posted On: 05/09/2024
Senior Scientist I - Quality Control, Method Validation.SummaryCatalent 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 market 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.Working for Catalent Biologics is an opportunity to join an entrepreneurial team.-- Catalent Biologics is making significant investments in people and capabilities.-- This is a unique opening to join a small, fast growing business, backed by a global public company.-- People joining our team will have the opportunity for career development as our business continues to grow and expand.-- Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.----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.The Method Validation team is responsible for analytical testing, data analysis, document writing, and data reporting to support phase-appropriate method validation of analytical methods. These methods directly support the Stability and Release and In-Process testing teams.This is a full-time on-site position, Monday - Friday 8am-4:30pm.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 Methods and testing.
- Authors technical documents such as SOPs and reports.
- Interacts as an SME for internal and external customers.
- Supports training of specific analytical techniques.
- 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.
- Performs self-review of analytical data and technical review of peers' analytical data for accuracy and consistency with SOP's.
- Actively participates in team meetings and/or training sessions.
- Other duties as assigned.The Candidate
- PhD Degree in Biology, Biotechnology, Chemistry or related life sciences field; OR
- Master's Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 4 years of industry experience; OR
- Bachelor's Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience; OR
- Associate Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 10 years of industry experience; OR
- High School Diploma or equivalent with a minimum of 11 years of industry experience
- Experience writing technical documents.
- Familiarity with clean room procedure, aseptic technique, and general lab equipment experience.
- cGMP, Good Documentation Practices (GDP) or Good Laboratory Practices (GLP) knowledge experience.
- HPLC, CE experience required, (icIEF) strongly preferred.
- Strong understanding of analytical chemistry and simple, moderately complex, and complex lab equipment.Physical Requirements
- 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 must be followed to minimize exposure, including proper use of PPE (personal protective equipment) and clean room gowning.
- Working conditions will be Heating Ventilation and Air Conditioned controlled.Why you should join Catalent:
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