Job Description:The Director, CMC Analytical is responsible for executing the analytical development strategy to support NewAmsterdam Pharma's clinical-stage and late-stage development programs. The Director will provide strategic and technical leadership for analytical development, quality control, and regulatory support activities across the product lifecycle, registration-enabling activities, pre-commercial readiness, and potential post-approval lifecycle management. This role will oversee analytical activities for active pharmaceutical ingredients (API) and drug products (DP), ensuring robust support for manufacturing, regulatory submissions, inspection readiness, and future commercial supply. This position reports to the Executive Director, Analytical Development.
Responsibilities- Spearhead the strategic direction and execution of analytical development, quality control, and analytical lifecycle activities for active pharmaceutical ingredients (API) and drug products (DP), supporting programs through registration, launch readiness, and potential post-approval activities.
- Provide technical leadership and guidance to analytical development work, methods, and testing activities at CDMO
- Oversee the establishment of testing methodology, specifications, and stability programs for raw materials, intermediates, excipients, APIs and DPs including trend analysis, and retesting strategy
- Provide analytical leadership to support regulatory approval, commercial launch preparation, process validation, continued process verification, specification lifecycle management, and post-approval changes
- Oversee API and DP release and stability testing as well as analytical regulatory documentation to support global clinical studies, commercial product stewardship, lifecycle management, post-approval commitments, and regulatory filings
- Author, review, and strategically contribute to regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers)
- Author and review technical documents, staying abreast of industry trends, regulations, and best practices
- Drive the adoption of innovative technologies and quality-by-design (QbD) approaches
- Review and approve analytical methods, specifications, change controls, deviation, investigation, out-of-trend, or out-of-specification reports
- Work in close collaboration and support with other members of the CMC team responsible for API and DP development, as well as Clinical, Regulatory, Quality, Supply Chain, Technical Operations, and Commercial colleagues, to prioritize analytical activities across clinical-phase and commercial assets and support management as necessary
Qualifications- PhD in analytical chemistry or a related field with at least 12 years of analytical team leadership in the biotechnology or pharmaceutical industry
- Experience managing and building strong relationships with contract manufacturing organizations
- Experience in early and late-stage programs, commercialization, commercial product support, launch transition, post-approval commitments, and life cycle management
- Extensive technical expertise in analytical method development and validation for API and DP, characterization, and stability of solid oral dose
- Proficiency in reviewing and analyzing release and stability data for trending, shelf-life, and specification establishment
- Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability
- Proficient in writing RFPs, protocols, reports, and regulatory documents
- Exceptional interpersonal, negotiation, problem-solving, communication, and analytical skills
- Must be well-organized, proactive, and detail-oriented
- Demonstrates voracious intellectual curiosity, innovation, and creative problem-solving with an entrepreneurial spirit and a keen sense of urgency; can thrive in an agile environment
- Ability to thrive in a fast-paced, high-growth, matrixed startup biotechnology environment while balancing strategic thinking with operational excellence and hands-on execution across both clinical and commercial asset needs
- Project management skills including the ability to manage multiple projects; assess interpersonal relationships across multiple disciplines in product development; identify gaps that may impact critical milestones; assess, adjust, and maintain timelines as required by project needs; and evaluate project resources
- Strong verbal and written communication skills with an ability to build relationships internally and externally
- Willingness to travel to various meetings or client sites, domestically or internationally when necessary
- NAP has adopted an on-demand workplace philosophy. This remote role requires in-person attendance in the New England area based on business needs and work requirements rather than a set office schedule, with increased frequency during commercial launch planning and launch-related activities
Salary and Benefits:We offer a competitive base salary, annual bonus, and long-term incentives. In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.
