Process Engineer, Process Development - 2377
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 Gene Editing and Critical Component Process Development team in the Process and Analytical Development (PAD) Department is seeking a highly motivated and experienced Process Engineer for the development of critical gene editing components [e.g. CRISPR-Cas nucleases, Ribonucleoprotein (RNP), etc]. The successful candidate will support the design and execution of process development projects, coordinating with process and analytical experts within PAD and cross-functionally in Technical Operations, Manufacturing, Quality, Research and Discovery to advance Editas’ ex vivo and in vivo gene editing program. This is a new position created to expand the team’s technical capability in late-stage drug substance development.
Key Responsibilities & Accountabilities:
- Lead or support experiments in process optimization, scale-down model qualification and process characterization for protein and RNP products
- Support representative protein and RNP material generation for process development and analytical development (AD)
- Collaborate with AD to generate data for formulation studies, stability studies, and characterization of drug substance and/or drug product
- Provide technical support for Process Tech Transfer, engineering and cGMP manufacturing campaigns (e.g. batch record review, change control management, deviation investigation, etc) in collaboration with other CMC line functions as needed
- Document all 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 of batch records, work instructions, technical reports, and supporting procedures.
- Cross-train personnel on processes, and provide guidance to junior team members, as required
- Maintain abreast latest industry trends for microbial protein manufacturing processes and product knowledge
- Contribute to equipment procurement, setup and training
Knowledge, Skills & Competencies
- Strong technical expertise and meaningful hands-on experience in microbial fermentation process development, scale-up and/or manufacturing in a drug development setting are required
- Proficient bioreactor/fermenter operation skills with solid understanding of fermenter control systems and scale-up principles are required
- Working knowledge of biologics purification techniques (e.g. UFDF, depth filtration, Chromatography) is a must
- Knowledge and experience with QbD and common risk assessment tools for process development and characterization are highly preferred
- Experience in Technical Transfer of GMP manufacturing processes for biologics is a plus
- Strong organizational skills with the ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment
- Proficient verbal and written communication skills
- Basic understanding of analytical methods utilized in microbial manufacturing process and drug development life cycle
- Bachelor’s experience in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline with 6+ years of relevant experience or Master’s with 4+ years of experience.
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.
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