Senior Executive Director of Chemistry, Manufacturing & Controls

About the role

The Senior Executive Director of Chemistry, Manufacturing & Controls (CMC) will lead the end‑to‑end development of a small‑molecule portfolio, from candidate selection through clinical trials, driving both drug substance and drug product strategies.

Key responsibilities

• Define and execute the global CMC strategy for the small‑molecule pipeline, ensuring smooth transition from lead optimization to IND/CTA enablement.
• Oversee drug substance development, including process chemistry optimization, route scouting, crystalline form screening, and scale‑up of critical APIs.
• Lead formulation and drug product design, managing pre‑formulation studies and advanced delivery technologies such as amorphous solid dispersions, nanomilling, and lipid‑based systems.
• Direct analytical and quality‑control strategies for both drug substance and drug product, covering impurity control, stability, and reference standards.
• Source, negotiate, and manage global CDMOs, monitoring performance, tech‑transfer milestones, and contractual obligations.
• Act as the primary technical authority for regulatory interactions, authoring CMC sections of INDs, IMPDs, CTAs and future NDAs.
• Collaborate cross‑functionally with medicinal chemistry, discovery biology, DMPK, and clinical operations to secure clinical trial material supply.

Required profile

• PhD (or MS) in Synthetic Organic Chemistry, Chemical Engineering, Analytical Chemistry or related field with at least 12 years (PhD) or 16 years (MS) of industrial CMC experience.
• Proven track record leading CMC programs, managing CDMOs, and authoring high‑quality regulatory filings.
• Strong communication, negotiation and executive presence to convey technical risk to senior leadership.

Required skills

• Synthetic organic chemistry and process chemistry optimization.
• Pre‑formulation characterization and advanced formulation development.
• Analytical method development, transfer, validation and QC testing.
• cGMP laboratory operations and ICH guideline expertise.
• CDMO contract negotiation, tech‑transfer oversight, and multi‑partner program management.

What we offer

• Competitive pay and stock option eligibility.
• 401(k) plan, open PTO policy and paid holidays.
• Free lunch and snacks at the office.
• Fully covered medical, dental, and vision health care for employees.