Research Associate - GEM Plasmid Production Facility

About the role

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.

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:
• DNA isolation and purification
• PCR and qPCR
• Restriction digestion and ligation
• Colony 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:
• Strain selection and characterization
• Shake flask and bioreactor growth studies
• Media and feed strategy optimization
• Induction and harvest parameters
• Auxiliary 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
• 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

Qualifications

• Required Education and Experience
• 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.
• 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.

Pay and Benefits

The starting salary for this position is $59,537 and this includes a full comprehensive benefits package.