Dir, Project Management

leHACK

Rahway, New Jersey, USA
Not specified
Analytical testing development
Troubleshooting analytical data
Large molecule method validation
leHACK is seeking a Director of Project Management for its Global Quality - Large Molecule Analytical Sciences team in Rahway, New Jersey. The role involves overseeing analytical oversight for large molecule products, particularly in China, requiring strong technical leadership and regulatory knowledge

Job Summary

  • This position will influence life-cycle management of our company’s commercial products and include a specific focus on support of local testing requirements for our company's large molecule commercial products in China.
  • Responsibilities include establishing and maintaining professional relationships with scientists in China's government and contract testing laboratories, supporting test method establishment, and facilitating logistics activities.
  • Influence development of new chapters/sections of regulatory compendia or updates to existing compendial chapters/sections including, but not limited to, those in the Chinese Pharmacopoeia.

Matching Summary

Match Score: 85

leHACK is seeking a Director of Project Management for its Global Quality - Large Molecule Analytical Sciences team in Rahway, New Jersey. The role involves overseeing analytical oversight for large molecule products, particularly in China, requiring strong technical leadership and regulatory knowledge.

Skills & Requirements

Must-have

  • analytical testing development
  • troubleshooting analytical data
  • large molecule method validation
  • cross-functional team leadership
  • stakeholder management
  • GMP laboratory experience

Nice-to-have

  • service-oriented mindset
  • proactive communication
  • cultural competence
  • risk management skills

Key Requirements

  • Bachelor’s Degree with 12 years of relevant industry knowledge
  • Master’s Degree with 8 years of relevant industry knowledge
  • PhD with 4 years of relevant industry knowledge
  • Biopharmaceutical manufacturing industry experience
  • Familiarity with regulatory-CMC topics and regulatory compendia

Work Rights

Not specified

Tailored Resume

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