Manager, CMC Drug Substance

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the planning, coordination, and implementation of vaccine development initiatives from late-stage clinical development to regulatory submission and commercial supply.

• Aid in the selection and onboarding process of a new Drug Substance Site.

• Oversee the technology transfer of a Phase 3 vaccine manufacturing process to external Drug Substance manufacturing partners.

• Implement technology transfer strategies, project plans, governance frameworks, and risk management strategies.

• Direct process characterization, comparability assessments, scale-up/scale-down studies, and process validation tasks.

• Create and uphold the Drug Substance process control strategy, encompassing CPP identification, cIPC definition, and contributions to CPV strategy.

• Draft, review, and approve CMC technical documentation and content for regulatory submissions.

• Manage technical deliverables, timelines, risks, and interdepartmental dependencies.

• Ensure adherence to cGMP, regulatory standards, quality benchmarks, and organizational protocols.

• Participate in funding proposals, grant reporting, and strategic planning to enhance vaccine access and equity.

⛳️ Requirements

• Bachelor's degree in biochemistry, chemistry, biology, chemical engineering, or a related pharmaceutical discipline.

• At least 7+ years of experience in biopharmaceutical CMC, manufacturing, process development, and technology transfer.

• Background in biopharmaceutical manufacturing, MS&T, and/or process development settings.

• Practical experience with mammalian or viral cell culture, upstream and downstream processing, and purification processes.

• Proficient in chromatography, filtration/ultrafiltration, and viral clearance methods.

• Previous technology transfer experience, encompassing site-to-site, scale-up, or CDMO transfers.

• Familiarity with adenovirus-vectored vaccines or other viral vector platforms is highly preferred; relevant experience in complex biologics manufacturing will also be considered.

• Excellent analytical, problem-solving, organizational, communication, and interpersonal skills.

• Direct experience in cGMP-regulated environments, including investigations of non-conformance, root cause analysis, change control, and CAPA implementation.

• Working knowledge of ICH guidelines and global regulatory standards, including FDA, EMA, and MHRA.

• Experience in supporting late-stage development programs, regulatory submissions such as BLA/NDA, and commercial supply operations.

• Experience collaborating with external manufacturing partners.

• Dedication to health equity and enhancing immunization access in underserved communities.

• Subject to a criminal background check.

• Request for three professional references.

• Verification of educational credentials/degrees.

🏝️ Benefits

• Travel requirement of up to 25%.