Executive Director, API Development, Small Molecule

About the role

For our client, we are seeking an 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.

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.

Pay

$247,000 – $337,000 annually