Principal Scientist, QC

Company: Novo Nordisk A/S
Location: Bloomington
Posted on: February 11, 2025

Job Description:

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance - effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral AwardsThe 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 facility.The Position:This position 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.Essential Functions:
  • 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
  • Accurately completes routine and preventive maintenance on basic to moderately complex equipment
  • Actively participates in team meetings and/or training sessions
  • Other duties as assignedPhysical 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 conditions will be Heating Ventilation and Air Conditioned controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.Qualifications:
    • Education/Experience:
      • Bachelor's degree in science field with 7-9 years of experience, including 4 year GMP experience or regulated industry
      • Master's degree in science field with 4-6 years of experience, including 4 year GMP experience regulated industry
      • PhD in science field with 0-4 years of experience, 4 years GMP experience preferred or other regulated industry
      • General laboratory equipment experience, including micropipettes
      • Must be able to read and understand English-written job instructions and safety requirements
      • Preferred:
        • Strong understanding of analytical chemistry and 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)We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
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Keywords: Novo Nordisk A/S, Bloomington , Principal Scientist, QC, Other , Bloomington, Indiana