Principal Scientist, CMC Dossier Development

Job Description:

The Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development, with some managerial guidance, develops the technical eCTD sections for Regulatory CMC dossier applications, coordinating and providing technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. Coordinates the timeline, virtual document and Quality module generation, while assuming ownership and accountability for business results and solutions. Represents the department on multi-functional project development teams to support regulatory filings and authors/drives sections of the CMC dossier ensuring compliance with regulatory requirements.

The Principal Scientist supports technical functions in developing responses to health authority inquiries for clinical trials and marketing applications, ensuring the completeness, accuracy and compliance of data provided for all regulatory submissions. Ensures timely completion of Quality submissions.

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.

Qualifications

Education:

• PhD with 3+ years of relevant post-doc experience OR Bachelor's or Master's degree in chemical, biological or pharmaceutical sciences or related fields with 6+ years of relevant experience is required.

Experience and Skills:

• Experience with dossier authoring for synthetic and/or biologic products, with expertise in both or evidenced capacity and willingness to expand knowledge and leadership across modalities is required.
• Familiarity with CMC (Chemistry, Manufacturing, and Controls) regulatory submissions, eCTD format, and relevant regulatory guidelines (e.g., FDA, EMA) is preferred.
• Experience handling complex projects, preferably in the pharmaceutical or biotech industry, with a focus on regulatory submissions is preferred.
• Experience in writing or leading all aspects of the preparation of regulatory CMC documents, including CMC sections for marketing and clinical trial submissions is preferred.
• Experience collaborating with various departments and external partners in a multi-disciplinary environment is preferred.
• Ability to develop and implement strategic plans related to dossier development and product timelines is preferred.
• Skills in leading teams or projects, mentoring colleagues, and coordinating resources effectively is preferred.
• Excellent written and oral communication skills with the ability to communicate complex technical information to diverse partners is required.
• Strong analytical and problem-solving abilities to identify and implement business improvements and innovations is required.
• Ability to work independently, handle multiple priorities, and adapt to changing project needs is required.

Hybrid work