Research Associate - GEM Plasmid Production Facility

Roswell Park Comprehensive Cancer Center

2d

About The Position

The Research Associate will support the development and production of research- and GMP-grade plasmid DNA within the Plasmid Production Facility. This role will focus on molecular cloning, construct design, and upstream/downstream process development to enable robust, scalable, and regulatory compliant plasmid manufacturing in support of cell and gene therapy programs. The ideal candidate has strong bench skills in molecular biology and cloning, experience with bacterial expression systems, and an interest in translating laboratory methods into standardized, phase-appropriate manufacturing processes.

Requirements

• Master’s degree and the equivalent of eighteen (18) months of full-time professional research experience in a laboratory, clinical or scientific research environment; or
• Bachelor’s degree and the equivalent of thirty (30) months of full-time professional research experience in a laboratory, clinical or scientific research environment.
• NOTE: Required degrees must have been granted by an accredited school, college or university or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices.
• 2–3 years of hands-on industry experience in biopharmaceuticals, synthetic biology, molecular biology, or plasmid production.
• Experience working in a GMP, GLP, or similarly regulated environment (even academic GMP or process development labs).
• Strong proficiency in molecular cloning, including seamless/Gibson cloning, Golden Gate, or other assembly methods.
• Experience with E. coli–based plasmid production, including shake flask and (ideally) small bioreactor work.
• Familiarity with downstream plasmid purification
• Experience with analytical QC methods such as qPCR, agarose gel electrophoresis, HPLC/UPLC, endotoxin testing, or OD600–based growth monitoring.
• Experience writing or revising SOPs, batch records, development reports, or deviation/investigation documents.
• Understanding of cGMP principles, data integrity, and phase‑appropriate documentation.

Responsibilities

• Molecular Cloning and Construct Development •Design and generate plasmid constructs for use in GMP plasmid production •Perform routine and advanced molecular biology techniques, including: oDNA isolation and purification oPCR and qPCR oRestriction digestion and ligation oColony screening and clone verification •Interpret sequencing and analytical data to select and document final plasmid constructs. •Maintain detailed records of plasmid maps, sequences, and lineage in electronic systems.
• Process Development (Upstream and Downstream) •Support development and optimization of plasmid production processes in E. coli, including: oStrain selection and characterization oShake flask and bioreactor growth studies oMedia and feed strategy optimization oInduction and harvest parameters •Assist with downstream process development for plasmid purification, including clarification, chromatography, precipitation, filtration, and concentration steps. •Perform small-scale and scale-down studies to evaluate process robustness, yield, and product quality attributes. •Analyze process data and contribute to development reports, technology transfer documents, and batch records.
• GMP Readiness and Laboratory Operations •Execute studies and experiments following written procedures, development protocols, and applicable quality standards. •Draft and review technical documents such as standard operating procedures (SOPs), test methods, and development reports. •Support the transition of processes into GMP operations by contributing to process descriptions, risk assessments, and tech transfer packages. •Maintain laboratory equipment, inventory, and general lab organization in collaboration with the broader team. •Adhere to safety guidelines and maintain compliance with institutional biosafety and quality policies.
• Cross-functional Collaboration •Work closely with Quality Control, Quality Assurance, and other GEM staff to ensure process alignment and manufacturability. •Participate in team meetings to present data, troubleshoot issues, and propose improvements. •Support investigations, deviations, and continuous improvement initiatives related to plasmid process performance and quality.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees