Senior Director, Quality Control Analytical Sciences

Role Summary

We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to lead QC Analytical Sciences across Apogee’s pipeline. This individual will be an important leader driving the TechOps and CMC Regulatory strategy, reporting to the VP of Analytical Development and Quality Control.

Responsibilities

• Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing; in-process/release/stability testing; specification justification and maintenance; shelf-life management; and critical documentation
• Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing
• Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
• Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner
• Monitor data trends, troubleshoot QC method performance, and investigate OOT/OOS results

Qualifications

• PhD in relevant discipline (e.g., analytical biochemistry or relevant field)
• 15+ years of QC experience with complex biologics, particularly monoclonal antibodies, spanning late-stage development and commercialization
• Proven people leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
• Excellent communicator with an ability to present to and be understood by a variety of stakeholders and tailor message accordingly
• Experience with regulatory filing preparation and messaging across global jurisdictions
• Deep knowledge and understanding of relevant global regulatory guidance and requirements
• Ability to keep pace with a fast-moving organization
• Availability to participate in calls across multiple international time zones
• Successfully exhibit Apogee‚Äôs C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 30%

Skills

• Analytical method development and validation
• QA/QC regulatory strategies
• GMP-compliant quality systems
• Regulatory documentation and Module 3 preparation
• Cross-functional collaboration

Education

• PhD in a relevant field