Scientist, Analytical Development - Molecular Biology Method Development - ddPCR

Job Description

We are seeking a highly motivated Scientist with a strong background in molecular biology to join our Analytical Development Method Development Team. This is a unique opportunity to contribute to the development of innovative CAR T therapies and play a pivotal role in advancing method development for the characterization and quality control of gene-modified cell therapies. The successful candidate will apply their expertise in molecular biology assays, cell-based assays, and analytical method development to support the advancement of phase-appropriate assays used throughout the development lifecycle of CAR T products.

This is an exciting, hands-on opportunity to work in a dynamic environment where you'll have the chance to drive scientific innovation and method development at the forefront of gene therapy.

Key Responsibilities:

• Develop and execute molecular biology assays (e.g., qPCR, ddPCR, and ELISA) to assess the quality, potency, and safety of CAR T cell therapies.
• Develop and optimize cell-based assays to evaluate critical product attributes such as vector copy number, transduction efficiency, and/or cell functionality in the context of CAR T therapies.
• Collaborate with cross-functional teams to implement phase-appropriate analytical methods that support both preclinical and clinical stages of product development.
• Perform method qualification and validation of quantitative and qualitative assays, ensuring they meet regulatory and GxP standards.
• Contribute to the development of robust testing strategies to monitor critical quality attributes (CQAs) for CAR T therapies throughout the product lifecycle.
• Author and review technical documents such as SOPs, protocols, and reports in support of method development and analytical validation.
• Collaborate with Quality Control and Process Development teams to ensure alignment of analytical methods with manufacturing processes.
• Assist in the preparation of regulatory submissions, ensuring that analytical methods are adequately represented and comply with regulatory requirements.
• Apply strong troubleshooting and problem-solving skills to address challenges related to assay performance and data interpretation.
• Support the continuous improvement of method development processes to enhance the efficiency, accuracy, and reproducibility of assays.

Basic Qualifications:

• PhD in the field of Biological Sciences, or related field, with 0+ years of industry experience OR
• MS in Molecular Biology, Cell Biology, Immunology, or related discipline with 4+ years of industry experience OR
• BS in Molecular Biology, Cell Biology, Immunology, or related discipline with 6+ years of industry experience

Preferred Qualifications:

• Strong knowledge of molecular biology techniques (e.g., qPCR, ddPCR, ELISA, flow cytometry, etc.) and hands-on experience with cell-based assays.
• Two years of industry experience with MABs or cell therapy preferred
• Familiarity with analytical methods development for cell-based therapies, including the ability to translate scientific findings into robust testing strategies and phase-appropriate methods.
• Experience with method qualification and validation, with a focus on meeting regulatory and GxP compliance standards.
• Proficiency in data analysis software such as MS Excel, JMP, SoftMax Pro, or GraphPad Prism, and experience with statistical analysis for assay development.
• Strong scientific writing and documentation skills, with the ability to generate clear, concise reports, protocols, and SOPs.
• Excellent problem-solving skills and the ability to troubleshoot complex technical challenges related to assay development.
• Collaborative team player with excellent interpersonal, verbal, and written communication skills.
• Self-motivated, detail-oriented, and proactive, with a willingness to take on additional responsibilities as needed in a fast-paced, growing company.
• Comfortable working in a fast-paced, dynamic environment with the ability to adapt quickly to evolving project needs and priorities.

Why Join Us?

This is an exceptional opportunity to be part of an innovative company working at the forefront of CAR T and gene therapy development. By joining our Analytical Development Method Development Team, you will have the chance to shape the development of novel therapies, work with cutting-edge technologies, and contribute to improving patient outcomes. We offer a collaborative and dynamic environment where self-driven, enthusiastic individuals can thrive, make impactful contributions, and grow in their careers.