Associate Director - Quality Control

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

 

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 can