Sr. Director/Director, CMC Lead
REMOTE
Position Summary
We are partnered with a leading Clinical Stage Biotech that is seeking an experienced Sr. Director/Director, CMC Lead to provide strategic and operational leadership for all Chemistry, Manufacturing & Controls (CMC) activities across one or more small molecule development programs.
The successful candidate will serve as the primary CMC representative on cross-functional development teams and will be responsible for establishing and executing CMC strategy from preclinical through late-stage clinical development and commercialization. This individual will oversee external CDMO relationships, ensure alignment across Drug Substance, Drug Product, Analytical Development, Quality, Regulatory Affairs, and Supply Chain, and drive delivery of key program milestones.
This is a highly visible role requiring strong technical expertise, leadership skills, and the ability to influence cross-functional stakeholders in a fast-paced biotech environment.
Key Responsibilities
CMC Strategy & Program Leadership
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Develop and execute integrated CMC strategies supporting clinical and commercial development objectives.
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Serve as the CMC representative on program teams and provide technical leadership across all CMC disciplines.
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Lead CMC planning, risk assessments, timelines, budgets, and milestone execution.
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Identify and mitigate technical, manufacturing, regulatory, and supply chain risks.
Drug Substance & Drug Product Oversight
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Oversee small molecule API development, process optimization, scale-up, technology transfer, and manufacturing.
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Provide strategic oversight of formulation development, process development, and commercial readiness activities.
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Ensure phase-appropriate control strategies are established and maintained.
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Support lifecycle management and commercial manufacturing strategies.
Partner Management
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Partner with functional leads of Process Chemistry, Analytical Development, and Formulation to ensure all technical workstreams are progressing according to plan, with clear deliverables and interdependencies.
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Lead selection, qualification, and oversight of CDMOs, CROs, analytical laboratories, and other external partners.
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Manage technical interactions and governance with external manufacturing organizations.
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Monitor project execution, timelines, budgets, and deliverables.
Regulatory CMC
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Author, review, and approve CMC sections of regulatory submissions including: INDs, IMPDs, NDAs and BLAs
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Support agency interactions and regulatory inspections as needed.
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Ensure compliance with FDA, EMA, and ICH requirements.
Budget & Resource Management
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Develop and manage CMC budgets.
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Maintain forecasting and resource planning across development programs.
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Evaluate outsourcing strategies and vendor performance.
Education, Experience & Qualifications
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Ph. D or MS. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
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12+ years of progressive experience within the pharmaceutical or biotechnology industry, including leadership responsibilities across multiple CMC functions.
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Demonstrated success leading cross-functional CMC teams supporting small molecule development programs from IND-enabling activities through late-stage development and commercial readiness.
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Strong understanding of Drug Substance, Drug Product, Analytical Development, Manufacturing, Quality, and Regulatory CMC requirements.
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Extensive experience interacting with CDMOs, and external development and manufacturing partners.
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Thorough knowledge of FDA, EMA, ICH, and global regulatory requirements governing pharmaceutical development and commercialization.
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Proven track record supporting successful IND, NDA, and other global regulatory submissions.
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Exceptional leadership, communication, organizational, and stakeholder management skills.
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Ability to operate effectively within a fast-paced, highly collaborative, outsourced biotech environment.
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Experience balancing strategic leadership with hands-on execution in a lean and rapidly evolving organization.
