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Process Engineer for Gene Editing and Critical Components Development

2 months ago

Cambridge Massachusetts, United States Editas Medicine Full time
About the Role

We are seeking a highly motivated Process Engineer to join our Technical Development Department in the in vivo Gene Editing and Critical Components Process Development team at Editas Medicine.

Key Responsibilities
  • 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
Requirements
  • 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
  • Strong technical expertise and meaningful hands-on experience in mRNA/LNP formulation development, scale-up and/or manufacturing in a drug development setting are required
  • Proficient UFDF/Dialysis operation skills with solid understanding of scale-up principles
  • Proficient verbal communication and technical writing skills
Preferred Qualifications
  • Solid knowledge and experience with QbD and common risk assessment tools for process development and characterization are highly preferred
  • Working knowledge of general downstream purification techniques (e.g. depth filtration, Chromatography) is a plus
  • Experience in molecular biology and microbial manufacturing of nucleic acids or protein are preferred
  • Experience in Technical Transfer of cGMP manufacturing processes and regulatory filing support for biologics
  • Working knowledge of mRNA, LNP and pertinent raw material (e.g. lipids) characterization methods and specifications is highly preferred
  • Strong organizational skills with the ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment
Benefits

Editas Medicine 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.