- Doctoral degree
- Master's degree
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Microsoft Office
- Organizational skills
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’ lives.
As part of BlueRock's vision to change the future of medicine by enabling ground-breaking cell therapies, we’re looking for a QC Analytical Scientist II, specialized in Cell Biology to support a dynamic and progressive analytical team. Expertise in performing and developing cell-based assays is required. Familiarity with work under GLP or GMP regulations is preferred.
Reporting to the Senior Analytical Scientist of Quality Control, the Analytical Scientist II 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 drive 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 standards, troubleshooting and training. The ideal candidate will be highly motivated and able to lead from the bench in 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:
From an in-depth knowledge of cellular biology, perform and evaluate advanced human cell culture activities and assays on cell therapy products, as part of an analytical QC team, including but not limited: Human Cell passaging, Cryopreservation, Cell counting (manual and automated) and microscopy, Plating/imaging assays, ELISA and Enzymatic Assays, Genomic stability
Champion assessing and implementing 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.
Liaise with project teams to establish and perform test transfer of scientifically sound QC test methods to be used for the release and/or characterization of cell therapies.
Establish and execute 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.
Act as Subject Matter Expert to support training of QC specialists in test methods and analytical instruments.
Lead 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 support the establishment of specifications for critical quality attributes.
Document experimental data in a timely and accurate manner following good documentation practices and in accordance with the company quality management system.
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.
Prepare and 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:
Master’s degree in Biological Sciences with Minimum of 11 years of relevant experience, or PhD in Biological Sciences with Minimum of 2 years of relevant experience.
Strong preference for experience in the Biotechnology setting, particularly cell therapy, stem cells, gene editing.
A solid understanding of aseptic techniques and technologies in cell culture is required.
Additional hands-on experience in one or more of the following techniques is preferred: Flow cytometry, ddPCR.
Practical understanding of qualification and/or validation of analytical assays.
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.
Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).
Demonstrated flexibility in adjusting to changing priorities and schedules.
Ability to work independently in a fast-paced, team-oriented organization.
Occasional weekend work on an as needed basis will be required.
Work Environment:
In this position you will work in a controlled laboratory environment
You may be periodically required to move heavy equipment around up to 50lbs
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
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BlueRock Therapeutics Company Culture Highlights Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023 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 Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/
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.
