Scientist I, Analytical & Quality Control

Specific responsibilities the Scientist I, Analytical & Quality Control include: Scientific coordination and support of analytical studies for BlueRock programs; driving study design, protocol writing, experimental planning, logistical coordination, managing internal/external partners, data analysis and report writing, collaborating with local sites for execution. Assessing, designing, developing, evaluating and implementing novel technologies, processes and methods to improve understanding of therapeutic cell product candidates and other material critical to safety and quality of drug substance and drug product for use in patients. Identifying and determining appropriate ranges of (critical) assay process parameters to ensure robust, repeatable and accurate results with minimal supervision. Ensuring that experiments, analytical methods and data meet the requirements for the intended use of assays, which includes characterization, lot release and comparability. Performing other cellular and molecular assays as required. Collecting and analyzing data from various assays, tracking and trending data and establishing specifications for critical process controls. Documenting experimental data in electronic laboratory notebooks in a timely and accurate manner in accordance with the company quality management system. Authoring and reviewing 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. Qualifying assays for use as Quality Control tools. Performing technology transfer of qualified assays to the Quality Unit through training of personnel and support of further qualification/validation efforts. Hands-on laboratory work as well as supervision of research associates and technicians. Presenting scientific data to colleagues in group meetings, preparing and presenting internal and external presentations (presentations, posters, publications). Performing additional duties to support the safe and efficient operation of the laboratory, and other duties as assigned. Hybrid role - must report to office 3 days/week.