Associate, Internal Quality Control Operations

Lilly

Boston, MA, USA
Base: $71,250 - $161,700; bonus/equity: compyny bo...
Cgmp analytical testing experience
Oos and oot investigation leadership
Team management in qc environment
The role supports cGMP analytical testing of various gene therapy products while ensuring product integrity and regulatory compliance

Job Summary

  • The role supports cGMP analytical testing of various gene therapy products while ensuring product integrity and regulatory compliance.
  • Candidates will lead investigations into out-of-specification results, identify root causes, and implement effective corrective actions.
  • Lilly offers a comprehensive benefit program including medical, dental, vision, 401(k), and wellness benefits to eligible employees.

Matching Summary

The role supports cGMP analytical testing of various gene therapy products while ensuring product integrity and regulatory compliance.

Salary

Base: $71,250 - $161,700; Bonus/Equity: Company bonus depending on performance; Benefits: Medical, dental, vision, 401(k), pension, vacation

Skills & Requirements

Must-have

  • cGMP analytical testing experience
  • OOS and OOT investigation leadership
  • Team management in QC environment
  • Method qualification and validation
  • FDA regulations and ICH guidelines knowledge

Nice-to-have

  • Experience with LIMS software
  • Continuous improvement initiatives
  • Cross-functional collaboration skills
  • Mentoring high-performing teams
  • Audit support experience

Key Requirements

  • Bachelor's degree in Chemistry or related field
  • Minimum 10 years QC experience in pharma/biotech
  • At least 2 years in leadership or management role
  • Authorized to work in the United States full-time

Work Rights

Must be authorized to work in the US on a full-time basis

Tailored Resume

Cover Letter