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Novo Nordisk · 4 days ago
Senior Scientist I - Formulation Lead
Watertown, MA
Full-time
Onsite
Senior Level
4+ years exp
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Responsibilities
Lead process development, tech transfer, and manufacturing scale-up activities of late-stage small molecule drug products
Interact with CDMOs to understand manufacturing requirements, equipment, and processes for drug product development
Conduct process scale-up studies and risk assessments to support late-stage and commercial manufacture
Collaborate with cross-functional teams to meet project goals, author regulatory submission documents, and support global filings
Apply innovative approaches to streamline drug product development activities and establish technical and business process flows
Train, mentor, and guide colleagues while supporting employee development initiatives
Qualification
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Required
Ph.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.
Benefits
Competitive compensation package
Support of a healthy work-life balance
Company
Novo Nordisk
Novo Nordisk is a healthcare company that produces and distributes insulin and other diabetes drugs to treat chronic diseases.
10,001+ employees
H1B Sponsorship
Novo Nordisk has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (11)
2022 (9)
2021 (9)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$22M2018-12-05Post Ipo Equity· $22M
1981-05-08IPO· nyse:NVO
Leadership Team
Lars Fruergaard Jørgensen
President and CEO
Lars Sorensen
President & CEO
Recent News
2024-06-06
2024-06-05
2024-06-05
Company data provided by crunchbase
