Executive Director, API Development, Small Molecule

For our client, we are seeking a Executive Director, API Development, Small Molecule to join the team of a leader in the Pharmaceuticals & Biotech space.

This leader will shape the strategy and execution for small molecule API development across a portfolio of programs, with a focus on advancing processes from early development through commercialization. The role partners closely with Technical Operations, regulatory stakeholders, and cross-functional teams to improve product quality, manufacturing readiness, and cost effectiveness. It also requires external-facing leadership through publications, presentations, and scientific collaborations.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $247,000 – $337,000 annually

Responsibilities

• Establish and execute the long-term vision and strategy for API Development aligned with corporate objectives.
• Lead API development initiatives including technology transfer and process validation across programs.
• Influence portfolio decisions and resource allocation as part of Technical Operations leadership.
• Direct design and scale-up of processes from laboratory to manufacturing.
• Manage development and implementation of process methods for improved product quality and cost-effectiveness.
• Oversee development of new process formulas and equipment specifications.
• Represent the company externally through publications, presentations, and collaborations.

Qualifications

• PhD in a relevant field with 10 years of CMC experience, or MS with 12 years, or BS with 15 years in the pharmaceutical industry.
• Extensive expertise in small molecule API route design, process development, and regulatory strategy.
• Strong commitment to experimental work with the ability to independently solve complex problems.
• Thorough understanding of cGxP, CMC, ICH, and compendial regulatory requirements.
• Experience authoring and reviewing CMC sections of regulatory submissions including INDs and NDAs.
• Proven track record managing multiple programs and staff through commercialization.
• Exceptional communication and negotiation skills for high-level interactions.

Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• Generous paid time off and family-forming benefits, including caregiver support.
• 401(k) plan with a competitive company match and equity awards.
• Access to a learning institute for workshops, mentorships, and networking.
• Employee resource groups and community service opportunities.

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.