About this opportunity
Contraline, Inc. lists this Vice President / Senior Director, CMC & Technical Operations opportunity in charlottesville, Virginia. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Vice President / Senior Director, CMC & Technical Operations
About Contraline
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.
What you'll do
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.
What you'll need
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.
Contraline’s products are investigational and have not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.
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Worksite address
charlottesville, VA, 22904, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.