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Apogee Therapeutics · 10 hours ago

Senior Director, Quality Control Analytical Sciences

United States

Full-time

Remote

Senior Level, Lead/Staff

$245K/yr - $260K/yr

15+ years exp

Apogee Therapeutics, Inc. is a biotechnology company focused on developing differentiated biologics for treating various inflammatory and immunology indications. They are seeking a Senior Director, Quality Control Analytical Sciences to lead QC activities and drive regulatory strategies across their pipeline.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

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

Qualification

QC experienceAnalytical biochemistryRegulatory filing preparationMonoclonal antibodiesGMP compliancePeople leadershipGlobal regulatory knowledgeC.O.R.E. valuesCommunicationFast-paced adaptability

Required

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%

Benefits

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

Dedicated paid sick leave

Company

Apogee Therapeutics

Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.

Founded in 2022

San Francisco, California, USA

201-500 employees

https://apogeetherapeutics.com/

H1B Sponsorship

Apogee Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (3)