Overview As Principal Scientist, Analytical Operations, you lead QC strategy and operations to support small molecule clinical programs. You will ensure compliant testing, data integrity, and timely delivery across internal and external labs, shaping the analytical framework for development milestones. You'll partner across Analytical Development, Manufacturing, QA, Regulatory, and Supply Chain to drive phase-appropriate QC outcomes. This role is a bridge between science and compliance, enabling impactful clinical submissions and patient-focused therapies.
Compensation / Benefits- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
- comprehensive benefits package
- medical, dental, vision, and life insurance
Responsibilities- Define and implement the QC strategy for small molecule clinical programs aligned with CMC and quality objectives
- Oversee method validation/transfer, reference materials, specifications, cGMP release testing, stability strategy, and external lab testing
- Develop phase-appropriate QC processes to support manufacturing and regulatory submissions
- Manage specifications and ensure they are scientifically sound and aligned with analytical capability and regulatory expectations
- Represent QC on cross-functional product development teams and provide analytical quality direction
- Identify opportunities to improve QC testing, workflows, data management, and compliance
- Identify and escalate QC risks, communicating activities and issues to stakeholders
- Oversee QC testing of raw materials, intermediates, drug substance, and drug product
- Ensure timely creation/review/approval of QC documentation (methods, protocols, reports, CoAs) and quality records
- Provide QC oversight to external laboratories and coordinate testing for on-time delivery
- Investigate QC testing issues with root-cause analysis, risk assessment, and CAPAs
- Ensure compliance with cGMP, FDA, EMA, ICH, and related regulations
- Drive data integrity, documentation practices, and traceability across QC activities
- Draft/review CMC sections for regulatory filings and responses to RTQs
- Collaborate with Analytical Development, Manufacturing, QA, Regulatory, and Supply Chain throughout the product lifecycle
- Support technology transfer and method implementation at internal and external laboratories
- Contribute QC input to product development and regulatory submission documentation
Key requirements- 10+ years' experience with a BS OR 8+ years with an MS OR 5+ years with a PhD or PharmD in a related field
- Deep knowledge and hands-on leadership in small molecule pharmaceutical analytical testing and quality control
- Experience establishing analytical specifications and authoring CMC sections of regulatory submissions
- Strong understanding of regulatory and phase-appropriate QC expectations for clinical development
- Proven experience managing testing activities at external testing laboratories
- Excellent scientific judgement, communication, cross-functional collaboration, and influencing skills
- Ability to organize, plan, and execute multiple tasks with flexibility
- Independent problem-solving with strategic resource planning
- Knowledge of medical devices and combination products is a plus
- People Leader Accountabilities: inclusion, talent development, and empowering teams
- excellent communication
- cross-functional collaboration
- influencing skills
- small molecule analytical testing
- cGMP operations
- method validation and transfer
