Lead Analytical Scientist, Biologics & Vaccines (Regulatory)

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

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