Senior Director, Process Development

Senior Director, Process Development

Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.

Why Choose Editas?

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 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 Senior Director, Process Development you will:

• Drive CMC strategy development, implementation, and refinement through strong collaboration with key stakeholders and external partners.
• Lead a team of engineers to define and drive the execution of Process Development strategy for in vivo medicines towards IND/CTA and clinical manufacturing.
• Lead development of novel in vivo delivery systems (e.g., LNP, tLNP, etc.) through combination of internal and external resources, ensuring seamless transition from Research to PD and into GMP manufacturing.
• Responsible for production of representative materials for analytical development and formulation development studies.
• Lead technology transfer and scale-up of in vivo manufacturing process(es) to external manufacturing facilities for pre-clinical and clinical manufacturing.
• Provide technical oversight of external gRNA, mRNA, critical raw materials and excipients (e.g., pDNA, targeting moieties), and drug delivery (e.g., LNP) process development activities 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 gRNA, mRNA, and drug delivery (e.g., LNP) process sciences to direct the establishment and continuous improvement of 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.
• Lead cross-functional projects/working teams, champion new ideas/business process improvements to advance company’s in vivo pipeline and technology platforms.
• Author and review of regulatory submissions, technical reports, SOPs and work instructions.
• Maintain abreast latest industry trends 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:

• Degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline with a Ph.D. and 10+ years of relevant experience OR B.S./M.S. with 15+ years in drug development.
• 5+ years of leadership experience providing guidance and mentorship to high-performing engineers or scientists.
• Strong technical expertise and hands-on experience in state-of-the-art 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 and LNP manufacturing techniques [e.g. in vitro transcription (IVT), purification via chromatography, various modes of LNP mixing, and tangential flow filtration (TFF)] and critical raw material, drug substance, and drug product characterization methods and specifications are highly desirable.
• Ability to develop CMC strategies that are phase-appropriate (i.e., phase 1 vs. phase 3 requirements) and grounded in principles of risk management.
• 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.
• 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 cross-functional collaborations with other internal departments as well as external CDMOs.
• An understanding of 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..