Senior Process Engineer I, LNP Process Development - 2335 in Cambridge, Massachusetts
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) 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 many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
The in vivo Process Development team in the Process and Analytical Development (PAD) Department is seeking a highly motivated and experienced Sr. Process Engineer for messenger RNA (mRNA) & Lipid Nanoparticle (LNP) product development. The successful candidate will lead and execute LNP process development projects, coordinating with process and analytical experts within PAD and cross-functionally in Research and Discovery, Technical Operations, Manufacturing, and Quality, to advance Editas’ in vivo gene medicine portfolio utilizing nanoparticle technology. This role offers abundant growth opportunities in an innovative, science-driven, and multimodality organization.
Design and execute strategies and experiments for LNP manufacturing process definition, scale-down model qualification, process characterization/optimization and scale-up to meet clinical and commercial material demand
Lead the generation of representative LNP 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
Support mRNA/LNP engineering and cGMP campaigns by conducting technical review of batch records, risk assessment, change control management and deviation investigation, working in concert with other CMC line functions
Act as Subject Matter Expert for mRNA and LNP process science to establish and continuously improve company’s LNP platform manufacturing processes through well-coordinated internal and external development efforts
Supervise and manage Contract Development and Manufacturing Organization (CDMO) for external collaborations as needed
Participate in portfolio and stage-gate reviews, CMC strategy development and implementation as part of cross-functional working teams
Present project data and progress at individual, group, departmental meetings, and scientific conferences
Author Electronic lab notebook (ELN) records, technical reports, process descriptions, SOPs, work instructions, and assist in preparation of regulatory submissions
Conduct technical training for team members and provide professional development support as needed
Contribute to resource planning, lead instrument procurement, installation, and training
Maintain abreast latest industry trends for LNP and nucleic acid-based process and product knowledge, assist in cross-functionally (e.g. with Research, Business Development and Legal) diligence efforts to evaluate novel manufacturing technologies and new business partners as needed
Other duties as assigned
Maintain a high level of productivity in the laboratory setting and adhere to lab safety regulations and best practices
Knowledge, Skills & Capabilities:
Strong technical expertise and hands-on experience in state-of-the-art mRNA and LNP manufacturing process sciences as demonstrated through publication records, patent filings or meaningful work in a drug development setting are required
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 required
Excellent critical thinking and problem solving, scientific/technical oral and writing skills are required
Ability to apply Quality-by-Design (QbD) principles to LNP formulation and process optimization experiments is highly desirable
Experience in molecular biology and microbial manufacturing of nucleic acids or protein are preferred
Working knowledge of mRNA, LNP and pertinent raw material (e.g. lipids) characterization methods and specifications is preferred
Experience in leading collaborations with CDMOs is a plus
Understanding of mRNA/LNP related industry guidance’s (FDA, PDA, ICH and BPOG), knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle
Education & Relevant Work Experience:
- Degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline with 1+ (Ph.D.), 6+ (M.S.), 8+ (B.S.) years of relevant experience in drug development
Physical & Travel Requirements:
• Travel to support technical transfer efforts, as required.
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.