Site: Mass General Brigham Incorporated

 

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

 

Job Summary

The Gene and Cell Therapy Institute (GCTI) is a system-wide Institute under Mass General Brigham that fosters a world-class gene and cell therapy program, leveraging groundbreaking scientific research efforts across the MGB system. The mission of GCTI is to bring together the community of MGB investigators who use gene and cell therapy platforms to achieve their scientific and clinical goals and improve the health of patients. This position sits within the Wesselhoeft Laboratory at GCTI and is dedicated to the ARPA-H GIVE program, a multi-institution effort to build an automated continuous manufacturing platform that produces RNA–lipid nanoparticle drug product from digital sequence to vialed dose.

We are seeking a motivated and skilled Process Development Scientist to join our RNA Therapeutics team and lead the translation of RNA and lipid nanoparticle processes from benchtop protocols into a miniaturized, automated manufacturing platform. The candidate who fills this role will develop and optimize unit operations spanning DNA amplification, in vitro transcription, RNA capture and purification, LNP formulation, and fill and finish, and will define the process parameters, in-process controls, and analytics that govern them. They will design and execute rigorous studies to characterize process performance, establish operating ranges, and support technology transfer to the engineering partners building the device, independently or in collaboration with those partners. The successful candidate will have significant experience in RNA process development or manufacturing sciences, be proficient in standard molecular biology and purification techniques, be detail-oriented and organized, and eager to work in a highly collaborative, multidisciplinary team environment.

Essential Functions

• Develop, optimize, and characterize RNA and LNP unit operations, including in vitro transcription, capping, affinity capture, tangential flow filtration, and nanoprecipitation, for continuous manufacturing
• Translate benchtop processes into miniaturized and automated formats in collaboration with microfluidics, hardware, and software engineers, and support design reviews and technology transfer to internal and external partners
• Generate high-quality circular RNA, mRNA, and RNA-LNP drug product using techniques such as in vitro transcription, silica and affinity purification, tangential flow filtration, HPLC, cloning, gel electrophoresis, plasmid outgrowth and purification
• Define critical process parameters and in-process controls, and execute design-of-experiment studies to establish operating ranges and demonstrate process robustness
• Perform analytical and in-line process monitoring techniques such as RiboGreen, capillary electrophoresis, dynamic light scattering, zeta potential, and Raman and record quality metrics, with a strong focus on accuracy and reproducibility in work
• Author and maintain process documentation, including protocols, batch records, development reports, and data packages supporting program milestones and deliverables
• Use universal safety precautions and proper personal protective equipment to protect self and co-workers from biohazardous materials; complete requisite trainings as appropriate
• Participate in lab and program meetings, communicate effectively with the team and external partners, discuss progress, share data with supervisors, and contribute to a positive work environment
• Potentially manage one or more direct reports, assign tasks, and ensure high quality of work

 

REQUIRED COMPETENCIES:

• PhD with 3+ years of related experience in a life sciences laboratory, process development, or biomanufacturing role
• Experience synthesizing and purifying RNA via in vitro transcription
• Experience developing, optimizing, and transferring biologics or nucleic acid unit operations
• Ability to identify problems and troubleshoot solutions
• Well-versed in laboratory standards and practices
• Good organizational skills, detail-oriented
• Reproducibility of work with accuracy
• Sound degree of computer literacy
• Ability to methodically record and analyze data
• Good interpersonal and communication skills
• Ability to demonstrate professionalism
• Dedication to excellence

 PREFERRED COMPETENCIES:

• Experience managing direct reports
• Experience with lipid nanoparticle formulation and physicochemical characterization
• Experience in a GMP or GMP-adjacent environment, or with quality-by-design and design-of-experiment methodology
• Experience with microfluidic, automated, or continuous processing systems
• Computational or coding skills, including data analysis and instrument automation

 

• This role is 100% onsite. The office is located at 65 Landsdowne Street in Cambridge, MA currently with future plans to relocate to the Charlestown Navy Yard

 

Onsite

 

65 Landsdowne Street

 

40

 

Regular

 

Day (United States of America)

 

0100 Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

 

Mass General Brigham Competency Framework