Principal Scientist, Qc

7-9 years

Not Disclosed

Bloomington

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

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

About the Department
At Novo Nordisk, we have led the way in diabetes care for over 100 years. Our work allows employees to embark on life-changing careers, improving the quality of life for millions of people worldwide. Catalent, Indiana LLC., located in Bloomington, is a state-of-the-art facility that integrates process, formulation, clinical, commercial biomanufacturing, and drug product fill/finish and packaging. We pride ourselves on being a top-notch facility, helping to develop, manufacture, and supply products to patients globally.

What We Offer You:

Leading pay and annual performance bonuses
Generous paid time off, including 14 paid holidays
Health, dental, and vision insurance from day one
8% 401K contribution plus individual company match option
Family-focused benefits including paid parental and medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition assistance
Life & disability insurance
Employee referral awards

Position Overview
As part of the Quality Control (QC) team, this position requires testing process samples, raw materials, finished products, and stability samples while adhering to SOPs and working in a cGMP-compliant environment. Responsibilities include analyzing and interpreting results, supporting maintenance activities, and contributing to process improvement initiatives.

Key Relationships:

Reports to: Senior Manager, Quality Control

Essential Functions:

Execute and document cGMP Quality Control testing independently
Operate basic to moderately complex cGMP Quality Control equipment
Author technical documents like SOPs and reports
Prioritize and schedule activities with the Supervisor to meet deadlines
Support continuous process improvement and training of specific analytical techniques
Perform self-reviews of analytical data for accuracy and consistency with SOPs
Enter data into the Laboratory Information Management System (LIMS)
Maintain laboratory cleanliness according to 5S standards
Participate in investigation teams and root cause analysis
Support corrective and preventive actions (CAPAs) related to trends

Physical Requirements:

Frequent sitting, standing, and walking
Occasional lifting of up to 50 pounds
Working conditions will include lab environments with potential exposure to irritants and hazardous materials

Qualifications:

Education/Experience:
- Bachelor’s degree in science (7-9 years experience, including 4 years in GMP or regulated industry)
- Master’s degree (4-6 years experience, including 4 years in GMP)
- PhD (0-4 years experience, 4 years GMP preferred)
- Familiarity with clean room procedures and aseptic techniques preferred

Technical Skills:

Strong understanding of analytical chemistry and complex lab equipment
Proficient in conducting QC laboratory testing
Experience in investigations and CAPA development

Behavioral Requirements:

Adaptable, analytical, and decision-making skills
Effective communication and time management
Ability to multi-task in a fast-paced environment

Inclusive Recruitment Process:
Novo Nordisk celebrates diversity in its employees, patients, and communities. We are committed to creating an inclusive culture and offer equal opportunities for all applicants. If special assistance or accommodations are needed, please contact us at 1-855-411-5290.

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 law.

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Principal Scientist, Qc

Job Description

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