Lead Lipid Process Chemistry – GMP & CDMO Collaboration

Editas Medicine; Town of Cambridge; Remote; AUD 265,000 - 287,000; Full time

Benefits offered by this job

Blue Cross Blue Shield PPO Medical

Health Savings Account

Dental and Vision Insurance

Life and Disability Insurance

Dependent Care Account

Tuition Reimbursement

401(k) with company match

Employee Assistance Plan

Wellness Programs

Flexible PTO

Job summary

Editas Medicine seeks an Associate Director of Lipid Process Chemistry to lead GMP manufacturing scale-up of novel lipid components for our LNP therapeutic pipeline. You will act as the primary CMC liaison with CDMOs, drive tech transfer, and ensure regulatory-compliant production, partnering with R&D, Analytical, and Quality teams.

The role requires a Ph.D. in Organic Chemistry with 6–7+ years in lipid synthesis/LNP or a BS/MS with 10–12+ years, plus a proven track record in cross-functional

Qualifications

• Ph.D. in Organic Chemistry or closely related field with 6–7+ years in lipid synthesis/LNP or similar
• BS/MS in Organic Chemistry with 10–12+ years in lipid synthesis/LNP or similar
• Proven multi-step organic synthesis, scalable purification, and analytical characterization of lipids or lipid-like materials
• Experience managing external CDMO partners through tech transfer and clinical supply production
• Strong track record leading technical teams and cross-functional collaboration
• Deep knowledge of cGMP, ICH, and regulatory expectations for clinical-stage drug substances

Responsibilities

• Serve as technical lead and primary CMC contact for CDMOs
• Provide oversight of outsourced manufacturing campaigns and change controls
• Act as PIP during critical manufacturing runs at CDMOs
• Identify scale-up risks and drive root-cause investigations
• Direct external partners in route scouting and scale-up
• Collaborate with R&D to design and source novel lipid constructs
• Develop scalable lipid isolation and purification processes
• Apply DoE/QbD to define critical process parameters
• Prepare transfer packages from R&D to cGMP manufacturing
• Draft lipid excipient regulatory documentation for submissions
• Coordinate with Formulation, Analytical Development, Quality, Manufacturing and Supply Chain

Skills

lipid synthesis

LNP expertise

CDMO management

regulatory knowledge

cross-functional leadership

Education

Ph.D. in Organic Chemistry

10+ years lipid synthesis/LNP experience

Tools

NMR

LC-MS

HPLC

DoE

QbD

Job description

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.

The Ideal Transcript:

To thrive in this role, you’ll need:

• 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.

Ideally, you would also have:

• 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.

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

Salary Range:

$185,000 - $200,000

Pay Transparency

Editas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.

Aspire to be an Editor? We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.