Director, CMC Analytical

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.
• Athorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability.
• Proficiency in writing RFPs, protocols, reports, and regulatory documents.
• Exceptional interpersonal, negotiation, problem-solving, communication, and analytical skills.
• 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.

Salary and Benefits

We offer a competitive base salary, commensurate with experience. In addition to the salary, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, retirement plans, and stock option awards.

About the Role

NewAmsterdam is an innovative biotech company with the experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related diseases. Our vision is that people at risk for heart disease can take control of their health and live longer, fuller lives. Our team is led by a world-class team of industry veterans and key opinion leaders, including some of the world’s preeminent cardiometabolic experts and we foster a passionate, supportive culture that is backed by a high level of integrity and inclusivity.