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Associate Director, Quality Control – Analytical Sciences

3 weeks, 6 days ago
United States
Full-time
Senior
Manual QA Tester
Quality Assurance and Testing
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 22

Description

  • Lead the execution and provide technical and operational oversight of analytical testing for product development and quality control activities.
  • Support QC testing, method lifecycle activities, and data review to ensure compliance with cGMP and regulatory requirements.
  • Work with cross-functional teams and external partners to support product release, stability programs, and regulatory submissions.
  • Harmonize QC analytical methods across internal laboratories, external vendors, and contract testing organizations.
  • Partner with global teams to ensure successful implementation of harmonized methods.
  • Support method transfers, validations, and comparability studies in line with 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 and supporting technical documentation for clarity, accuracy, and compliance.
  • Generate and review protocols, reports, and method lifecycle documents.
  • Manage multiple parallel activities across all stages of product development.

Requirements

  • Advanced degree in a relevant discipline such as analytical chemistry, biochemistry, microbiology, or a related field.
  • 7+ years of analytical development and quality control experience with complex biologics across early- and late-stage development.
  • GMP experience is required.
  • Expertise in analytical techniques such as HPLC, spectrophotometry, mass spectrometry, ELISA, bioassay, and microbiology.
  • Strong understanding of global regulatory requirements, including FDA, EMA, and ICH, as they relate to analytical development, QC testing, and method validation.
  • Hands-on experience supporting regulatory submissions such as INDs, IMPDs, BLAs, NDAs, or equivalents, including preparation, review, and response to analytical sections.
  • Excellent communication skills and the ability to collaborate effectively across functional teams.
  • Ability to work independently and manage multiple priorities in a fast-moving organization.
  • Availability to participate in calls across multiple international time zones.
  • Up to 30% travel is required, including mandatory in-person attendance at Apogee All Hands meetings held typically twice per year.

Benefits

  • Market-competitive compensation and benefits package, including base salary, performance bonus, and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Commitment to professional growth, including access to resources for development.
  • Regular all-team in-person meetings to build relationships and solve problems.
  • Opportunity to work in a fast-paced, highly dynamic environment and help shape the company culture.

Interested in this position?

Apply directly on the company website

Apply Now

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