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 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.
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 FunctionsLead quality control functions for GMP activities related to the production and release of Forma’s clinical trial materials and commercial productsReview and approve test methods, validation protocols and stability data from CMOs and CROsReview master and executed batch records for the manufacture of GMP suppliesManage change control processes/documentation related to GMP manufacturing, analytical methods, specifications and stability protocols per company SOPsLead investigations at external sites related to OOS/OOT, deviations, and unexpected analytical resultsCompile analytical testing data for raw materials, intermediates, drug substances and drug productsPerform trend analysis of testing data to set specifications for clinical and commercial drug substance and drug productsProvide strategic leadership and oversee Forma’s stability program. Conduct trend analysis with relevant software for all compounds in the portfolioAuthor and review IND/IMPD and NDA/CTA submissionsGenerate batch genealogy for clinical and commercial materials
Up to 15% travel to domestic and international contract manufacturing organizations as needed.
QualificationsM.S. in Life Sciences or related discipline with 10+ years of pharmaceutical industry experience or B.S. with 12+ years of experienceHighly experienced in leading quality control activities for drug development programs at CMOs and CROs for clinical and commercial productsStrong understanding of GMP requirements and regulations (ICH, EU, FDA) related to the manufacture and testing of drug substance and drug productExperience in setting GMP specifications, control strategies, and stability studies from early phase to commercializationExperience in authoring M3 sections of regulatory filings (IND/IMPD and NDA/CTA)Ability to manage multiple priorities in fast-paced drug development teamsStrategic thinker with good written and verbal communication skillsLate-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.