Associate Director/Director, Chemical Development (Drug Substance CMC)

NewAmsterdam Pharma Corporation

22d

About The Position

Job Description: NewAmsterdam Pharma is seeking an experienced leader of Chemical Development (Drug Substance CMC) to provide technical leadership and hands‑on execution in support of late‑stage development, tech transfer, commercial readiness, and lifecycle management of small‑molecule APIs. The position may be filled at either the Associate Director or Director level based on the candidate’s experience and qualifications. Reporting to the Senior Director, Drug Substance, this role will play a critical part in API process and chemical development, managing external CDMOs, building redundancies to ensure reliable product supply, and contributing to global regulatory submissions and post‑approval change management. The team operates in a highly collaborative, results‑oriented, and fast-paced environment, requiring a hands-on mindset and strong cross-functional engagement.

Requirements

• Advanced degree (preferably a PhD) in Organic Chemistry, Chemical Engineering, or a relevant scientific discipline; Exceptional candidates with a bachelor’s degree and extensive experience may also be considered.
• 10+ years pharmaceutical and/or biotech CMC experience in small-molecule drug substance chemical development and manufacturing.
• Demonstrated experience leading technology transfer into GMP manufacturing sites and supporting late-stage development programs.
• Proven experience working with and managing CDMOs, including oversight of technical execution and documentation.
• Strong skills applying fundamental engineering and scientific principles to process design, implementation, tech transfer, and production.
• Strong understanding of DOE, PAR studies, control strategies (including impurity control), and ICH Q8/Q9/Q10/Q11 principles.
• Hands-on experience authoring relevant CMC sections for NDA/MAA filings, experience managing post-approval changes is highly desired.
• Strong written and verbal communication skills, with the ability to convey complex technical information at the appropriate level of detail to cross‑functional teams and senior leadership.
• Highly detail-oriented, data-driven, and exceptionally organized, with the ability to manage complex datasets, timelines, and documentation with precision.
• Strong business acumen and the ability to operate effectively in a matrixed, fast‑paced environment while adapting to shifting priorities and maintaining scientific rigor and accountability.
• Ability to manage multiple projects simultaneously with strong organization and prioritization skills.
• Demonstrated ability to influence and collaborate across functions to drive strategic alignment.
• Demonstrated ability to anticipate challenges, develop proactive solutions, and navigate ambiguity.
• Proficiency with Microsoft 365 and relevant technical systems/tools.
• Ability to travel domestically or internationally (up to 20%) as required to support business priorities.

Nice To Haves

• Commercial manufacturing and lifecycle management experience strongly preferred.
• Experience with process safety assessment and hazard evaluation in chemical development and manufacturing is strongly preferred.
• Remote position: Northeast U.S. preferred.

Responsibilities

• Provide technical leadership for late‑stage through commercial drug substance process development, including process characterization, validation, and lifecycle management.
• Lead end‑to‑end technology transfer of RSMs and drug substance processes to new manufacturing sites, including strategy development, execution, risk assessment, and resolution of technical issues.
• Lead and/or support DOE studies, PAR establishment, and control‑strategy development to enable PPQ readiness and robust validation and commercial production performance.
• Manage external production and provide technical oversight, including review and approval of manufacturing and release documentation, proactive troubleshooting, and deviation investigations, and on-site (as needed) manufacturing support.
• Support commercial supply continuity, cost‑of‑goods optimization, implementation of continuous‑improvement initiatives, and long-term lifecycle‑management activities.
• Proactively identify technical gaps and risks, and lead the development and implementation of mitigation strategies, including effective engagement of external partners.
• Integrate process data and manufacturing knowledge, including building and maintaining a process knowledge base, establishing manufacturing parameters and quality profiles across sites, performing trend analysis, and identifying improvement opportunities.
• Contribute to broader drug‑substance CMC activities, including RSM and API strategy, route scouting, IP‑relevant assessments, and supporting downstream development & manufacturing success.
• Maintain accountability for CMC program timelines, budget, resource allocation, and key deliverables.
• Serve as a key CMC contributor to regulatory submissions, responses, and post‑approval change management (e.g., variations, supplements, comparability packages).
• Partner cross‑functionally with Quality, Regulatory Affairs, Analytical, Drug Product and Supply Chain to ensure integrated, compliant, and efficient drug‑substance development and manufacturing strategies.
• Ensure compliance with applicable GMP requirements, internal quality systems, and evolving global regulatory expectations, including participation in quality events such as change controls, investigations, and audits.
• Monitor industry trends, emerging technologies, and evolving regulatory expectations to ensure drug‑substance practices remain competitive and compliant.

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.
• NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.
• At NewAmsterdam Pharma, we are working to change the landscape of lipid-lowering treatment. By advancing innovative therapies for cardiovascular disease (CVD) and other lipid-related conditions we hope to enable people with cardiovascular risk to take control of their health and live longer, fuller lives.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree