Director, CMC Writing

Role Summary

Director, CMC Writing. Technical Development is hiring an experienced Director to join the Chemistry, Manufacturing, and Controls (CMC) Writing Center of Excellence to raise the bar for CMC technical narrative across our pipeline. You’ll partner with Process Development, Analytical Development, Manufacturing, MS&T, Quality, and CMC Regulatory to ensure data and technical strategy are transformed into crisp, phase-appropriate narrative for regulatory submissions. In this role, you will coach subject matter experts, build scalable standards for CMC strategic documents, and bring a modern, data-driven approach to how we author, review, and maintain CMC documentation. The ideal candidate will have extensive experience in process or analytical development in support of multiple successful BLA/MAA submissions, with clear and concise technical writing and a passion for employee development.

Responsibilities

• Serve as the principal CMC writing consultant, reviewer, and finalizer for high-impact deliverables, including CMC sections for regulatory submissions and responses to information requests.
• Work with subject matter experts (SMEs) to translate complex data into clear narratives and well-structured tables and figures, ensuring clarity, accuracy, and regulatory alignment prior to submission.
• Implement quality and efficiency metrics and drive continuous improvement.
• Champion digital/structured authoring techniques and evaluate the role of AI tools in the document lifecycle.
• Orchestrate the lifecycle and communication of key CMC strategy documents and decisions.
• Build and deliver technical writing curricula and hands-on coaching for SMEs and reviewers.
• Provide matrix leadership across teams and programs to drive consistency and upskilling across Technical Development.

Qualifications

• BS or MS with 15 to 20+ years of relevant industry experience, or PhD with 10 to 15+ years of relevant experience in CMC technical development (e.g., process or analytical development) and technical writing for regulatory submissions (e.g., INDs, BLAs).
• Extensive experience authoring, reviewing, and developing strategy for CMC sections for regulatory filings.
• Deep working knowledge of current regulatory guidance (e.g., ICH) and their application to CMC and submission strategy.
• Demonstrated ability to translate complex technical data and strategies into clear and compelling narrative aligned with regulator expectations and guidance.

Skills

• Hands-on background in Analytical Development (method development) and/or Process Development/MS&T (scale-up, tech transfer, PPQ) for biologics or nucleic-acid modalities (e.g., mRNA/LNP).
• Strong vision of excellence in CMC technical writing for regulatory submissions and a passion to educate and coach authors.
• Fluency with modern tooling (e.g., Veeva Vault, JMP, Spotfire, structured authoring) and comfort exploring AI-assisted authoring techniques.
• Proven matrix leadership and influence skills across cross-functional teams.
• Track record building training programs and coaching scientists to write with clarity.

Education

• Not specified beyond degree requirements in Qualifications.