Senior Scientist I

2 days ago

Watertown, Massachusetts, United States Novo Nordisk Full time

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
This is a position focused on late stage drug product development. You will be part of a team based in Watertown, MA and report to the manager of the drug product outsourcing group. 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.

Relationships

This is a position focused on late-stage drug product development. You will be part of a team based in Watertown, MA and report to the manager of the drug product outsourcing group. 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 process development, tech transfer and manufacturing scale-up activities of late stage small molecule drug productsEffectively 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.Successfully lead the process development as well as manufacturing of clinical batches at selected CDMO'sConduct process scale up and robustness studies according to a QbD setup (e.g. DoE) to support late stage and commercial manufactureConduct 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 and answer on 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. QualificationsPh.D. in Pharmaceutical Sciences or relevant technical field and 4+ years of productive, relevant work experience, or M.S. (or equivalent degree) and 8+ years of productive, relevant work experience. Minimum of 3+ years experience in managing development and manufacturing activities at CDMO's.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 process 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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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