Sr. Scientist, Analytical Development

Scorpion Therapeutics; Norwood (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking an Analytical Program Lead (APL) to oversee analytical activities for biologics or vaccines, supporting regulatory filings (IND, BLA/MAA) and lifecycle management. The role requires a PhD with 5+ years in the field or an MS/BS with 8+ years of industry experience, focusing on biologics or vaccine analysis, method validation, and tech transfer.

100% onsite in Norwood, MA with collaboration across QC, Regulatory CMC, MS&T, and Manufacturing to ensure regulatory

Qualifications

• PhD with 5+ years of industry experience in biologics or vaccine analytical development or quality control; MS/BS with 8+ years in the same area.

Responsibilities

• Define and execute analytical strategies including specifications, control and comparability strategies.
• Author and review regulatory submissions and respond to health authority queries.
• Ensure analytical readiness for clinical and commercial manufacturing.
• Collaborate cross-functionally with QC, Regulatory CMC, MS&T, and Manufacturing.
• Identify and mitigate analytical risks.
• Mentor team members.

Skills

Analytical chemistry

Regulatory knowledge

Team leadership

Biologics/vaccines experience

Education

PhD in Analytical Chemistry/ Biochemistry/ Pharmaceutical Sciences

MS/BS in related field

Job description

Role: Analytical Program Lead (APL) overseeing analytical activities for biologics or vaccines supporting regulatory filings (IND, BLA/MAA) and post-approval lifecycle.

Responsibilities: define and execute analytical strategies including specifications, control and comparability strategies, method validation, process transfer, and lifecycle management; author and review regulatory submissions and respond to health authority queries; ensure analytical readiness for clinical and commercial manufacturing; collaborate cross-functionally with QC, Regulatory CMC, MS&T, and Manufacturing; identify and mitigate analytical risks; mentor team members.

Qualifications: Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related with 5+ years of industry experience, or M.S./B.S. with 8+ years in biologics or vaccine analytical development or quality control.

Preferred skills include expertise in biologics or nucleic acid therapeutics, regulatory justification, ICH and GMP knowledge, experience with BLAs/MAAs, and support for technology transfer and validation.

HighValue: biologics/vaccines, late-stage development, IND/BLA/MAA support, analytical control strategies, regulatory authoring, cross-functional collaboration.

WorkSetup: 100% onsite; no travel specified.