Associate Director - Quality Control

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’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 wi