Senior Research Associate, Research

BlueRock Therapeutics • New York, NY

19h • $96,054 - $117,000 • Onsite

About The Position

The Senior Research Associate, Research will be a key technical contributor of a dynamic and progressive team pioneering scaled somatic cell manufacturing processes utilizing state-of-the art culturing technology at increasing scales. The role is responsible for driving assay discovery and development at BlueRock, establishing critical characterization and quality assays for cell therapy products and manufacturing processes with minimal supervision. The Senior Research Associate, Research will be a highly motivated individual who leads from the bench and enjoys having broad responsibilities and opportunities.

Requirements

• Bachelor’s degree or equivalent in Biological Sciences or related field plus 5 years of experience in a biotechnology or pharmaceutical industry setting. Alternatively, will accept a 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.
• Must be able to solve a wide range of complex problems in creative and practical ways.
• A solid understanding of aseptic techniques and technologies.
• Demonstrated experience developing and optimizing biological and/or chemical assays.
• A 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).

Responsibilities

• Designing and executing in vitro experiments to assess and develop novel assays/biomarkers, techniques and technologies to characterize cell therapy development processes.
• Identifying and determining appropriate ranges of (critical) assay process parameters to ensure robust, repeatable and accurate results with minimal supervision.
• Assessing, designing, developing, evaluating and implementing technologies, processes and methods to improve understanding of therapeutic cell product candidates, intermediates, media, reagents, growth factors and other material critical to safety and quality of drug substance and drug product for use in patients.
• Ensuring that experiments, analytical methods and data meet the requirements for the intended use of assays, which includes characterization, lot release and comparability.
• Performing flow cytometry, ELISA, analytical, cell-based, PCR-based and other assays.
• Collecting and analyzing data from various assays, track and trend data, and establishing specifications for critical process controls.
• Reviewing and approving SOPs, study protocols, reports and other scientific and quality documents.
• Ensuring that assays meet regulatory requirements in all regions relevant to the company, in compliance with the Quality Management System.
• Identifying and evaluating new technologies and incorporate them into product quality assessments as appropriate.
• Performing technology transfer of assays to the Quality Unit through training of personnel and support of further qualification/validation efforts.
• Presenting scientific data to colleagues in group meetings, prepare and present internal and external presentations (presentations, posters, publications).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior