Reports to: Senior Manager, CMC
Location: Remote work, US Only
Position Summary: The Manager, CMC Drug Substance provides technical leadership and expertise across Chemistry, Manufacturing, and Controls (CMC) activities supporting vaccine drug substance development. This role focuses on process development, characterization, technology transfer, and GMP manufacturing, supporting programs from late-stage clinical development through process validation, regulatory licensure, and commercialization.
The successful candidate will possess demonstrated experience leading technology transfers across process development and manufacturing environments, with hands-on knowledge of vaccine manufacturing operations and viral vaccine platforms, including adenovirus-vectored vaccines or comparable systems. The individual will provide technical leadership for drug substance development and manufacturing activities, partnering closely with internal teams, contract development and manufacturing organizations (CDMOs), and external stakeholders to support process scale-up, validation, regulatory compliance, and commercial readiness. Success in this role requires strong cross-functional collaboration, sound scientific judgment, and a commitment to advancing vaccine access and global health impact.
Working closely with internal teams, contract development and manufacturing organizations (CDMOs), and external stakeholders, the Manager will drive project execution by coordinating technical activities, managing risks, and ensuring alignment with program objectives, timelines, and regulatory requirements. The role requires strong scientific and technical expertise, sound judgment, and the ability to work effectively across cross-functional teams.
The Manager, CMC Drug Substance will collaborate across CMC, clinical, regulatory, quality, and global health functions to advance vaccine programs through critical development milestones. The ideal candidate combines technical leadership, intellectual curiosity, and a commitment to expanding equitable access to vaccines and improving global health outcomes.
Key Responsibilities: - Support the planning, coordination, and execution of vaccine development programs from late-stage clinical development through regulatory submission and commercial supply, partnering with cross-functional scientific, analytical, regulatory, manufacturing, and global health stakeholders to achieve key milestones and timelines
- Support site selection and onboarding of a new Drug Substance Site
- Lead the tech transfer of a Phase 3 vaccine manufacturing process to external Drug Substance manufacturing partners, ensuring successful process scale-up, validation, and commercial readiness
- Execute technology transfer strategies, project plans, governance structures, and risk mitigation plans to ensure successful transfer and lifecycle management of manufacturing processes
- Lead process characterization, comparability assessments, scale-up/scale-down studies, and process validation activities to establish robust manufacturing processes and support regulatory submissions. Develop and maintain the Drug Substance process control strategy, including process parameter criticality assessments, critical process parameter (CPP) identification, critical in-process controls (cIPCs), and contribute to continued process verification (CPV) strategies
- Author, review, and approve CMC technical documentation, including technology transfer packages, process characterization reports, validation documentation, regulatory submission content, comparability reports, and responses to Health Authority inquiries.
- Drive project execution by managing technical deliverables, timelines, risks, and cross-functional dependencies, ensuring alignment with organizational priorities, regulatory requirements, and donor commitments.
- Ensure compliance with cGMP, regulatory expectations, quality standards, and organizational procedures throughout process development, technology transfer, validation, and commercial manufacturing
- Contribute to funding proposals, grant reporting, and strategic planning efforts to advance vaccine access and equity worldwide
Requirements
- Bachelor's degree in biochemistry, chemistry, biology, chemical engineering or related pharmaceutical science
- Minimum of 7+ years of experience in biopharmaceutical CMC, manufacturing, process development, and technology transfer
- Demonstrated experience in biopharmaceutical manufacturing, MS&T, and/or process development environments, including hands-on experience with mammalian or viral cell culture, upstream and downstream processing, and purification operations (e.g., chromatography, filtration/ultrafiltration, viral clearance)
- Prior technology transfer experience, including leading or supporting site-to-site, scale-up, or CDMO transfers
- Experience with adenovirus-vectored vaccines or other viral vector platforms (e.g., AAV, poxvirus, lentiviral vectors) is strongly preferred; candidates with comparable complex biologics manufacturing experience will also be considered
- Strong analytical, problem-solving, organizational, communication, and interpersonal skills, with the ability to work effectively both independently and collaboratively across cross-functional teams, global stakeholders, and diverse audiences
- Commitment to health equity and improving immunization access in underserved populations
Preferred Skills and Experience:- Direct experience operating in cGMP-regulated environments, including support for non-conformance investigations, root cause analysis, change control, and CAPA implementation
- Working knowledge of ICH guidelines and global regulatory requirements (e.g., FDA, EMA, MHRA), with experience supporting late-stage development programs, regulatory submissions (e.g., BLA/NDA), and commercial supply activities
- Experience working with external manufacturing partners
Other: - Subject to a criminal background investigation
- Request for three professional references
- Verification of education/degrees
- Travel up to 25%
Salary Description
$109,000 - $130,000
