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.
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