Project Manager - Formulation Lead

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

Do you have experience in drug development? Are you looking for an opportunity to apply your project management and negotiation skills to exciting challenges? Do you want to play a key role in supporting an ambitious drug development pipeline at Novo Nordisk benefitting millions of patients world-wide? If yes, then you might be our new Project Manager – Formulation Lead, Apply today! This is your chance to be part of many activities for drug product manufacturing processes.

The Drug Product function is part of Emerging Technologies business unit. The Emerging Technologies unit is a newly established area within 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 organization 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.

Relationships

This is a hybrid position. You will be part of a team based in Watertown, MA and report to the executive director for drug development. The team collaborates with other Boston-based teams on bringing key products to market including Drug Substance, Analytical Sciences, Supply Chain, Quality Control, Regulatory, and Project Management. Externally, this position interacts with Contract Development and Manufacturing Organizations (CDMOs) for the development of drug product, manufacturing, testing, and release of GMP Clinical Trial Materials (CTM) and commercial products ensuring all appropriate cGMP guidelines and regulations are met. The Drug Product group in Boston, US is a core pillar of our dynamic CMC drug development team. This role is critical in development of assets in our rare-disease and small molecule portfolio in collaboration with Denmark based departments. The position offers you exciting challenges as well as broad organizational exposure. You will experience a high degree of responsibility and visibility across the business unit.

Essential Functions

• Lead development and manufacturing of pediatric drug products
• 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
• 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

Hybrid – Primarily at Boston site and partial remote working per week. Up to 20% travel to domestic and international contract manufacturing organizations as needed.

Qualifications

• Ph.D. in Pharmaceutical Sciences or relevant technical field with 6-8 years of productive, relevant work experience, or M.S. (or equivalent degree) with 8-10+ years of productive, relevant work experience. Minimum of 3-5 years experience in managing outsourced development and manufacturing activities
• A proven track record in developing and scaling up formulations and process for oral administration from pre-IND through late-stage development and commercialization
• Expertise and direct knowledge in pediatric formulation 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/MAA authoring experience
• 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 complex, inter-disciplinary global organization while remaining flexible, proactive, resourceful and independently multitask. Fluent in oral and written English. Additionally, enjoy taking the lead while also being a valuable team player
• Experienced in writing, reviewing, and approving CMC sections of regulatory filings from early-stage development through commercial launch for global filings
• Experience in establishing new methods, systems and processes to improve department and product development approach

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.