Senior Scientist, Qc

5+ years

Not Disclosed

Bloomington United States

10 Feb. 13, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Scientist, Quality Control

Location: Bloomington, United States
Job Category: Research

About the Department

At Novo Nordisk, we strive to make a difference. For over 100 years, we have led the way in diabetes care. Being part of Novo Nordisk provides employees with the opportunity to embark on life-changing careers and help improve the quality of life for millions worldwide.

As part of Novo Nordisk, Catalent, Indiana LLC in Bloomington, Indiana, is a state-of-the-art facility with an integrated model spanning process and formulation to clinical and commercial biomanufacturing, drug product fill/finish, and packaging. Our Bloomington campus is a recognized facility where talented teams collaborate with innovators to develop, manufacture, and supply products to patients globally.

What We Offer You

Competitive Compensation: Leading pay and annual performance bonus for all positions.
Generous Paid Time Off: Includes 14 paid holidays.
Comprehensive Benefits Package: Health, Dental, and Vision Insurance – effective from day one.
Retirement Benefits: Guaranteed 8% 401K contribution plus individual company match options.
Family-Focused Benefits: 14 weeks paid parental leave & 6 weeks paid family medical leave.
Employee Perks: Free access to Novo Nordisk-marketed pharmaceutical products.
Education Assistance: Tuition assistance available.
Additional Coverage: Life & Disability Insurance.
Referral Awards: Employee referral bonuses.

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Join Team Novo Nordisk and help us make what matters.

Quality Control (QC) Overview

The Quality Control (QC) team ensures the safety, quality, identity, purity, and potency of products, raw materials, and the manufacturing environment. The QC team is divided into several key groups:

1. Microbiology

Performs microbial enumeration and endotoxin testing.
Conducts data analysis and reporting to support manufacturing and product release.

2. Environmental Monitoring

Evaluates microbial controls to maintain a contamination-free manufacturing facility.
Performs routine and investigational sampling of the manufacturing environment.

3. Stability

Conducts analytical testing, data analysis, and document writing.
Supports ICH stability studies for bulk drug substances and drug products.

4. Release and In-Process Testing

Performs analytical testing and data reporting for bulk drug substance and drug product release.

5. Method Validation

Supports phase-appropriate validation of analytical methods.
Directly assists Stability and Release and In-Process teams.

6. Sample Management

Oversees sample management for manufacturing, stability, and method validation.
Maintains stability chambers and laboratory critical reagents.

7. Raw Materials

Inspects, samples, and tests raw materials.
Supports the qualification and release of raw materials and components.

8. Additional Functions

Technical data review, training, instrument maintenance, lead investigation, and LIMS administration.

The Position

This role requires expertise in various biotech operations. The scientist will perform routine testing of process samples, raw materials, finished products, and stability samples, adhering to SOPs and working in a cGMP-compliant environment. Responsibilities include data analysis, documentation, preventative maintenance, and process improvement initiatives.

Relationships

Reports to: Manager, QC

Essential Functions

Execute and document cGMP Quality Control testing independently.
Operate basic and moderately complex cGMP Quality Control equipment.
Assist in authoring SOPs and technical reports.
Prioritize and schedule activities to meet deadlines.
Support continuous process improvement initiatives.
Train on specific analytical techniques.
Enter data into LIMS or laboratory reports.
Perform general lab housekeeping in adherence to 5S standards.
Initiate and assist with records in TrackWise.
Complete routine and preventive maintenance on lab equipment.
Participate in team meetings and training sessions.
Perform other duties as assigned.

Investigation Team Responsibilities

Lead and complete investigations using TrackWise.
Coordinate immediate actions with QA and department management.
Interview SMEs and involved employees for problem assessment.
Conduct investigational meetings and utilize problem-solving techniques.
Develop and track corrective and preventive actions (CAPAs).
Present Major or Critical Deviations to the Deviation Review Board (DRB).
Support data collection for management reviews, KPI reports, and trend analysis.

Physical Requirements

Frequent sitting, standing, walking, reading, and computer use.
Occasional stooping, kneeling, bending, carrying, and grasping.
Frequent lifting up to 10 lbs; occasional lifting up to 50 lbs.
Compliance with EHS responsibilities.
Exposure to irritants, toxic materials, electrical equipment, and hazardous waste.
Strict adherence to safety procedures, including cleanroom gowning.

Qualifications

Education & Experience

Bachelor’s degree in science field + 5 years experience (including 2 years GMP experience).
Master’s degree in science field + 2 years experience (including 2 years GMP experience).
PhD in science field + relevant experience (including 2 years GMP experience).
Experience with general lab equipment, including micropipettes.
Must be able to read and understand English-written job instructions and safety requirements.

Preferred Qualifications

Strong analytical chemistry knowledge and lab equipment experience.
Familiarity with cleanroom procedures, aseptic techniques, and cGMP, GDP, or GLP regulations.
Experience following standard operating procedures (SOPs).

Technical Skills

Proficiency in all technical aspects of a Scientist role.
Root cause analysis and implementation of CAPAs.
Mentorship and leadership in the QC organization.
Management of process improvement projects.
Cross-functional collaboration and problem-solving expertise.

Behavioral Competencies

Strong communication, analytical, and problem-solving skills.
Ability to work effectively under pressure with multiple deadlines.
Positive attitude, teamwork, and adaptability.
Strong organizational and multitasking abilities.

Diversity & Inclusion Commitment

Novo Nordisk is dedicated to creating an inclusive culture that celebrates diversity. We believe in equal opportunity and are committed to recruiting and hiring a diverse workforce.

Equal Opportunity Employer: Qualified applicants will be considered without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, veteran status, or any other protected characteristic.

For special assistance or accommodations, call 1-855-411-5290 (for accommodation requests only; not for application inquiries).

Join us in making a difference. Apply today!

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