Analytical Development Principal Scientist, Microbiology & Viral Safety

Scorpion Therapeutics; Boston (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics seeks a Principal Scientist in Analytical Development focusing on Microbiology & Viral Safety. You will lead strategic microbiology and virology testing for cell and gene therapy, biologics, and advanced therapies.

The role involves developing, validating, transferring and managing assays and partnering across functions to support regulatory submissions and manufacturing. The ideal candidate has a PhD with extensive industry experience in assay development and lifecycle

Qualifications

• PhD/MS/BS with 4+ / 7+ / 10+ years of industry assay development experience.
• Experience in regulatory standards and inspections is essential.
• Cell and gene therapy/biologics knowledge is preferred.

Responsibilities

• Develop, qualify, validate, transfer, and manage microbiology and viral safety assays.
• Support process development, regulatory submissions, and manufacturing.
• Author technical documents and drive risk assessments and rapid testing strategies.
• Represent and collaborate with cross-functional teams and external partners, ensuring GMP compliance.

Skills

Assay development

Assay validation

Lifecycle management

Assay evaluation

Regulatory standards

Regulatory inspections

Education

PhD in Microbiology/Virology or related field

MS in Microbiology/Virology or related field

BS in Microbiology/Virology or related field

Job description

Role: Principal Scientist, Analytical Development – Microbiology & Viral Safety, providing strategic leadership in microbiological and virological testing for cell and gene therapy, biologics, and advanced therapies.

Responsibilities include developing, qualifying, validating, transferring, and managing microbiological and viral safety assays, supporting process development, regulatory submissions, and manufacturing. The role involves authoring technical documents, guiding risk assessments, and driving innovation with rapid microbiological methods. Collaboration spans cross-functional teams and external partners, with emphasis on regulatory compliance, especially GMP and health authority interactions. The position requires hands-on wet lab work and representation in scientific forums.

Qualifications: PhD in Microbiology, Virology, or related field with 4+ years (PhD) or 7+ years (MS) or 10+ years (BS) of industry experience in assay development, validation, and lifecycle management. Skills in assay evaluation, regulatory standards, and experience supporting regulatory inspections are essential. Preferred expertise includes cell and gene therapy, biologics, adventitious agent safety, and familiarity with rapid testing strategies. Work setup: On-site, five days/week, with ad hoc flexibility; travel details are not specified.