Dir, Project Management

Muckelab

Analytical testing development transfer validation
Biopharmaceutical manufacturing industry
Analytical data interpretation troubleshooting
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

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.
  • The position will involve direct contact with government laboratories and functions in China (for example CDE and NIFDC) in addition to Contract Manufacturing and Contract Testing Organizations.
  • Lead and/or participate on global cross-functional teams and work effectively with multiple disciplines and personalities to facilitate rapid licensure and approval of commercial product extensions for our company’s biologics and vaccines.

Matching 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.

Skills & Requirements

Must-have

  • analytical testing development transfer validation
  • biopharmaceutical manufacturing industry
  • analytical data interpretation troubleshooting
  • scientific technical leadership troubleshooting
  • regulatory-CMC topics compendia
  • organizational project management skills
  • oral written communication skills

Nice-to-have

  • large molecule method development validation transfer
  • deviation management change control processes
  • laboratory data management systems
  • software automation digital systems

Key Requirements

  • Bachelor’s Degree (BA/BS) with 12 years of relevant industry knowledge
  • Master’s Degree (MA/MS) with 8 years of relevant industry knowledge
  • PhD with 4 years of relevant industry knowledge
  • Experience in biopharmaceutical manufacturing industry
  • Familiarity with regulatory-CMC topics and regulatory compendia

Work Rights

Not specified

Tailored Resume

Cover Letter