Process Engineer, Formulation Development
Editas Medicine
At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Position Summary
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.
Key Responsibilities:
As the Process Engineer, you will be responsible for:
- 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.