Vice President – CMC & Technical Operations

Contraline

Vice President/Senior Director for CMC overseeing strategy and execution at biotechnology company. Leading efforts from Phase 3 through regulatory approval and commercial launch.

Posted 7/7/2026full-timeRemote • Virginia • 🇺🇸 United StatesSenior💰 $200,000 - $275,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

CMC Document PreparationManufacturing StrategyProcess ValidationAnalytical DevelopmentSupply PlanningRisk AssessmentLifecycle ManagementPhase Transition DecisionsTechnical OperationsPharmaceutical Development

Soft Skills

Decision-MakingCollaborationCommunicationLeadershipProblem-Solving