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.

The company's owner for pharmaceutical Chemistry, Manufacturing & Controls (CMC), responsible for defining strategy and driving execution from Phase 3 readiness through regulatory approval and commercial launch manufacturing.

• 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 workstreams 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.

• BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific discipline; advanced degree preferred but not required with directly relevant experience.
• 15+ years of pharmaceutical or biotechnology industry experience in CMC, pharmaceutical development, technical operations, manufacturing, or related functions.
• Demonstrated experience serving as the sponsor-side CMC lead for a late-stage pharmaceutical development program, including ownership of CMC strategy, external manufacturing, and regulatory interactions.
• Hands-on experience writing, preparing, reviewing, or defending CMC content for regulatory submissions and health authority interactions, including INDs and/or marketing applications.
• Strong working knowledge of FDA CMC expectations, ICH guidelines, cGMP requirements, pharmaceutical manufacturing, analytical development, stability, specifications, and control strategy.
• Demonstrated success working with CDMOs, analytical laboratories, suppliers, consultants, or other external partners in a sponsor-led or virtual biotech operating model.
• Experience translating technical, regulatory, manufacturing, and quality issues into practical execution plans, risk-based recommendations, and clear decisions.
• Proven ability to lead cross-functionally across Regulatory, Quality, Clinical, Manufacturing, Supply Chain, Program Management, and executive stakeholders.
• Strong written and verbal communication skills, including the ability to prepare high-quality technical documents and communicate complex CMC issues clearly to non-CMC audiences.
• Highly organized, self-directed, and comfortable operating in a hands-on, fast-paced, resource-conscious company environment.

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