- Lead and manage external API development and manufacturing activities
- Responsible for phase-appropriate process development and implementation of control strategies for regulatory starting materials, intermediates and APIs
- Proactively work with CDMOs to manage process development and manufacturing of intermediates and API
- Lead fate and purge studies and mutagenic impurity evaluation
- Support PAR, DOE studies and validation activities for drug substance
- Review and approve development reports, master batch records, validation protocols/reports and specifications required for drug substance manufacturing
- Lead technical transfers of intermediate/API processes and support external manufacturing activities
- Work with quality assurance to manage the release of GMP drug substance and resolve technical issues or deviations
- Author and review relevant CMC sections for US and ex-US regulatory filings, including NDAs
- Work cross-functionally to communicate timelines, objectives, and updates
- Ph.D. in Organic Chemistry or Chemical Engineering with 8+ years of relevant experience or MS with 10+ years of relevant experience in the pharmaceutical industry
- Proven track record in process development, and multi-kilogram scale manufacturing
- Experienced in Design of Experiments, and other tools in the Quality by Design paradigm
- Successful track record in NOR/PAR/CPP studies
- Thorough understanding of the drug development process, including working knowledge in the areas of formulation and DP process development
- Strong understanding of cGMP requirements and regulations for clinical and commercial CMC drug development
- Proficiency with typical analytical tools (NMR, UV, IR, HPLC, MS)
- Ability to manage multiple projects and rapidly adapt to changing program needs
- Ability to manage multiple priorities in fast-paced drug development teams
- Attention to detail
- Excellent verbal and written communication skills
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Associate Director - Watertown, United States - Novo Nordisk
Description
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
Support and manage expanding needs of chemical development and external manufacturing in early- to late-stage development.
Relationships
The selected individual will report to the head of Chemical Development – Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality Assurance, and Supply Chain. Externally, the selected individual will interact with Contract Development and Manufacturing Organizations (CDMOs) for the development and manufacture of starting materials, intermediates, and API.
Opportunities for mentoring and management of direct reports are also possible.
The Chemical Development – Boston Team belongs to the External Chemical Development Department which is part of the larger Chemical Development organization anchored in Denmark.
Essential Functions
Physical Requirements
Up to 20% travel to domestic and international contract development and manufacturing organizations as needed.
Qualifications
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.
