Associate Director, Lipid Process Chemistry

At Editas Medicine, we are pioneering the possible. Our mission and commitment are to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.

Why Choose Editas?

At Editas Medicine, we're a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what's possible in medicine, come join us and become an Editor!

Decoding The Role:

The Process Development team is seeking an experienced Associate Director of Lipid Process Chemistry to lead the development, scale-up, and technical oversight of GMP manufacturing of novel lipid components powering our lipid nanoparticle (LNP) therapeutic pipeline. This critical role requires a deep technical background in organic synthesis, purification, and analytics, blended with seasoned experience partnering with external Contract Development and Manufacturing Organizations (CDMOs).

The ideal candidate has a proven track record working directly within the LNP therapeutics or similar genetic medicine/advanced therapeutics industries. Operating within the Process Development department, you will serve as the primary Chemistry, Manufacturing, and Controls (CMC) lead for outsourced lipid excipient development and manufacture, guiding the transition from bench-scale chemical routes into robust, validated, and regulatory-compliant GMP production processes.

Characterizing Your Impact:

As the Associate Director of Lipid Process Chemistry, your responsibilities will be:

• Serve as the technical lead and primary CMC contact for CDMO partners supporting the development, scale-up, and GMP manufacture of novel lipids, including ionizable, helper, and PEGylated lipids.
• Provide technical oversight of outsourced manufacturing campaigns, including review and approval of protocols, master and executed batch records, deviations, and change controls.
• Act as Person-in-Plant (PIP) during critical engineering and clinical manufacturing runs at CDMO facilities.
• Identify process and scale-up risks and lead troubleshooting and root-cause investigations for manufacturing deviations and OOS results.
• Direct external partners in route scouting, process optimization, and scale-up to enable safe, efficient, and cost-effective lipid production.
• Partner with Research to drive the discovery, design, and sourcing of novel lipid constructs supporting pipeline programs and targeted delivery strategies.
• Develop scalable lipid isolation and purification processes using chromatography, crystallization, TFF, and related technologies.
• Apply DoE and QbD principles to define critical process parameters, material specifications, and process controls.
• Author and execute technology transfer packages to transition processes from R&D to cGMP manufacturing.
• Author and review lipid excipients for regulatory submissions, including INDs, IMPDs, and CTAs.
• Collaborate closely with Formulation, Analytical Development, Quality, Manufacturing, and Supply Chain teams to ensure successful integration of lipid raw materials into drug product manufacturing.
• Define and assess critical quality attributes (CQAs) and drive analytical and process strategies that support product quality, safety, and efficacy.