Dir, Project Management

Merck & Co., Inc., Rahway, NJ, USA

Large molecule analytical sciences
Global technical oversight
Commercial product lifecycle management
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

  • Large Molecule Analytical Sciences
  • Global technical oversight
  • Commercial product lifecycle management
  • China local testing requirements
  • Government and contract testing labs
  • Establish and maintain professional relationships
  • Support test method establishment
  • Troubleshoot technical issues
  • Facilitate logistics activities
  • Global cross-functional teams
  • Communicate challenges and opportunities
  • Influence regulatory compendia updates
  • Author regulatory and technical documentation
  • Communicate with regulatory agencies

Nice-to-have

  • Biopharmaceutical manufacturing industry
  • Analyze, interpret, and troubleshoot analytical data
  • Positive, proactive, and service-oriented mindset
  • Scientific, technical leadership, and troubleshooting skills
  • Familiarity with regulatory-CMC topics
  • Strong organizational and project management skills
  • Strong oral and written communication skills
  • Large molecule method development, validation, and/or transfer experience
  • Knowledge of deviation management and change control processes
  • QC Laboratory Due Diligence Experience
  • Experience with laboratory data management systems
  • Experience with 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
  • Concentration in biology, chemistry, biochemistry, or related science
  • Experience in the biopharmaceutical manufacturing industry
  • Ability to analyze, interpret, and troubleshoot analytical data
  • Demonstrated strong and broad-based scientific, technical leadership, and troubleshooting skills
  • Strong organizational and project management skills
  • Strong oral and written communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter