Principal Scientist, CMC Dossier Development
Johnson & Johnson
Principal Scientist, CMC Dossier Development
Johnson & Johnson is seeking a Principal Scientist for CMC Dossier Development to lead the creation of regulatory CMC dossiers for clinical and marketing submissions. The role involves coordinating timelines, providing technical oversight, and collaborating with cross-functional teams. Requires a PhD with 3+ years of experience or a Bachelor's/Master's with 6+ years, and experience in dossier authoring for synthetic or biologic products.
Principal Scientist, CMC Dossier Development
Johnson & Johnson is seeking a Principal Scientist for CMC Dossier Development to lead the creation of regulatory CMC dossiers for clinical and marketing submissions. The role involves coordinating timelines, providing technical oversight, and collaborating with cross-functional teams. Requires a PhD with 3+ years of experience or a Bachelor's/Master's with 6+ years, and experience in dossier authoring for synthetic or biologic products.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Preferred Qualifications
Technical (Nice-to-have)
Key Responsibilities
- Supports and implements dossier strategy/product development plans with autonomy.
- Leads dossier authoring activities for early and late-stage regulatory filings with some managerial support.
- Identifies and drives business improvements within the functional organization and collaborates with other departments as needed.
- Works with CMC/Tech team members, Regulatory, J&J Innovative Medicine Supply Chain, external service providers and internal Discovery, Product Development & Supply customers, as well as Global Clinical Operations and Therapeutic Areas.
- Collaborates with internal and some external partners, influencing alignment on new ideas and approaches.
- Combines technical expertise with managerial skills and may supervise consultants.
- Handles a limited number of standard projects or, with assistance, complex projects with accelerated priority.
- Challenges the status quo and identifies innovative process improvements.
- Makes day-to-day operational decisions and allocates resources, while working independently and checking in regularly with a supervisor.
- Leads functional or cross-functional teams of up to 10 members.