Vice President – CMC & Technical Operations

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🔥 55 minutes ago

⚔️ Virginia – Remote

⚔️ Virginia – Remote

💵 $200k - $275k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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Contraline

WebsiteLinkedInAll Job Openings

11 - 50 employees

⚕️ Healthcare Insurance

🌍 Social Impact

🤝 Non-profit

Healthcare Insurance • Social Impact • Non-profit

Contraline is a company deeply involved in providing comprehensive mental health and substance misuse services. With a focus on both adults and children, Contraline offers a wide array of therapeutic services from individual, couples, to group therapy sessions. They also emphasize community support and assertive community treatment while addressing psychiatric evaluations and medication management needs. Their services extend uniquely to the deaf and hard of hearing community, homeless outreach programs, and specialized treatment for individuals experiencing early psychosis. Contraline integrates these efforts with physical health care services to ensure holistic support. Its mission includes striking down stigma, sharing transformative stories, and encouraging community engagement in mental health conversations.

📋 Description

• Own sponsor-side pharmaceutical CMC strategy and decision-making from Phase 3 through commercial launch • Serve as the company's single accountable leader for manufacturing strategy, regulatory CMC, commercial readiness, and lifecycle management • Translate CMC gaps, risks, and regulatory expectations into practical execution plans with clear priorities, timelines, resources, owners, and decision points • 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 • Lead technology transfer, manufacturing campaign planning, process validation, supply planning, and commercial readiness • Assess CMC aspects of Business Development assets or potential acquisitions as required

🎯 Requirements

• BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific discipline • 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 • Hands-on experience writing, preparing, reviewing, or defending CMC content for regulatory submissions and health authority interactions • 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 • Proven ability to lead cross-functionally across Regulatory, Quality, Clinical, Manufacturing, Supply Chain, Program Management, and executive stakeholders

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development opportunities