Associate Director, Lipid Process Chemistry

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.

Responsibilities

• 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.

Requirements

• Ph.D. in Organic Chemistry, Synthetic Chemistry, or a closely related discipline with a minimum of 6-7+ years of direct experience working within an established lipid synthesis and/or LNP therapeutic company or similar industry (e.g., mRNA therapeutics, oligonucleotides, gene therapy, or drug delivery biotech platforms).
• Or, BS/MS in Organic Chemistry, Synthetic Chemistry, or a closely related discipline with a minimum of 10-12+ years of direct experience working within an established lipid synthesis and/or LNP therapeutic company or similar industry (e.g., mRNA therapeutics, oligonucleotides, gene therapy, or drug delivery biotech platforms).
• Proven expertise in the multi-step organic synthesis, scalable purification, and analytical characterization (NMR, LC-MS, HPLC) of custom lipids or advanced small-molecule raw materials.
• Demonstrated success managing external CDMO partners through process optimization, tech transfer, and clinical supply production.
• Proven track record of successfully managing technical teams and partnering with cross-functional stakeholders to achieve organizational objectives.
• Deep understanding of current Good Manufacturing Practices (cGMP), ICH guidelines, and regulatory expectations for clinical-stage drug substances.

Preferred Qualifications

• Prior experience preparing for or participating in CMC health authority interactions or regulatory audits.
• Strong track record of taking a novel lipid from discovery candidate nomination through successful Phase I/II clinical trial GMP supply.
• Experience implementing Process Analytical Technology (PAT) tools or continuous flow chemistry for lipid manufacturing.
• Active presence and network in the Boston/Cambridge biotechnology ecosystem.