Process Engineer, Formulation Development
3 months ago
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.
Required Qualifications:
The ideal candidate will possess:
- 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.
Additionally, candidates with the following attributes are preferred:
- 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
Benefits Summary:
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.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.
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