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About the Role

The Senior Research Associate, Research will be a key technical contributor to a dynamic team pioneering scaled somatic cell manufacturing processes. This role is responsible for driving assay discovery and development, establishing critical characterization and quality assays for cell therapy products and manufacturing processes with minimal supervision.

Responsibilities

• Design and execute in vitro experiments to assess and develop novel assays/biomarkers, techniques, and technologies to characterize cell therapy development processes.
• Identify and determine appropriate ranges of critical assay process parameters for robust, repeatable, and accurate results with minimal supervision.
• Assess, design, develop, evaluate, and implement technologies, processes, and methods to improve understanding of therapeutic cell product candidates, intermediates, media, reagents, growth factors, and other materials critical to safety and quality.
• Ensure experiments, analytical methods, and data meet requirements for intended assay use (characterization, lot release, comparability).
• Perform flow cytometry, ELISA, analytical, cell-based, PCR-based, and other assays.
• Collect and analyze data from various assays, track and trend data, and establish specifications for critical process controls.
• Review and approve SOPs, study protocols, reports, and other scientific and quality documents.
• Ensure assays meet regulatory requirements in all relevant regions, in compliance with the Quality Management System.
• Identify and evaluate new technologies and incorporate them into product quality assessments.
• Perform technology transfer of assays to the Quality Unit through training and support of qualification/validation efforts.
• Present scientific data to colleagues in group meetings.
• Prepare and present internal and external presentations (presentations, posters, publications).

Requirements

• Bachelor’s degree or equivalent in Biological Sciences or related field plus 5 years of experience in a biotechnology or pharmaceutical industry setting.
• Master's degree or equivalent in Biological Sciences or related field plus 2 years of experience in a biotechnology or pharmaceutical industry setting.
• Proficiency in Flow Cytometry.
• Highly familiar with standard analytics equipment and procedures including, but not limited to ELISA, DNA/RNA analysis, cell-based and screening assays, protein analysis, sterility, mycoplasma, endotoxin, cell-counting, qPCR, ddPCR, IHC/pathology.
• Ability to solve a wide range of complex problems in creative and practical ways.
• Solid understanding of aseptic techniques and technologies.
• Demonstrated experience developing and optimizing biological and/or chemical assays.
• Proven ability to be highly productive and successful in a high-pace work environment with excellent attention to details and meticulous bench work.
• Competency in computer skills and familiarity with Microsoft Office programs (Word, Excel, PowerPoint).

Skills

• Flow Cytometry
• ELISA
• DNA/RNA analysis
• Cell-based assays
• Screening assays
• Protein analysis
• Sterility testing
• Mycoplasma testing
• Endotoxin testing
• Cell-counting
• qPCR
• ddPCR
• IHC/pathology
• Aseptic techniques
• Assay development
• Assay optimization
• Microsoft Office (Word, Excel, PowerPoint)

Location

• New York, NY

Work Type

• Full-time

Experience Level

• Senior

Education Level

• Bachelor's degree
• Master's degree

Salary/Compensations

• $96,054 to $117,000 per year

About the Company

• BlueRock Therapeutics, LP is pioneering scaled somatic cell manufacturing processes utilizing state-of-the art culturing technology at increasing scales.

Equal Opportunity

• An EOE.