Process Engineer, Formulation Development

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:

As a Process Engineer, you’ll be a vital contributor to our mission and our success. The in vivo Gene Editing and Critical Components Process Development team in the Technical Development Department is seeking a highly motivated Process Engineer for the process and formulation development of critical gene editing components and drug products [e.g. Ribonucleoprotein (RNP), messenger RNA (mRNA) & Lipid Nanoparticle (LNP)]. The successful candidate will support the design and execution of pertinent process and formulation development projects, coordinating with process and analytical experts within Technical Development and cross-functionally in Research and Discovery, Technical Operations, Manufacturing, and Quality, to advance Editas’ ex vivo and in vivo gene editing programs. 

Characterizing Your Impact:

As the Process Engineer, you will:

• Lead or support experiments for RNP, mRNA/LNP manufacturing process definition, scale-down model qualification, process characterization/optimization and scale-up to meet clinical and commercial material demand 
• Support the generation of representative materials for analytical method development and toxicology studies 
• Support technology transfer of mRNA/LNP manufacturing process to internal or external manufacturing facilities for clinical and commercial manufacturing, in collaboration with Manufacturing and Quality teams 
• Collaborate with AD to generate data for formulation studies, stability studies, and characterization of drug substance and/or drug product  
• Provide technical support for engineering and cGMP manufacturing campaigns (e.g. batch record review, change control management, deviation investigation, etc) in collaboration with other line functions (e.g., Manufacturing Sciences & Technology), as needed 
• Document all experimental work, supporting information, and data in an electronic lab notebook (eLN) in a timely manner 
• Compile and present data, and assist in authoring and reviewing of batch records, work instructions, protocols, plans, technical reports, SOPs, and may contribute to regulatory document drafting and review 
• Cross-train personnel on processes, and provide guidance to junior team members, as required 
• Maintain abreast latest industry trends for RNP, LNP and nucleic acid-based process and product knowledge 
• Contribute to equipment procurement, setup and training  
• Other responsibilities as required. 

Requirements

The Ideal Transcript:

To thrive in this role, you’ll need:

• Bachelor’s experience in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline with 6+ years of relevant experience or Master’s with 4+ years of experience. 
• Strong technical expertise and meaningful hands-on experience in mRNA/LNP formulation development, scale-up and/or manufacturing in a drug development setting are required. 
• Proficient UFDF/Dialysis operation skills with solid understanding of scale-up principles.
• Proficient verbal communication and technical writing skills.  

Fundamentals That Set You Apart

• Solid knowledge and experience with QbD and common risk assessment tools for process development and characterization are highly preferred. 
• Working knowledge of general downstream purification techniques (e.g. depth filtration, Chromatography) is a plus. 
• Experience in molecular biology and microbial manufacturing of nucleic acids or protein are preferred. 
• Experience in Technical Transfer of cGMP manufacturing processes and regulatory filing support for biologics. 
• Working knowledge of mRNA, LNP and pertinent raw material (e.g. lipids) characterization methods and specifications is highly preferred. 
• Strong organizational skills with the ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment. 

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.