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Position Overview:

We are currently seeking a motivated, self-starting, and experienced scientific technical leader with expertise developing, qualifying, and validating a variety of plate-based analytical assays. Experience with using automation platforms and/or automating the assays is desirable. These assays will include ELISAs, cell-based, and mix and read format for a variety of analyses ranging from early research programs, in vivo samples, process and product characterization, stability, release testing of critical reagents, drug substance (DS) potency, and drug product (DP) potency to support the research and technical development organizations.

The candidate will join and contribute to a talented and highly productive team focused on developing assays to support Prime’s full pipeline from research to the clinic, which utilizes automation to support execution and data analysis. The candidate will apply their expertise to develop biochemical, immunologic, and cell-based assays to quantify process residuals, project-specific proteins, uptake, infectivity, and activity after prime editor-mediated gene correction.

Key Responsibilities:

• Design, develop, optimize, qualify, and validate plate-based (ELISA, Cell-based, mix and read) assays.
• Support R&D teams by contributing data from developed assays on ex-vivo, in-vitro, and in-vivo samples.
• Generate, analyze, and present complex multi-factor experimental studies using software such as JMP, Minitab, Spotfire, Tableau, etc.
• Integrate workflows with ELN (Benchling) and LIMS to support scalability.
• Maintain detailed and complete electronic lab notebooks and documentation records.
• Author, review, and approve protocols, SOPs, technical reports, and sections of regulatory submissions
• Present findings to internal teams and represent Prime at external forums
• Coordinate and work with various teams in a matrixed environment, as well as external CROs

Qualifications/Requirements:

• PhD plus 3-6 years’ relevant industrial R&D experience or BS/MS plus 8+ years’ relevant industrial experience.
• Experience in assay development, qualification, validation, and implementation to support target candidate validation from Non-GxP to GMP environments.
• Experience automating lab procedures is highly desirable.
• Proficiency in cell culture, including primary cells, and BSL-2 safety
• Ability to work effectively on cross-functional teams with a willingness to roll-up-sleeves to get things done.
• Excellent communication and presentation skills, ability to influence and engage across all levels of the company and with external stakeholders; strong interpersonal skills/diplomacy, and negotiation skill.
• Eager to work collaboratively in a fast-paced, dynamic, entrepreneurial, and team-based setting.