Scientist I, Analytical & Quality Control

BlueRock Therapeutics•Cambridge, MA

1d•Hybrid

About The Position

The Scientist I, Analytical & Quality Control will be responsible for scientific coordination and support of analytical studies for BlueRock programs. This includes driving study design, protocol writing, experimental planning, logistical coordination, managing internal/external partners, data analysis, and report writing. The role also involves collaborating with local sites for execution. A key aspect of this position is assessing, designing, developing, evaluating, and implementing novel technologies, processes, and methods to enhance the understanding of therapeutic cell product candidates and other materials critical to the safety and quality of drug substance and drug product for patient use. The scientist will identify and determine appropriate ranges of critical assay process parameters to ensure robust, repeatable, and accurate results with minimal supervision. They will ensure that experiments, analytical methods, and data meet the requirements for their intended use, including 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 are also core responsibilities. Documenting experimental data in electronic laboratory notebooks accurately and in a timely manner, in accordance with the company's quality management system, is essential. The role involves authoring and reviewing SOPs, study protocols, reports, and other scientific and quality documents. Ensuring assays meet regulatory requirements in all relevant regions and comply with the Quality Management System is crucial. Identifying and evaluating new technologies and incorporating them into product quality assessments, as well as qualifying assays for use as Quality Control tools, are key functions. The position also includes performing technology transfer of qualified assays to the Quality Unit through training and support of further qualification/validation efforts. This is a hybrid role requiring 3 days/week in the office.

Requirements

PhD or equivalent in Biological Sciences or related field plus 1 year of relevant experience OR Master’s degree or equivalent in Biological Sciences or related field plus 4 years of relevant experience
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
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)

Responsibilities

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