Manager, Qc Biochemistry (hopewell, Nj)

BeiGene

Hopewell, NJ, US
Base: $110,800.00 - $150,800.00 annually; bonus/eq...
Gmp manufacturing support
Qc biochemistry laboratory operations
Fda/eu regulations compliance
Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations

Job Summary

  • Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations.
  • Ensures Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards and timely completion of testing to support manufacturing operations.
  • The company offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs.

Matching Summary

Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations.

Salary

Base: $110,800.00 - $150,800.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Skills & Requirements

Must-have

  • GMP manufacturing support
  • QC Biochemistry laboratory operations
  • FDA/EU regulations compliance
  • Potency assays
  • Binding ELISA
  • Cell Culture
  • Residual Host Cell Protein (HCP)
  • Residual DNA testing

Nice-to-have

  • Highly motivated
  • Collaborative
  • Passionate interest in fighting cancer
  • Hands-on approach
  • Can do attitude
  • Self-motivated
  • Proactive work style

Key Requirements

  • 5-7 years working experience
  • 2 years managing laboratory analysts
  • Bachelor's Degree in Chemistry, Biochemistry, or Biotechnology
  • Experience in FDA-regulated biotechnology/pharmaceutical company
  • Direct experience in a GMP quality control lab
  • Familiar with instrument and equipment validation

Work Rights

Not specified

Tailored Resume

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