Sr. Director, Drug Substance Development and Manufacturing

NewAmsterdam Pharma B.V. (NAP) https://www.newamsterdampharma.com/ is a clinical-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. NewAmsterdam seeks to fill a significant unmet need for a safe, cost-effective, and convenient LDL-lowering therapy as an adjunct to the current standard of care for high-risk cardiovascular disease in patients with high cholesterol. NewAmsterdam is investigating a CETP inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally tolerated statin therapy.

We are seeking a senior leader for the Senior Director, Drug Substance Development and Manufacturing position. The Sr. Director is responsible for leading all aspects of the Drug Substance manufacturing including process development & improvement, manufacturing and commercial preparedness including building redundancies to ensure product supply. This position requires a strategic thinker with a thorough understanding of development, including late state and commercialization and requires a high level of collaboration both with internal teams and external partners. The Sr. Director reports to the Chief Manufacturing Officer.

Key Responsibilities:

• Oversee all aspects of drug substance process development and manufacture of our Contract Manufacturing Partners to ensure reliable, compliant, cost-effective, and on-time supply
• Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence
• Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression
• Manage relationships with contract manufacturing organizations and ensure they meet our quality and production requirements.
• Oversee technology transfer of drug substance processes to CMOs
• Develop and manage the DS budget, ensuring efficient use of resources and cost-effective processes
• Implement continuous improvement initiatives to enhance manufacturing efficiency, reduce costs, enable strategic redundancies, and improve product quality from both technical and strategic sourcing perspectives
• Prepare technical reports and presentations to communicate results and progress to internal and external stakeholders including leadership team
• Own the drug substance modules in the regulatory dossier and collaborate with regulatory affairs to support regulatory submissions and inspections
• Stay informed about industry trends, technological advancements, and regulatory changes to ensure our manufacturing processes are competitive and compliant

Qualifications:

• PhD in Chemistry, Chemical Engineering, or related life sciences field is desirable
• 12+ years of relevant experience in development and manufacturing for commercial scale, Process Characterization, Technical Transfer (to commercial sites), and Process Validation
• Experience in a small company or start-up environment is preferred
• Strong knowledge of cGMPs, Quality and regulatory systems, and/or guidance
• Strong skills applying fundamental engineering and scientific principles to process design, implementation, and tech transfer
• Experience managing and building strong relationships with contract manufacturing organizations
• Experience with successful drug submissions (IND, BLA, IMPD, MAA, etc.) as well as phase-appropriate cGMP requirements
• Ability to think critically with a keen sense of urgency, entrepreneurial spirit and demonstrated problem solving abilities
• Exceptional problem-solving and decision-making skills, with the ability to integrate complex scientific information into drug development plans
• Ability to ensure accountability of oneself and others
• Detail-oriented with exceptional ability to anticipate and mitigate risks/issues
• Project management skills, including the ability to manage multiple projects; assess inter-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
• Demonstrated ability to provide leadership to cross-functional teams to advance complex projects to completion
• Excellent verbal and written communication skills with an ability to build relationships internally and externally
• Excellent computer skills (e.g. Word, Excel, PowerPoint, Teams)
• Location: remote with occasional travel domestically or internationally (Boston MA area preferred)

Salary and Benefits:

We offer a competitive base salary range, 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.

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.