Associate Director, LNP Process 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:

The in vivo Gene Editing and Critical Component Process Development team in the Technical Development (Tech Dev) Department is seeking a highly motivated and experienced technical and organizational leader in Lipid Nanoparticle (LNP) and Ribonucleoprotein (RNP) product development. The successful candidate will lead a high-performing team, coordinating with process and analytical experts within Tech Dev and cross-functionally in Research and Discovery, Technical Operations, Manufacturing, and Quality, to develop and steer process development strategies to advance Editas’ in vivo and ex vivo gene medicine portfolio. The individual will also be a key contributor to the overall program CMC strategy. This role requires strong technical expertise in LNP manufacturing process design and development as well as a passion to lead, mentor and influence people.

Characterizing Your Impact:

As the Associate Director, LNP Process Development you will:

• Lead and grow a team of engineers to define and drive the execution of Process Development strategy for LNP as drug delivery vehicle towards IND and clinical manufacturing
• Lead the design and build out of an internal LNP PD lab including lab space planning, new equipment procurement, installation and training
• Responsible for production of representative LNP materials for analytical development and formulation development studies
• Lead technology transfer of LNP manufacturing process to external manufacturing facilities for pre-clinical and clinical manufacturing, in collaboration with other Tech Dev teams as well as the Manufacturing and Quality teams at Editas
• Provide technical oversight of external LNP process development activity and pre-clinical and clinical manufacturing (e.g. review of SoW, study report, batch records, support of troubleshooting/deviation investigation, and onsite PIP).
• Act as the lead Subject Matter Expert for LNP process science to direct the establishment and continuous improvement of LNP platform manufacturing processes through well-coordinated external and internal development efforts
• Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, and promotions. Identify opportunities and provide the means for employees to pursue career growth.
• Lead cross-functional projects/working teams, champion new ideas/business process improvements to advance company’s LNP pipeline and technology platforms
• Support CMC strategy development, implementation, and refinement for pertinent programs through strong collaboration with key stakeholders and external partners
• Author and review of regulatory submissions, technical reports, SOPs and work instructions
• Maintain abreast latest industry trends for LNP process and product knowledge, work cross-functionally (e.g. with Research, Business Development and Legal) to evaluate novel manufacturing technologies and new business partners
• Lead the team to be responsible for RNP process development activities including Process Characterization to drive PPQ readiness, technical support of PPQ and clinical manufacturing and regulatory filing, as well as Process development and Tech transfer support for early-stage programs

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 8+ (Ph.D.), 10+ (M.S.), 12+ (B.S.) years of relevant experience in drug development
• Strong technical expertise and hands-on experience in state-of-the-art LNP 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 LNP manufacturing technique [e.g. T-mixing and tangential flow filtration (TFF)] is a must
• Ability to apply Quality-by-Design (QbD) principles to process development strategy planning and execution is required
• Advanced 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 LNP, mRNA, and pertinent raw material (e.g. lipids) characterization methods and specifications is highly desirable
• Exceptional leadership and interpersonal skills as well as excellent presentation and scientific/technical writing skills is a must
• Strong organizational skills, and ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment.
• Experience in leading a team of direct reports and providing guidance and mentorship to junior engineers or scientists.
• Experience in leading cross-functional collaborations with other internal departments as well as external CDMOs.
• Understanding of LNP related industry guidance’s (FDA, PDA, ICH and BPOG), knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle.

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.