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Associate Director
4 months ago
About the Department
Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, 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. Our greater Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.
The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers. You'll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes, obesity and MASH treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we've cultivated a culture of fun, ingenuity and innovation. And our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. We are changing lives for a living. 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'sclinical 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 Physical Requirements 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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.