BlueRock Therapeutics

Scientist I, Analytical & Quality Control

BlueRock Therapeutics • $113K — $140K *
Cambridge, MA 02139Hybrid
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • PhD or equivalent in Biological Sciences or related field plus 1 year relevant experience, or a Master's degree plus 4 years experience.
  • Experience in a Biotechnology setting, especially involving cell therapy and gene editing.
  • Extensive knowledge of cell characterization methods and analytical technologies.
  • Familiarity with Good Documentation Practices and cGMP environments.
  • Experience in analytical method qualification and validation.
  • Proficient in writing technical and regulatory documents.
  • Strong organizational and problem-solving skills, with cross-functional collaboration experience.

Responsibilities

  • Coordinate and support analytical studies for BlueRock programs, managing design, protocols, and partnerships.
  • Develop and implement new technologies and processes for therapeutic cell products.
  • Ensure analytical methods meet assay requirements for characterization and quality control.
  • Collect and analyze data, establishing specifications for critical controls.
  • Document experimental data in compliance with quality management standards.
  • Author and review SOPs, study protocols, and scientific documents.
  • Present scientific data in various formats for both internal and external audiences.

Benefits

  • Opportunity to work with cutting-edge technologies in cell therapy and biotechnology.
  • Engagement in meaningful scientific research that impacts patient safety.
  • Collaborative work environment with opportunities for cross-functional projects.
  • Hands-on laboratory work with a focus on developing new methodologies.
Full Job Description
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.
  • 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.
  • 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 Range: $113,464 to $140,000

#LI-AL1

About BlueRock Therapeutics

BlueRock Therapeutics is a biotechnology company that develops engineered cell therapies to cure diseases. The company's platform is based on induced pluripotent stem cells (iPSCs) and gene editing technologies. BlueRock Therapeutics is focused on developing therapies for diseases of the central nervous system, cardiovascular system, and immunology. The company was founded in 2016 and is headquartered in Cambridge, Massachusetts.
Learn more about BlueRock Therapeutics
Size
100 employees
Industry
Pharmaceuticals & Biotech
Founded
2016
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at BlueRock Therapeutics

More Pharmaceuticals & Biotech Jobs

Find similar Scientist I, Analytical & Quality Control jobs:

NationwideCambridge, MA