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Senior Scientist, Qc

6+ years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Education: PhD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Scientist, QC
Location: Bloomington, United States
Job Category: Research

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About the Department

At Novo Nordisk, we aim to make a difference. For over 100 years, we've led the way in diabetes care, and working here provides employees the opportunity to embark on life-changing careers, improving the quality of life for millions worldwide.

Catalent, Indiana LLC, located in Bloomington, Indiana, is a cutting-edge facility offering an integrated model for biomanufacturing, clinical and commercial processes, drug product fill/finish, and packaging. This campus is a recognized site where talented teams collaborate with innovators to help develop, manufacture, and supply life-saving products.

What we offer you:

  • Competitive pay and annual performance bonus for all positions

  • Generous paid time off, including 14 paid holidays

  • Comprehensive Health, Dental, and Vision Insurance from day one

  • 8% guaranteed 401K contribution, plus individual match options

  • Family-focused benefits, including 14 weeks of paid parental leave and 6 weeks of paid family medical leave

  • Free access to Novo Nordisk-marketed pharmaceutical products

  • Tuition assistance, life, and disability insurance

  • Employee Referral Awards

Novo Nordisk offers numerous resources, mentorship, and growth opportunities to help you build your career. Ready to realize your potential? Join Team Novo Nordisk and help us make a difference.

The Role:

The Quality Control (QC) team tests products, raw materials, and manufacturing environments to ensure safety, quality, identity, purity, and potency. The team includes:

  • Microbiology: Microbial testing and data analysis

  • Environmental Monitoring: Ensures the manufacturing facility prevents microbial contamination

  • Stability: Conducts testing to determine the stability of bulk drug substances and drug products

  • Release & In-Process: Analytical testing and data analysis

  • Method Validation: Supports validation of analytical methods

  • Sample Management: Oversees sample management and critical reagents

  • Raw Materials: Material testing and release

The Position:

This role demands a variety of skills to support the testing of process samples, raw materials, finished products, and stability samples in a cGMP compliant environment. The position also involves equipment operation, technical documentation, data review, and preventative maintenance tasks, while adhering to GMP standards.

Essential Functions:

  • Execute and document cGMP QC testing independently

  • Operate basic to moderately complex cGMP QC equipment

  • Assist in authoring SOPs and technical reports

  • Prioritize tasks and meet deadlines in collaboration with supervisors

  • Contribute to process improvement initiatives and training

  • Review analytical data for accuracy

  • Maintain laboratory cleanliness following 5S standards

  • Perform equipment maintenance and follow safety protocols

Investigation Team:

  • Complete investigations via Trackwise, including non-conformance issues and root cause analysis

  • Ensure timely completion of corrective actions and preventive actions (CAPAs)

  • Coordinate with cross-functional teams for data collection and trend analysis

  • Lead or support deviation and trend CAPA activities

Physical Requirements:

  • Frequent sitting, standing, walking, and lifting (up to 50 lbs)

  • Occasional bending, kneeling, and use of lab equipment

  • Working with hazardous materials in a controlled environment with safety protocols

Qualifications:

  • Education/Experience:

    • Bachelor’s degree with 6 years of experience (2 years GMP experience)

    • Master’s degree with 2-4 years of experience (2 years GMP experience)

    • PhD with 2 years GMP experience

  • Experience with general lab equipment (micropipettes, etc.)

  • Strong understanding of analytical chemistry and lab equipment

  • Preferred:

    • Familiarity with cGMP, Good Documentation Practices (GDP), or GLP

    • Experience with aseptic techniques and lab safety procedures

Behavioral Requirements:

  • Strong communication skills

  • Time management and multi-tasking ability in high-pressure situations

  • Attention to detail and ability to work independently or within a team

  • Adaptability and critical thinking in problem-solving situations

Novo Nordisk is an equal opportunity employer and is committed to creating an inclusive culture that celebrates diversity in the workplace. If you require assistance with the application process, please contact us at 1-855-411-5290 for accommodations.