Vice President​/Senior Director, CMC & Technical Operations

Vice President / Senior Director, CMC & Technical Operations

About Contraline Inc.

Contraline is a clinical-stage biotechnology company focused on innovation in male reproductive health. The company is advancing both hormonal and non-hormonal approaches to expand contraceptive options for men and couples globally.

Following its recently completed Series B financing, Contraline is entering a pivotal stage of growth as it advances toward late-stage clinical development, regulatory milestones, expanded manufacturing, and future product launch.

About the role

Contraline is seeking an experienced leader to serve as the company's single accountable owner for pharmaceutical Chemistry, Manufacturing & Controls (CMC), responsible for defining strategy and driving execution from Phase 3 readiness through regulatory approval, commercial launch manufacturing, and lifecycle management support. Working closely with Quality, Regulatory Affairs, Clinical Development, Program Management, and external partners, this individual will ensure manufacturing, supply, and CMC activities support the company's development, regulatory, and commercial objectives.

The ideal candidate has directly led late-stage pharmaceutical CMC programs in a small or mid-size biotechnology company and combines strategic thinking with hands‑on execution. They are comfortable making sponsor-side technical decisions, building fit‑for‑purpose systems, leading through influence, managing external partners, and delivering high‑quality technical outcomes in a fast‑paced, resource‑conscious environment.

Key Responsibilities

• Own sponsor-side pharmaceutical CMC strategy and decision-making from Phase 3 through commercial launch, serving as the company's single accountable leader for manufacturing strategy, regulatory CMC, commercial readiness, and lifecycle management.
• Own sponsor-side technical decisions regarding manufacturing strategy, process changes, comparability, validation strategy, supply risk, and regulatory CMC, ensuring decisions appropriately balance technical, regulatory, timeline, and business considerations.
• Translate CMC gaps, risks, and regulatory expectations into practical execution plans with clear priorities, timelines, resources, owners, and decision points.
• Serve as a hands‑on CMC leader who personally advances critical work streams while coordinating cross‑functional execution across development, manufacturing, analytical, regulatory, quality, supply, and commercialization activities.
• Serve as Contraline’s internal owner for CMC regulatory strategy, including IND maintenance, health authority interactions, submission readiness, information requests, and future marketing application content.
• Prepare, review, and maintain clear, technically consistent CMC source documents and submission‑ready materials.
• Develop CMC strategies for key regulatory meetings and phase‑transition decisions, ensuring technical issues are appropriately addressed at the right stage of development.
• Own pharmaceutical manufacturing and control strategy across drug substance, drug product, analytical methods, stability, specifications, comparability, process understanding, and lifecycle management.
• Serve as the primary sponsor‑side technical and business lead for external manufacturers, laboratories, suppliers, logistics partners, and CMC consultants.
• Lead technology transfer, manufacturing campaign planning, process validation, supply planning, and commercial readiness while proactively identifying and mitigating manufacturing, quality, and supply risks.
• Build and execute a registration‑and‑launch‑enabling CMC roadmap covering validation strategy, commercial supply assumptions, stability commitments, inspection readiness, and post‑approval lifecycle management.
• Translate complex CMC issues into clear recommendations for executive leadership while maintaining strong sponsor accountability across external partners.
• Assess CMC aspects of Business Development assets or potential acquisitions as required.

Required Qualifications

• BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific discipline; advanced degree preferred but not…