Vice President / Senior Director, CMC & Technical Operations

About the role

Contraline Inc., a clinical‑stage biotechnology company focused on male reproductive health, is seeking a senior leader to own the company’s pharmaceutical Chemistry, Manufacturing & Controls (CMC) strategy from Phase 3 through commercial launch and lifecycle management. The role reports to senior leadership and works closely with Quality, Regulatory Affairs, Clinical Development and external partners to ensure CMC activities align with development, regulatory and commercial goals.

Key responsibilities

• Define and execute sponsor‑side CMC strategy and decision‑making from Phase 3 to market launch.
• Lead technical decisions on manufacturing strategy, process changes, comparability, validation, supply risk and regulatory CMC.
• Translate CMC gaps, risks and regulatory expectations into actionable plans with clear priorities, timelines and owners.
• Act as hands‑on CMC leader, advancing critical workstreams while coordinating cross‑functional teams across development, manufacturing, analytical, quality, supply and commercialization.
• Own CMC regulatory strategy, including IND maintenance, health‑authority interactions, submission readiness and marketing‑application content.
• Prepare, review and maintain consistent CMC source documents and submission‑ready materials.
• Develop CMC strategies for key regulatory meetings and phase‑transition decisions.

Required profile

• Proven experience leading late‑stage pharmaceutical CMC programs in a small or mid‑size biotech company.
• Strategic thinker with a hands‑on execution mindset in a fast‑paced, resource‑conscious environment.
• Ability to make sponsor‑side technical decisions, build fit‑for‑purpose systems and lead through influence.
• Strong track record managing external partners and delivering high‑quality technical outcomes.

Required skills

• Pharmaceutical Chemistry, Manufacturing & Controls (CMC).
• Manufacturing strategy and process validation.
• Regulatory affairs, IND maintenance and health‑authority interactions.
• Supply risk assessment and comparability studies.