Senior Director, Quality Control Analytical Sciences Jobs

Apogee Therapeutics

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Category:
Research and Development

Contract Type:
Not provided

Salary:

245000.00 - 260000.00 USD / Year

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Job Description:

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.

Job Responsibility:

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

Requirements:

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’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel up to 30%

What we offer:

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Additional Information:

Job Posted:
December 06, 2025

Employment Type:

Fulltime

Work Type:

Remote work

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Senior Director, Quality Control Analytical Sciences