Who is BlueRock?


BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.
The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.


What Are We Doing?


Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.
We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.
We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients\xe2\x80\x99 lives.


As part of BlueRock\'s vision to change the future of medicine by enabling ground-breaking cell therapies, we\xe2\x80\x99re looking for a Principal Analytical Specialist, specialized in Flow Cytometry to support a dynamic and progressive Analytical Sciences team. Expertise in developing and qualifying multi-colour flow cytometry assays is required. Familiarity with performing flow cytometry sample analysis under GLP or GMP regulations is a plus.


Reporting to the Analytical Scientist II of Quality Control\xe2\x80\x99s Analytical Science team, the Principal Analytical Specialist will be a key technical contributor of an analytical team establishing the QC testing methodology of cell-based therapeutics destined for human clinical trials, from starting stem cell materials to final differentiated cell therapy. The successful candidate will support the analytical lifecycle of methods in a GMP-compliant environment, including test transfers of methods into QC, qualification or phase-appropriate validation, establishment of reference materials, troubleshooting and training.


This is an exciting opportunity for a highly motivated individual to perform technically complex methods, solving a wide range of challenging problems in creative and practical ways with a collaborative approach across QC and Analytical groups.

Responsibilities:

• • Perform flow cytometry and other cellular analysis of cell therapy products, as part of an analytical QC team.
  • Assist with development and optimization of new multi-colour flow cytometry panels and other cellular assays as required.
  • Assess and implement new technologies, processes, and methods critical to safety and quality of cell seeds, banks, intermediates, drug substance and drug products for cellular therapeutics and other materials.
  • Execute test transfer of scientifically sound QC test methods to be used for the release and/or characterization of cell therapies.
  • Perform studies to qualify and/or validate QC test methods in a clinical phase-appropriate manner. Identify and determine appropriate ranges of (critical) assay parameters to ensure robust, repeatable, and accurate results.
  • Work with project teams to establish reference standard materials for PSC banks and differentiated cell products to support cell therapy programs.
  • Support laboratory investigations to evaluate out-of-specification and atypical results within QC methods, including troubleshooting of invalids and monitoring method performance.
  • Ensure that experiments, analytical methods, and data meet the requirements for the intended use of assays, which includes lot release, comparability and/or characterization.
  • Collect and analyze data from various assays, track and trend data and supporting the establishment of specifications for critical quality attributes. Perform other cellular and molecular assays as required.
  • Author and review SOPs, study protocols, reports, and other scientific and quality documents.
  • Recognize and address opportunities for standardization, efficiency and innovation while following flow cytometry best practices.
  • 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.

Minimum Requirements:

• • Minimum of a BSC or MSc degree in Biological Sciences, Immunology, or related field with a minimum of 6+ (MSc) or 7+ (BSc) years of relevant flow cytometry experience in a contract research organization, biotechnology, or pharmaceutical company, or similar industry environment.
  • Significant experience developing and optimizing multi-colour flow cytometry assays according to industry and best practice standards is required.
  • Demonstrated expertise in multi-colour flow cytometry procedures, equipment, and data analysis software (e.g., FlowJo), including experience with operation, maintenance, and daily calibration of cytometers.
  • Hands-on experience in mammalian cell culture, with a solid understanding of aseptic techniques is required.
  • Practical understanding of qualification and/or validation of analytical assays is an asset.
  • Commitment to high-quality research and documentation standards, data integrity, and flow cytometry best practices.
  • Experience with Good Documentation Practices and working in a cGMP or equivalent environment is preferred.
  • Experience in statistical analysis of data is desired.
  • Excellent written and oral communication skills, with strong organizational skills, and keen attention to detail.
  • Demonstrated flexibility in adjusting to changing priorities and schedules.
  • Ability to work independently in a fast-paced, team-oriented organization.
  • Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).
  • Occasional weekend work on an as needed basis will be required.

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BlueRock Therapeutics Company Culture Highlights
Winner of Comparably\'s Award for Best Company for Diversity 2022
Winner of Comparably\'s Award for Best Company for Women 2022
Winner of Comparably\'s Award for Best CEO 2022
BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.
Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.


Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics


Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.