Associate Principal Scientist, Analytical R&D

Scorpion Therapeutics; Pennsylvania; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Hybrid work setup

Travel opportunities

Job summary

Scorpion Therapeutics seeks a Lead for global analytical transfer activities focusing on large molecules, vaccines, and biologics within the GQ-LMAS team to support late-stage transfer, validation, and lifecycle management for commercialization.

The role involves overseeing international transfers, collaboration with manufacturing and testing sites including CMOs, and ensuring adherence to ICH, USP, and cGMP standards while managing risk and regulatory aspects.

Qualifications

• Bachelor’s degree in science with 6+ years (or Master’s with 4+ years, PhD with 1+ year) in biologics/large molecule development, validation, or QC.
• Strong knowledge of ICH, USP, and GxP practices.
• Experience in late-stage method transfer, validation, and cGMP labs.
• Project management and stakeholder communication.

Responsibilities

• Oversee complex analytical transfers
• Develop and troubleshoot assays
• Conduct risk assessments
• Manage international registration and import activities
• Collaborate with manufacturing and testing sites, including CMOs

Skills

Late-stage method transfer

Method validation

Project management

Stakeholder communication

Education

Bachelor's degree in science

Master's degree in science

PhD in science

Job description

Role: Lead global analytical transfer activities for large molecules including vaccines, mAbs, and biologics within the GQ-LMAS team, focusing on late-stage method transfer, validation, and lifecycle management to support commercialization.

Responsibilities

• oversee complex analytical transfers
• develop and troubleshoot assays
• conduct risk assessments
• manage international registration and import activities
• collaborate with manufacturing and testing sites, including CMOs

Requirements

• Bachelor’s degree in science with 6+ years (or Master’s with 4+ years, PhD with 1+ year) in biologics/large molecule development, validation, or QC
• strong knowledge of ICH, USP, and GxP practices
• experience in late-stage method transfer, validation, and cGMP labs
• project management skills
• effective communication and stakeholder management

Preferred

• experience with regulatory filings (IND, BLA, MAA)
• global launch support
• lean six sigma
• deviation/change control processes

High Value

• biologics, vaccines, mAbs, ADCs
• late-stage development
• regulatory submissions
• international manufacturing support
• cGMP environment
• 10% travel
• hybrid work setup