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Apogee Therapeutics · 18 hours ago

Associate Director, Quality Control – Analytical Sciences

United States

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$165K/yr - $185K/yr

7+ years exp

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing differentiated biologics for various inflammatory and immunology conditions. The Associate Director will lead the QC Analytical Sciences team, overseeing analytical testing to support product development and ensuring compliance with regulatory requirements.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

Responsibilities

Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations

Partner with global and cross-functional teams to ensure successful implementation of harmonized methods

Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements

Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues

Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines

Generate and review technical documents, including protocols, reports, and method lifecycle documents

Qualification

Analytical developmentQuality controlRegulatory submissionsAnalytical techniquesGMP experienceTechnical documentationMulti-taskingC.O.R.E. valuesCommunication skillsCollaboration

Required

Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field)

7+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development (GMP experience required)

Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology

Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation

Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections

Excellent communication skills with an ability to collaborate effectively across functional lines

Ability to work independently and multi-task in 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

Position requires up to 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

We provide competitive time off, including 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

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)