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.
Minimum Requirements:
- PhD or equivalent in Biological Sciences or related field plus 1 year of relevant experience. Alternatively, will accept Master’s degree or equivalent in Biological Sciences or related field plus 4 years of relevant experience.
Must Have:
Experience in a Biotechnology setting, particularly cell therapy, pluripotent stem cells, gene editing. Extensive experience with cell characterization methods and analytical technologies, such as imaging, cell-based assays, qPCR, qPCR/ddPCR, RNAseq, functional assays, and mammalian cell culture is required. Experience with Good Documentation Practices and working in a cGMP or equivalent environment. Experience in qualification, validation, transfer, and life cycle management of analytical methods. Experience with writing technical reports, and regulatory documents presenting data clearly and concisely. Excellent organizational and problem-solving skills, with demonstrated ability to work cross-functionally. Excellent written and oral communication skills, with strong organizational skills and keen attention to detail. Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).
Salary:
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