Senior Lipid Process Chemistry Lead – GMP & CDMO Engagement

Editas Medicine; Cambridge (MA); On-site; USD 185,000 - 200,000; Full time

Benefits offered by this job

Health insurance

Dental and Vision Insurance

401(k) plan with company match

Tuition Reimbursement

Employee Assistance Plan

Wellness Programs

Paid Time Off

Job summary

Editas Medicine in Cambridge, MA seeks an Associate Director of Lipid Process Chemistry to lead GMP lipid excipient development and scale-up within the Lipid Process Chemistry group. You will drive CDMO partnerships, oversee CMC activities, and ensure compliant transfer from R&D to manufacturing for the lipid components powering our pipeline.

Required: PhD with extensive lipid synthesis experience or a BS/MS with senior-level expertise, plus strong regulatory and cross-functional collaboration

Qualifications

• Ph.D. with 6–7+ years in lipid synthesis or LNP therapeutics preferred.
• Alternative: BS/MS with 10–12+ years in lipid synthesis/LNP fields.
• Proven external CDMO management and tech transfer experience.
• Strong understanding of regulatory expectations for clinical substances.

Responsibilities

• Serve as technical lead and CMC contact for CDMOs on lipid development and GMP manufacture.
• Provide oversight of manufacturing campaigns, including protocols and batch records.
• Act as PIP during critical runs at CDMO facilities.
• Identify risks and lead investigations for deviations and OOS results.
• Direct external partners in route scouting and scale-up for lipid production.
• Collaborate with Research to advance lipid constructs for delivery strategies.
• Develop scalable lipid isolation and purification processes.
• Apply DoE and QbD to set process parameters and controls.
• Author technology transfer packages to move from R&D to cGMP.
• Review lipid excipients for regulatory submissions (INDs/IMPDs/CTAs).
• Coordinate with QA, Manufacturing, and Supply Chain for integration.

Skills

Organic synthesis

Purification

Analytical characterization

NMR LC-MS HPLC

CDMO management

Team leadership

cGMP & ICH

Regulatory experience

Lipid synthesis

Phase I/II GMP supply

Education

Ph.D. in Organic Chemistry/Synthetic Chemistry

BS/MS in Organic Chemistry/Synthetic Chemistry

Tools

NMR

LC-MS

HPLC

Job description

Editas Medicine in Cambridge, MA seeks an Associate Director of Lipid Process Chemistry to lead GMP lipid excipient development and scale-up within the Lipid Process Chemistry group. You will drive CDMO partnerships, oversee CMC activities, and ensure compliant transfer from R&D to manufacturing for the lipid components powering our pipeline.

Required: PhD with extensive lipid synthesis experience or a BS/MS with senior-level expertise, plus strong regulatory and cross-functional collaboration