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Associate Director - Quality Control

Employer
Novo Nordisk
Location
Watertown, MA
Start date
Nov 8, 2023

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

About the Department   

As a part of Novo Nordisk’s Strategy and Rare Disease organization, the Forma team is focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Its R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Forma’s Pharm Sci and QA team is focused on activities supporting clinical supply chain, drug formulation & manufacturing, and GMP, GCP, auditing in support of Sickle Cell Disease (SCD) programs. We’re looking for individuals who are enterprise thinkers, inclusive leaders, and strong collaborators, as we embark on shaping our future. Are you ready to make a difference?

 

The Position

The Analytical Sciences and Quality Control group is a core pillar of our dynamic CMC drug development team. This role is critical in development of assets in our rare-disease, small molecule portfolio.

 

Relationships

Reporting to the Director, Analytical Sciences, this position works closely with other functions in CMC drug development including Drug Product, Drug Substance, Supply Chain, and Quality Control. Externally, this position interacts with CMOs and CRO’s to lead and manage analytical development activities for clinical candidates in our pipeline.

 

Essential Functions

  • Lead quality control functions for GMP activities related to the production and release of Forma’s clinical trial materials and commercial products
  • Review and approve test methods, validation protocols and stability data from CMOs and CROs
  • Review master and executed batch records for the manufacture of GMP supplies
  • Manage change control processes/documentation related to GMP manufacturing, analytical methods, specifications and stability protocols per company SOPs
  • Lead investigations at external sites related to OOS/OOT, deviations, and unexpected analytical results
  • Compile analytical testing data for raw materials, intermediates, drug substances and drug products
  • Perform trend analysis of testing data to set specifications for clinical and commercial drug substance and drug products
  • Provide strategic leadership and oversee Forma’s stability program. Conduct trend analysis with relevant software for all compounds in the portfolio
  • Author and review IND/IMPD and NDA/CTA submissions
  • Generate batch genealogy for clinical and commercial materials
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    Physical Requirements

    Up to 15% travel to domestic and international contract manufacturing organizations as needed.

     

    Qualifications

  • M.S. in Life Sciences or related discipline with 10+ years of pharmaceutical industry experience or B.S. with 12+ years of experience
  • Highly experienced in leading quality control activities for drug development programs at CMOs and CROs for clinical and commercial products
  • Strong understanding of GMP requirements and regulations (ICH, EU, FDA) related to the manufacture and testing of drug substance and drug product
  • Experience in setting GMP specifications, control strategies, and stability studies from early phase to commercialization
  • Experience in authoring M3 sections of regulatory filings (IND/IMPD and NDA/CTA)
  • Ability to manage multiple priorities in fast-paced drug development teams
  • Strategic thinker with good written and verbal communication skills
  • Late-stage/NDA and commercial experience in quality control activities at CROs and CMOs is strongly preferred
  •  

    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.

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    Company info
    Website
    Telephone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

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