Associate Director- Bioanalytical Sciences, Translational Medicine and Nonclinical Development at BlueRock Therapeutics

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Cell Therapy, PharmaceuticalsIndustries

Requirements

PhD required
5+ years of industry and/or CRO experience required

Responsibilities

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

Skills

Bioanalysis

Biomarker Analysis

Translational Medicine

Nonclinical Development

Clinical Biomarkers

Preclinical Biomarkers

Assay Management

Stem Cell Therapy

Cellular Therapy

BlueRock Therapeutics

Develops advanced cellular therapies for diseases

About BlueRock Therapeutics

BlueRock Therapeutics develops advanced cellular therapies using a unique cell gene platform that directs cellular differentiation and genetically engineers cells. This technology allows them to create new types of medicines aimed at treating complex diseases in areas such as neurology, cardiology, and immunology. Their products work by transforming cells to target specific medical conditions, including neurodegenerative diseases, heart failure, and immune disorders. Unlike many competitors, BlueRock focuses on a specialized approach within the rapidly growing field of regenerative medicine, emphasizing strategic partnerships and research and development to advance their therapies. The company's goal is to address challenging medical conditions through innovative cellular treatments and to generate revenue through collaborations, licensing agreements, and eventual commercialization of their therapies.

Cambridge, MassachusettsHeadquarters

2016Year Founded

$218.9MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Hybrid Work Options

Risks

Competition from established firms like Johnson & Johnson may overshadow BlueRock's innovations.

Reliance on strategic partnerships poses risks if partners shift focus or resources.

Regulatory hurdles could delay product launches, impacting revenue and market position.

Differentiation

BlueRock uses iPSC technology to create novel cellular therapies for complex diseases.

Their strategic partnerships enhance R&D capabilities and expand therapeutic applications.

Focus on neurology, cardiology, and immunology addresses challenging medical conditions.

Upsides

FDA RMAT designation for bemdaneprocel accelerates market entry for Parkinson's therapy.

Successful Phase I trial of bemdaneprocel boosts investor confidence and funding potential.

Collaboration with bit.bio enhances discovery and development of new cell therapies.

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