Associate Director - Formulation Development

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

Hybrid – Primarily at Watertown, MA site with remote flexability. The Drug Product group is a core pillar of our dynamic CMC drug development team. This role is critical in the development of assets in our rare-disease, small molecule portfolio.

Relationships

Reporting to the Executive Director, Drug Product, this position works closely with other functions in CMC drug development including Drug Substance, Analytical Sciences, Supply Chain, and Quality Control. Externally, this position interacts with Contract Development and Manufacturing Oranizations (CDMOs) for the development of drug product, manufacturing, and release of GMP Clinical Trial Materials (CTM) ensuring all appropriate cGMP guidelines and regulations are met

The Drug Product function is part of Emerging Technologies business unit. The Emerging Technologies is a newly established area in Novo Nordisk and is responsible for our growing pipeline of new products. We are handling and setting the strategic direction for the product portfolio based on emerging technology platforms coming into Product Supply via internal development projects and externally acquired assets. Together with stakeholders across the organisation and our local ET project offices, we ensure successful execution of the portfolio from late phase development to launch and market production. 

We are well-known for having a pioneering spirit as well as a curious and daring approach. We play a key role in developing and producing future treatments for millions of patients around the world. The ET area is anchored in Product Supply, Quality & IT (PSQIT), which globally employ approximately 25,000 of Novo Nordisk’s more than 57,000 employees.

Essential Functions

• Lead development and manufacturing of oral adult and pediatric drug products for New Chemical Entities’ (NCE’s) and in-licensed molecules. Serve as DP representative on CMC project team and other project team meetings.
• Effectively interact with CDMOs to understand the product manufacturing requirements, the necessary equipment, facility, and process support technologies required from CDMO’s to conduct drug product development and manufacturing of products. Successfully lead the formulation and process development as well as manufacturing of clinical batches at the selected CDMO’s.
• Serve as DP representative on due diligence teams and conduct DP technical assessment of assets. Support project and site integration activities.
• Develop phase appropriate solid and liquid dosage forms for adult and pediatric programs for clinical Phase 1, 2, and 3 studies.
• Conduct process scale up and robustness studies according to a QbD setup (e.g. DoE) to support our cutting-edge development and have digital transformation in mind.
• Conduct risk assessments/FMEAs through process development to DP process validation. Lead technical transfer of manufacturing process to commercial manufacturing site.
• Identify key stake holders and work collaboratively with cross-functional CMC, commercial, quality, regulatory, project management, legal, sourcing, supply chain and other functions to meet project goals
• Author DP sections in regulatory submission documents and support global filings
• Author technical reports and present at various technical and management meetings
• Apply innovative approaches to streamline DP development activities and establish technical and business process flows/ guidelines to support portfolio and organization changes.
• Train, mentor and guide colleagues and support employee development initiatives.

Physical Requirements

Up to 20% travel to domestic and international contract manufacturing organizations as needed.

Qualifications

• Ph.D. in Pharmaceutical Sciences or relevant technical field with 8+ years of productive, relevant work experience, or M.S. (or equivalent degree) with 12+ years of productive, relevant work experience.
• Minimum of 3-5 years of experience managing outsourced development activities
• A proven track record in developing and scaling up formulations for oral administration from pre-IND through late-stage development
• Expertise and direct knowledge in pediatric formation development
• Experience in formulation development of poorly soluble (BCS Class II/IV) compounds (small molecules)
• Extensive knowledge and hands on experience with equipment and processes commonly used for solid and liquid oral formulation development
• Experience in large-scale commercial manufacturing and NDA authoring experience will be a plus
• Sound knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales
• Excellent project management and communication skills Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient Experienced in writing, reviewing, and approving CMC sections of regulatory filings from early-stage development through commercial launch

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.