Associate Director, LNP Process Development
Editas Medicine
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