As part of BlueRock Therapeutics vision to change the future of medicine by enabling ground-breaking cell therapies, the candidate 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 successful candidate will drive assay development at BlueRock, establishing critical characterization and quality assays for cell therapy products and manufacturing processes. Expertise in developing and qualifying molecular and cellular biology assays is required. The ideal candidate will be a highly motivated individual who leads from the bench and enjoys having broad responsibilities and opportunities. Collaboration with a highly-motivated, world-class team of scientists and engineers promises an exciting and engaging work environment for motivated, self-starting candidates. Familiarity with developing and validating assays under GLP or GMP regulations is a plus.
KEY DUTIES & RESPONSIBLITIES:
- Design and execute in vitro experiments to assess and develop novel assays, techniques and technologies to characterize cell therapy manufacturing processes. Identify and determine appropriate ranges of (critical) assay process parameters to ensure robust, repeatable and accurate results with minimal supervision.
- Champion 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.
- Ensure that experiments, analytical methods and data meet the requirements for the intended use of assays, which includes characterization, lot release and comparability.
- Perform DNA/RNA-based, cell-based, flow cytometry, ELISA, analytical and other assays as required.
- Collect and analyze data from various assays, track and trend data and establish specifications for critical process controls.
- Author and review SOPs, study protocols, reports and other scientific and quality documents.
- Ensure that assays meet regulatory requirements in all regions relevant to the company, in compliance with the Quality Management System.
- Identify and evaluate new technologies and incorporate them into product quality assessments as appropriate.
- Qualify and subsequently validate assays for use as Quality Control tools. Perform technology transfer of qualified and validated assays to the Quality Unit through training of personnel and support of further qualification/validation efforts.
- This position requires hands-on laboratory work.
- Present scientific data to colleagues in group meetings, prepare and present internal and external presentations (presentations, posters, publications) as required.
- Perform additional duties to support the safe and efficient operation of the laboratory, and other duties as assigned.
- Excellent interpersonal, verbal and written communication skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Shares relevant information openly and seeks appropriate input from others outside of the direct team; develops and maintains effective cross-functional working relationships and partnerships; responds positively and constructively to requests for support from across the organization
- Creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes
- Candidate will be working in office and controlled laboratory environments
- Work may periodically require moving heavy equipment and the ability to lift ~50 pounds
- There is a risk of potential exposure to chemicals and biohazards consistent with somatic cell therapy culture
- Working in the laboratory requires mandatory use of personal protective equipment
- B.Sc. or M.Sc. in Biological Sciences or related and a minimum of two years of relevant assay development experience, preferably in a biotechnology or pharmaceutical industry setting
- Highly familiar with standard testing procedures and equipment including, but not limited to, DNA/RNA analysis (extraction, QPCR, RT-QPCR), cell-based and screening assays, flow cytometry, ELISA, protein analysis, cell counting, High Content Analysis
- Significant experience in developing and optimizing biological assays is required
- Practical understanding of qualification and/or validation of analytical assays (e.g. to GLP or GMP regulations) and familiarity with Good Documentation Practices is a strong plus
- A solid understanding of aseptic techniques and technologies in cell culture is required
- Experience in statistical analysis of data is desired
- Cooperating with a larger team, must be able to solve a wide range of complex problems in creative and practical ways
- Skilled in initiating and managing projects of complex scope, including cross-functions
- 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 (Word, Excel, PowerPoint)
BlueRock Therapeutics is an equal opportunity employer and supports workforce diversity. BlueRock welcomes and encourages applications from people with disabilities. Accommodations are available by request for candidates taking part in all aspects of the selection process