Senior Manager, QC
- Employer
- Novo Nordisk
- Location
- Bloomington, IN
- Start date
- Jan 28, 2025
View more categoriesView less categories
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
About the Department
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 Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The 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 Catalent Madison Biologics facility. The QC team is comprised of the following groups:
Microbiology: The Microbiology program ensures the safety of pharmaceutical products by testing solution(s), excipient(s), and finished products for disease-causing microorganisms. The Microbiology Program provides evidence-based and scientifically proven approaches and procedures that ensure sterility, determine antimicrobial effectiveness, detect microbial contamination/bioburden, and analyze endotoxins of manufactured product. In addition, the Microbiology Team collaborates with support groups to validate the assay methods used in testing finished products.
Environmental Monitoring: The Environmental Monitoring (EM) Program evaluates the effectiveness of microbial controls necessary to ensure that the manufacturing facility is maintained in a manner that prevents the ingress of microorganisms in low bioburden products. The EM program is part of an overall control strategy designed to ensure patient safety and incorporates facility design and maintenance, effective access controls, good cleaning procedures, validated sanitization, and disinfection procedures, reliable process controls, consistent sample collection and testing, an effective training program, and quality assurance of materials, facilities, and equipment.
Stability: Analytical testing, data analysis, document writing, and data reporting to support of ICH stability studies to determine the stability of bulk drug substance and drug product.
Release and In-Process: Analytical testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product.
Method Validation: Analytical testing, data analysis, document writing, and data reporting to support phase appropriate method validation of analytical methods. These methods directly support the Stability and Release and In-Process testing teams.
Sample Management: Management and oversight for all samples that support manufacturing, stability, and method validation. Also responsible for the management of stability chambers and oversight of laboratory critical reagents.
Raw Materials: Material inspection, sampling, analytical testing, data analysis, document writing, and data reporting to support the qualification and release of raw materials and components for use in the manufacturing of bulk drug substance and drug product.
Other functions: Additional functions within the Quality Control department include technical data review, training, instrument maintenance, lead investigator, and laboratory information management system (LIMS) administration. These functions directly support the entire Quality Control department perform their specific job functions.
The Position
Relationships
Reports to: Director or above
Direct Reports: 2-12
Essential Functions
Microbiology
Stability
Release and In-Process
Method Validation
Physical 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 condition controlled.
Qualifications
- Education/Experience:
- Bachelor’s degree in life sciences required 2 years laboratory experience or equivalent background
- 10 years GMP experience or other regulated industry
- 5-8 years of management experience
- Must be able to read and understand English-written job instructions and safety requirements
- Technical Requirements:
- Excellent written and verbal communication skills with internal and external customers
- Provides technical support to their direct reports
- Ability to communicate complex technical information to non-technical audiences
- Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution
- Maintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines
- Leads regulatory and client audits as a Subject Matter Expert
- Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process
- Experienced in most aspects of drug development and life cycle support, and able to develop useful strategies and tactics to meet regulatory milestones
- Well organized with ability to handle and direct multiple activities across departments simultaneously
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Company
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.
Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.
CONNECT
- Website
- https://www.novonordisk-us.com/
- Phone
- 617-612-6200
- Location
-
75 Hayden Avenue
Lexington
MA
02421
United States
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