Associate Director, Quality Control – Analytical Sciences

We are seeking an Associate Director to join the QC Analytical Sciences team in Analytical Development & Quality Control to lead the execution and provide technical and operational oversight of analytical testing to support product development and quality control activities across Apogee’s pipeline. This role focuses on performing and supporting QC testing, method lifecycle activities, and data review to ensure compliance with cGMP and regulatory requirements. Working closely with cross-functional teams and external partners, this individual will be an important member of the TechOps team, contributing hands-on expertise to product release, stability programs, and regulatory submissions across the development pipeline, by managing multiple parallel activities at all stages of product development.

Key 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.

Ideal Candidate

• 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

The anticipated salary range for candidates for this role will be $165,000 - $185,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.