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Position Overview:

We are currently seeking a motivated, self-starting, and experienced scientific /technical leader with expertise in developing, qualifying, and validating a variety of assays that are critical for cell therapy product development. Working in a highly collaborative Technical Development Organization, the individual will contribute to the cell therapy programs through both knowledge/insight, hands-on work, and collaboration.

This is a scientific leadership and hands-on position where the successful candidate will contribute strategies and delivery on assays for the cell therapy drug product release and characterization. The ideal candidate will have extensive experience in multi-color flow cytometry, various immunological assays, and can collaborate effectively. This role will work closely with colleagues across the organization to advance Prime Medicine’s clinical development pipeline.

Key Responsibilities:

• Design, develop, optimize, qualify, and validate assays used to test cell therapy drug substances and drug products. For example, conduct and oversee all aspects of conventional and spectral flowcytometry assay methods.
• Build in-house analytical capability. Manage technology transfer to CDMOs and CTLs.
• Understand cell therapy quality attributes and suitable methodologies for testing and characterization, taking into considerations stage appropriate development needs. Recommend and implement testing methods for GxP and in-process samples.
• Deliver methods and sample characterization data. Present and communicate to teams on technical progress and data interpretations.
• Work with project teams, process development teams, analytical development colleague, and quality group to enable programs at different stages of clinical development.
• Maintain detailed and complete electronic lab notebooks and documentation records. Integrate workflows with ELN (Benchling) and LIMS to support GxP and regulatory filing requirements.
• Author, review, and approve protocols, SOPs, technical reports, and sections of regulatory submissions.
• Coordinate and work with various teams in a matrixed environment, as well as external CROs.

Qualifications/Requirements:

• PhD degree in a scientific discipline with plus 3-7 years’ relevant industrial experience or BS/MS plus 8+ years’ relevant industrial experience.
• Understand cell therapy quality attributes and suitable methodologies for testing and characterization.
• Experience in assay development, qualification, and validation in the drug development context. Extensive hand-on experiences in multi-color flow cytometry and various immunological assays.
• Demonstrated productivity and strong track records in delivery on corporate and group goals. knowledge in drug development process, CMC regulatory requirements is a plus.
• Experiences in working in multidiscipline teams and communicating complex data/decisions within department and cross functionally.
• Excellent oral and written communication skills, with the ability to influence and engage across all levels of the company and with external stakeholders, strong interpersonal skills.