Scientist I, Analytical & Quality Control

Who is BlueRock?
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinsons disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.
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. 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
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.
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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.