Principal Scientist, Analytical Operations

Scorpion Therapeutics; United States; On-site; USD 196,000 - 253,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Company-sponsored medical, dental, 1 2

Job summary

Scorpion Therapeutics in the United States seeks a Principal Scientist, Analytical Operations to lead QC strategy and oversee cGMP analytical testing supporting small molecule clinical programs.

The role requires hands-on leadership, external lab oversight, and deep regulatory knowledge to guide strategy, testing, and data integrity across QC activities and submissions.

Qualifications

• 10+ years in related field (BS) or 8+ years (MS) or 5+ years (PhD/PharmD)
• Hands-on leadership in small molecule analytical testing and QC.
• Experience with parenterals, medical devices, and combination products.
• Experience establishing analytical specifications; authoring CMC sections.
• Deep understanding of regulatory and phase-appropriate clinical QC expectations.
• Experience managing testing at external labs.

Responsibilities

• Define and lead QC strategy aligned with CMC/quality objectives.
• Oversee method validation/transfer, reference materials, specifications, cGMP release testing, and external labs.
• Ensure compliant QC testing for raw materials, intermediates, drug substance, and drug product.
• Draft/review CMC sections and respond to RTQs.
• Partner with Analytical Development, Manufacturing, QA, Regulatory, and Supply Chain.

Skills

Analytical testing leadership

Cross-functional collaboration

Regulatory knowledge

Scientific judgment

Project planning

Education

PhD/PharmD

MS

BS

Job description

As a Principal Scientist, Analytical Operations, act as a Quality Control (QC) Lead responsible for strategic oversight and operational execution of cGMP analytical testing supporting small molecule clinical development programs.

Focus Areas

Quality Control Leadership & Strategy

• Define, implement, and continuously improve QC strategy aligned with CMC/quality objectives.
• Point of contact for QC activities: method validation/transfer, reference materials, specifications, cGMP release testing, stability strategy/testing, and supervision at external contract labs.
• Develop/maintain phase-appropriate QC strategies and processes for manufacturing and regulatory submissions.
• Manage/approve specifications; establish scientifically sound, phase-appropriate specs aligned with analytical capability and clinical/regulatory expectations.
• Represent QC on cross-functional product development teams.
• Drive improvement in QC testing, workflows, data management, and compliance.
• Identify/escalate QC risks and communicate to stakeholders.

Analytical Testing & Documentation

• Ensure compliant QC testing execution for raw materials, intermediates, drug substance, and drug product.
• Oversee timely QC documentation (test methods, protocols, reports, CoAs, quality records).
• Oversee contract labs to ensure on-time delivery and cGMP/data integrity compliance.
• Lead timely resolution of QC testing investigations (root cause, risk assessment, CAPAs).

Compliance & Regulatory Affairs

• Ensure QC compliance with cGMP, FDA, EMA, ICH, and applicable regulations.
• Drive data integrity, documentation, and traceability.
• Draft/review CMC sections and supporting documents; respond to RTQs.

Cross-Functional Collaboration

• Partner with Analytical Development, Manufacturing, QA, Regulatory, and Supply Chain.
• Support technology transfer and method implementation.
• Provide QC input for product development and submission documentation.

Requirements & Qualifications

• 10+ years (BS) OR 8+ years (MS) OR 5+ years (PhD/PharmD) in a related field.
• Hands-on leadership experience in small molecule analytical testing and QC.
• Experience with parenterals, medical device, and combination products.
• Experience establishing analytical specifications; authoring CMC sections.
• Deep understanding of regulatory and phase-appropriate clinical QC expectations.
• Experience managing testing at external labs.
• Strong scientific judgment, communication, cross-functional collaboration, influencing.
• Ability to organize/plan multiple tasks with shifting priorities; think critically/creatively and work independently.

People Leader Accountabilities

• Create Inclusion; Develop Talent; Empower Teams.

Compensation/Benefits (as stated)

• Salary range: $195,670.00–$253,220.00.
• May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.