At Editas Medicine, we are pioneering the possible. Our mission and commitment is 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 courageous 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 in vivo Gene Editing and Critical Component Process Development team in the Technical Development Department is seeking a highly motivated and experienced technical leader in messenger RNA (mRNA) product development. The successful candidate will help drive mRNA process development effort, working with external and internal stakeholders, to advance Editas’ in vivo gene medicine portfolio utilizing nanoparticle technology. The individual will also contribute to the overall program CMC strategy. This role requires strong technical expertise in mRNA manufacturing process design and development as well as a passion to educate and collaborate with others.

Characterizing Your Impact:

As the Manager, mRNA Process Development you will:

• Drive the execution of Process Development (PD) strategy for mRNA drug substance for multiple LNP-based gene editing programs towards IND and clinical manufacturing

• Leveraging external resources, act as a Subject Matter Expert for mRNA process science to support mRNA manufacturing process definition, scale-up, and continuous improvement to meet clinical manufacturing demand

• Lead/support technology transfer (TT) of mRNA manufacturing process to external manufacturing facilities for clinical manufacturing, in collaboration with other Technical Development teams as well as Technical Operations and Quality teams

• Provide technical and operational oversight of external production of representative mRNA materials at Contract Research Organizations (CRO)/Contract Development and Manufacturing Organizations (CDMO) to enable analytical method development, formulation development and toxicology studies

• Build and maintain good working relationships with internal and external stakeholders e.g. Research, Development, Quality, suppliers, CDMOs, etc

• Support CMC strategy development, implementation, and refinement for pertinent programs through strong collaboration with key stakeholders and external partners

• Independently analyze data from PD and TT projects, present results and conclusions to the team

• Train peers/junior staff members on mRNA process and product knowledge

• Author and review of technical reports, SOPs, work instructions and regulatory submissions as needed

• Maintain abreast latest industry trends for nucleic acid-based manufacturing process and product knowledge, work cross-functionally (e.g. with Research, Business Development and Legal) to evaluate novel manufacturing technologies and new business partners

Requirements

The Ideal Transcript:

To thrive in this role, you’ll need:

Qualifications

• Degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline with 3+ (Ph.D.), 6+ (M.S.), 8+ (B.S.) years of relevant experience in drug development

• Strong technical expertise and direct experience in state-of-the-art mRNA manufacturing process development, optimization and scale-up as demonstrated through publication records, patent filings or meaningful work in a drug development setting are required

• In-depth expertise in mRNA manufacturing techniques [e.g. In vitro transcription (IVT), various modes of purification chromatography (e.g. oligo dT affinity, anion exchange, multimodal), tangential flow filtration, etc) is a must

• Substantial experience demonstrating productive collaborations with external CRO/CDMO is required

• Ability to apply Quality-by-Design (QbD) principles to process development strategy planning and execution is a plus

• Basic skills in experimental design (e.g. DOE) and data analyses using relevant statistical software packages (e.g. JMP) for process development, process characterization or formulation screening are highly preferred

• Working knowledge of mRNA and pertinent raw material characterization methods and specifications is highly desirable

• Exceptional interpersonal skills and excellent presentation and scientific/technical writing skills

Benefits

Benefits Summary:

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 Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

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.