Sr Manager/ad/director Of Qc

Bionova Scientific LLC

Base: $155,000 to $200,000; bonus/equity: not spec...
Bachelor of science degree in scientific field
Minimum 6 years analytical or quality control experience
Minimum 3 years gmp quality control laboratory experience
This role oversees all QC functions including Lab Operations, HPLC, Bioassay/ELISA, and raw material testing while ensuring compliance with Bionova quality standards

Job Summary

  • This role oversees all QC functions including Lab Operations, HPLC, Bioassay/ELISA, and raw material testing while ensuring compliance with Bionova quality standards.
  • The position requires deep expertise in quality systems, the ability to lead investigations for OOS/OOT events, and strong leadership capabilities to coach analysts and junior managers.
  • Bionova offers a comprehensive benefits package including 100% covered life insurance and disability, up to 8% employer 401k match, and competitive base compensation between $155,000 and $200,000.

Matching Summary

This role oversees all QC functions including Lab Operations, HPLC, Bioassay/ELISA, and raw material testing while ensuring compliance with Bionova quality standards.

Salary

Base: $155,000 to $200,000; Bonus/Equity: Not specified; Benefits: Health, Dental, Vision subsidized; 100% Life/Disability; 8% 401k Match; PTO/Holidays/Sick Leave included

Skills & Requirements

Must-have

  • Bachelor of Science degree in scientific field
  • Minimum 6 years analytical or quality control experience
  • Minimum 3 years GMP Quality Control Laboratory experience
  • Expertise in HPLC, bioassay/ELISA, and compendial testing
  • Experience with instrument qualification and method transfer
  • Knowledge of GMP regulations including 21 CFR and ICH
  • Proficiency with LIMS, Empower, and SoftmaxPro software

Nice-to-have

  • Leadership capability to influence global teams
  • Ability to drive Lean laboratory practices
  • Strong technical writing skills for procedures
  • Adaptability to frequent changes and delays
  • Experience leading investigations for deviations
  • Subject matter expert during client audits

Key Requirements

  • Bachelor of Science degree required
  • 6+ years in analytical or QC environments
  • 3+ years GMP QC lab experience
  • Working knowledge of 21 CFR, ICH, Eudralex
  • Expertise in statistical methods and trend analysis

Work Rights

Not specified

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