Associate Director, Quality Control – Analytical Sciences

Apogeetherapeutics

Remote
$165,000 - $185,000 py
Remote
Analytical testing for biologics
Method lifecycle management
Cgmp compliance
Apogee Therapeutics is seeking an Associate Director for Quality Control in Analytical Sciences to oversee analytical testing and ensure compliance with regulatory requirements. The role requires extensive experience in analytical development, strong communication skills, and the ability to manage multiple projects in a fast-paced environment

Job Summary

  • Lead the execution and provide technical and operational oversight of analytical testing to support product development and quality control activities across Apogee’s pipeline.
  • Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements.
  • The company offers a great culture grounded in C.O.R.E. values and opportunities for professional growth in a fast-paced environment.

Matching Summary

Match Score: 85

Apogee Therapeutics is seeking an Associate Director for Quality Control in Analytical Sciences to oversee analytical testing and ensure compliance with regulatory requirements. The role requires extensive experience in analytical development, strong communication skills, and the ability to manage multiple projects in a fast-paced environment.

Salary

$165,000 - $185,000

Skills & Requirements

Must-have

  • analytical testing for biologics
  • method lifecycle management
  • cGMP compliance
  • regulatory submissions support
  • vendor technical oversight

Nice-to-have

  • harmonization of analytical methods
  • cross-functional collaboration
  • company culture alignment

Key Requirements

  • 7+ years of analytical development & quality control experience
  • Advanced degree in a relevant discipline
  • Experience with HPLC, spectrophotometry, mass spec, ELISA, bioassay, microbiology
  • Strong understanding of global regulatory requirements (FDA, EMA, ICH)
  • Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs)

Work Rights

Not specified

Tailored Resume

Cover Letter