Associate Director, Quality Control – Analytical Sciences
Related skills
gmp mass spectrometry microbiology hplc elisa📋 Description
- Lead QC Analytical Sciences testing across the development pipeline.
- Provide technical and operational oversight of analytical testing.
- Collaborate with cross-functional teams and external partners.
- Oversee product release, stability programs, and regulatory submissions.
- Manage multiple parallel activities across development stages.
- Harmonize QC analytical methods across labs and vendors.
🎯 Requirements
- Advanced degree in analytical chemistry, biochemistry, or related field
- 7+ years in analytical development and QC for complex biologics (GMP)
- Proficiency in HPLC, spectrophotometry, MS, ELISA, bioassays
- Strong knowledge of FDA, EMA, ICH regulatory requirements
- Hands-on regulatory submissions experience (INDs, BLAs/NDAs)
- Excellent communication and cross-functional collaboration
🎁 Benefits
- Competitive compensation and benefits: base, bonus, equity, health, retirement
- Paid time off: 3 weeks PTO, two shutdowns, sick leave
- Professional development and growth opportunities
- Dynamic, fast-paced environment with growth and impact
- All-hands meetings to build relationships and problem solve
- C.O.R.E. values and inclusive culture
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