Principal Scientist QA

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

Position Brand Description

Early Phase Quality Assurance (GMP Quality) accountable for the PR&D Early Phase Team, providing day-to-day Quality oversight of Early Phase Teams and external partners to execute the early phase development portfolio.

Key Objectives/Deliverables

• Support delivery of early phase pre-commercialization information/materials (typically through Phase II), ensuring quality expectations are met.
• Execute Early Phase Quality System to sustain compliance with regulatory requirements and GMP.
• Review and approve manufacturing documentation.
• Disposition API, in-process materials, dosage forms, and finished drug product for Clinical Trials (including review of GMP documentation, analytical results, and regulatory commitments).
• Coordinate deviation and complaint investigations; review/approve deviations, change documents, and specifications.
• Provide QA input to CM&C Development Plans.
• Qualify contract manufacturers/packagers, testing labs, vendors, and suppliers; oversee partner activities to optimize compliance and efficiency.
• Collaborate with internal partners (SMDD, BR&D, PD, ELECTS) to ensure appropriate oversight of external Early Phase activities.
• Provide on-site support for manufacturing/packaging/labeling of investigational medicinal products (as needed).
• Participate in continuous improvement; ensure inspection readiness (self-assessments, GMP education, quality systems, support for internal/regulatory inspections).

Minimum Requirements

• 5+ years professional experience; global clinical trial cGMP experience.
• Breadth of technical/quality knowledge (at least 2): API, drug product manufacturing, clinical trial packaging, analytical labs, ADC.
• Large Molecule manufacturing and Antibody Drug Conjugation experience.
• Interpret/apply phase-appropriate GMP; proficiency with applicable computer systems.
• Strong communication; critical thinking/problem-solving (root cause analysis); attention to detail.
• Data handling/integrity experience; change management; deviation management/investigations.

Additional Preferences

• Independent/team issue resolution; prior QA/QC/Operations/TS/MS/Engineering/Regulatory experience.
• PR&D Quality Systems and/or CT Operations knowledge; cGMP auditing experience.

Education

• Bachelor’s degree in a Science-related field or Engineering, or equivalent experience.

Other Information

Travel US and OUS (including India and China) required (10–20%).

Compensation/Benefits

• Anticipated wage: $65,250–$169,400. Company bonus eligibility and comprehensive benefits (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being benefits).