Disability Solutions - Madison, WI

posted 4 months ago

Full-time - Mid Level
Madison, WI
501-1,000 employees
Administrative and Support Services

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 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 employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer's. The Scientist II, Quality Control requires a variety of skills necessary for biotech company operations. The position will perform routine testing of process samples, raw materials, finished products, and stability samples, while adhering to SOPs and working in a cGMP compliant environment. The 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. Analytical testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product are also key components of this role.

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 and reports.
  • Coordinates with Supervisor to prioritize and schedule activities to meet deadlines.
  • Supports continuous process improvement initiatives.
  • 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 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.

Requirements

  • Master's Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 1 year of industry experience.
  • Bachelor's Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 4 years of industry experience.
  • Associate Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 8 years of industry experience.
  • High School Diploma or equivalent with a minimum of 9 years of industry experience.

Nice-to-haves

  • Strong understanding of analytical chemistry and simple and moderately complex lab equipment.
  • 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.

Benefits

  • 152 hours PTO & 8 Holidays
  • Medical, Dental & Vision Benefits
  • 401k
  • Tuition Reimbursement
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