About the Team: Our group, as part of the Targeted Lipid Nanoparticle (tLNP) CMC team (TCT), collaborates across biologics discovery, CMC partners, Clinical Operations, Regulatory Affairs, Quality Assurance, and external manufacturing to advance tLNP assets from preclinical stages through key clinical milestones. Our priorities include establishing robust production processes in mammalian and microbial systems with our external partners, overseeing technology transfer and vendor management, reviewing critical technical documentation, and ensuring compliance with ICH guidelines and GMP standards. Through strategic management of external projects and the application of scientific innovation to process execution, we proactively mitigate risks and consistently deliver high-quality drug product components in support of the company’s tLNP pipeline and commercial goals.

Purpose: We are seeking an experienced scientific professional to lead the management of external projects with vendors, primarily in DNA plasmid production in microbial systems. The successful candidate will have a strong background in upstream culture or downstream purification process development, and will demonstrate proven project management skills, ideally with experience performing tech transfers between vendors and managing external vendors.

Responsibilities: 

• Serve as the lead and provide support for one or more plasmid production Chemistry, Manufacturing, and Controls (CMC) projects, guiding cross-functional teams from planning through execution in a matrix environment.
• Manage external vendor project execution to ensure quality, efficiency, timeliness, and adherence to budget and company objectives.
• Review and assess technical documents such as master batch records, executed batch records, and related GMP documentation to ensure compliance, accuracy, and alignment with regulatory standards and project objectives
• Apply scientific expertise to supervise and troubleshoot upstream and/or downstream processes in DNA plasmid production.
• Proactively identify project risks and challenges, proposing innovative solutions and strategies.
• Coordinate and facilitate communication among internal stakeholders and external partners/vendors.
• Utilize strategic thinking and process development experience to optimize project outcomes.
• The position may require occasional travel to vendor sites or conferences, depending on project needs.