Research Associate - GEM Plasmid Production Facility jobs in United States
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Roswell Park Comprehensive Cancer Center · 10 hours ago

Research Associate - GEM Plasmid Production Facility

Roswell Park Comprehensive Cancer Center is a leading health research institution focused on cancer treatment and prevention. They are seeking a Research Associate to support the development and production of research- and GMP-grade plasmid DNA, focusing on molecular cloning and process development in a collaborative environment.

Responsibilities

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
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
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
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

Qualification

Molecular CloningGMP ExperienceE. coli Plasmid ProductionAnalytical QC MethodsSOP WritingTeam CollaborationAttention to DetailProblem Solving

Required

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

Benefits

Full comprehensive benefits package

Company

Roswell Park Comprehensive Cancer Center

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Welcome to Roswell Park Comprehensive Cancer Center, America's first cancer center founded in 1898 by Dr. Roswell Park.

Funding

Current Stage
Late Stage

Leadership Team

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David Hohn
CEO Emeritus
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Paul Visco
VP/ CTO - Chief Technology Officer
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