Senior Process Engineer I, Protein Process Development - 2407
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 and Gene Editing Components Process Development team in the Process and Analytical Development (PAD) Department is seeking a highly motivated and experienced Sr. Process Engineer for gene-editing product development from IND-enabling to commercial stages. The successful candidate will lead and execute downstream process development projects for critical gene-editing components, coordinating within PAD and cross-functionally in Discovery, Manufacturing, Supply Chain, and Quality, to advance Editas’ gene medicine portfolio. The individual will also be a key contributor to overall process development strategies.
- Lead or support study design and execution in downstream process development, scale-down model qualification and process characterization for protein products (e.g., CRIPSR nucleases) as critical gene-editing components
- Drive or assist in projects in downstream process scale-up, technical transfer to external manufacturing facilities and clinical and commercial manufacturing, in collaboration with Analytical, Manufacturing and Quality teams
- Act as a downstream SME for clinical and commercial manufacturing as well as process validation for protein products as part of a CMC team
- Support representative protein material generation for process characterization, analytical development (AD) and toxicology studies
- Collaborate with AD/QC to generate and interpret data for formulation studies, stability studies, and characterization of drug substance and/or drug product
- Document experimental work, supporting information and data in an electronic lab notebook (eLN) in a timely manner. Write SOP, work instructions and batch records and may contribute to regulatory document drafting and review
- Compile and present data and assist in authoring and reviewing batch records, work instructions, technical reports, and supporting procedures
- Cross-train personnel on downstream unit opts and pertinent in-process analytical methods, and provide guidance to junior team members, as required
- Maintain abreast latest industry trends for biologics manufacturing processes and product knowledge, work cross-functionally (e.g., with Discovery, Business Development and Legal) to evaluate novel manufacturing technologies and new business partners
- Contribute to equipment procurement, setup and training
- Other responsibilities as required.
Knowledge, Skills & Capabilities:
- Strong technical expertise and meaningful hands-on experience (i.e., independently design, execute and troubleshoot experiments) in biologics downstream process development and/or manufacturing in a drug development setting are required
- Proficiency in commonly used biologics purification techniques such as depth filtration, tangential flow filtration (TFF) and a variety of chromatography (IEX, HIC, Affinity, etc) are a must
- Solid ability and track record of implementing downstream scale-up and -down principles are required
- Knowledge and experience with Quality-by-Design (QbD) principles and risk assessment tools (e.g., FMEA) for process development and characterization are highly preferred
- Advanced skills in experimental design (e.g. DOE) and data analyses using relevant statistical software packages (e.g., JMP) for process development and characterization are highly preferred
- Prior experience supporting process technical transfer and late-stage regulatory filings as a process SME are preferred
- Strong organizational skills with the ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment are highly desirable
- Proficient verbal and written communication skills
- Basic understanding of common analytical tools utilized in testing and characterization of biologics (e.g., SEC, ELISA, qPCR/ddPCR, CE-SDS, mass spectrometry, etc) is a plus
- Familiarity with gene therapy/editing industry guidance and biologics drug development life cycle is a plus
Education & Relevant Work Experience:
- Degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline with 2+ (Ph.D.), 6+ (M.S.), 8+ (B.S.) years of relevant experience in drug development
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.