Senior QA Scientist, Early-Phase GMP

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

401(k)

Medical/dental/vision

Life insurance

Time off

Well-being benefits

Job summary

Scorpion Therapeutics seeks an Early Phase Quality Assurance professional to provide day-to-day GMP quality oversight across the PR&D Early Phase Team and external partners, ensuring quality is integrated into development through Phase II.

Responsibilities include reviewing manufacturing documentation, disposition of API and dosage forms for clinical trials, and coordinating deviations and investigations to sustain inspection readiness and regulatory compliance.

Qualifications

• Bachelor's degree is required in a science-related field or engineering.
• 5+ years of global clinical trial cGMP experience in QA/Operations.
• Experience with large molecule manufacturing and ADC processes.

Responsibilities

• Provide day-to-day GMP quality oversight for Early Phase teams and external partners.
• Review and approve manufacturing documentation for early-phase products.
• Disposition API, in-process materials, dosage forms, and finished drug product for Clinical Trials.

Skills

Quality Assurance

GMP

cGMP

Regulatory compliance

Analytical thinking

Root cause analysis

Education

Bachelor's degree in Science or Engineering

Job description

Scorpion Therapeutics seeks an Early Phase Quality Assurance professional to provide day-to-day GMP quality oversight across the PR&D Early Phase Team and external partners, ensuring quality is integrated into development through Phase II.

Responsibilities include reviewing manufacturing documentation, disposition of API and dosage forms for clinical trials, and coordinating deviations and investigations to sustain inspection readiness and regulatory compliance.