Associate Director- Bioanalytical Sciences, Translational Medicine and Nonclinical Development

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 Parkinson's 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.

The Associate Director of Bioanalysis, Translational Medicine and Nonclinical Development, will be expected to take on a highly visible role with internal and external stakeholders through the management of clinical and preclinical biomarker analysis for BlueRock's development programs.

The Associate Director will leverage their bioanalytical biomarker expertise to advance the company's pipeline. As part of the Translational Medicine and Nonclinical Development team, this role provides unique opportunity to impact the development of novel cell therapies in multiple therapeutic areas including neurology and ophthalmology. The position will be based in Cambridge, Massachusetts.

Minimum Requirements & Responsibilities :

• PhD required with 5+ years of industry and / or CRO experience required.
• Develop, and validate biomarker assays to support biomarker measurement in clinical samples, ensuring that methods meet health authority expectations and fit-for-purpose requirements.
• Manage and monitor bioanalytical activities at contract research organizations. Drive process improvements for assay lifecycle management, sample logistics, and data workflows.
• Partner with bioinformatics / data science teams to ensure high-quality data capture, curation, and transfer for downstream analysis.
• Provide bioanalytical biomarker expertise and oversight to program teams at all stages of drug development from research to clinical. Evaluate and implement emerging bioanalytical technologies to expand biomarker capabilities.
• Collaborate with Clinical and Biomarker Leads to ensure biomarker assays align with study endpoints and scientific objectives.
• Review and approve study plans, assay validation reports, and bioanalytical study reports. Contribute to biomarker sections of regulatory submissions

Working Environment :

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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.