Process Engineer Job Listing at Kelly Services in Cambridge, MA (Job ID 9560426)

Description

Kelly Science & Clinical is seeking a Process Engineer (Formulation Development) for our client based in Cambridge, MA.

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.  

 Preferred Qualifications:

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. 

For immediate consideration, please apply. 

#EX2BIO2024

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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