Director, External Large Molecule Analytical

med-in.at

Not specified
Large molecule analytical sciences
Global technical oversight
China local testing requirements
The Director, External Large Molecule Analytical position at med-in.at focuses on managing analytical oversight for large molecule products, particularly in the Chinese market. The role requires extensive experience in the biopharmaceutical industry, with responsibilities that include interaction with regulatory bodies, technical problem-solving, and facilitating project communication

Job Summary

  • The Global Quality - Large Molecule Analytical Sciences (GQ-LMAS) team leads the global analytical technical oversight of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support for Large Molecules (Vaccines and Biologics), and Cross-Modality Compounds (e.g. Antibody-Drug Conjugates).
  • 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.

Matching Summary

Match Score: 85

The Director, External Large Molecule Analytical position at med-in.at focuses on managing analytical oversight for large molecule products, particularly in the Chinese market. The role requires extensive experience in the biopharmaceutical industry, with responsibilities that include interaction with regulatory bodies, technical problem-solving, and facilitating project communication.

Skills & Requirements

Must-have

  • Large Molecule Analytical Sciences
  • Global technical oversight
  • China local testing requirements
  • Direct contact with government laboratories in China
  • Establish and maintain professional relationships
  • Support establishment of test methods
  • Troubleshooting assistance for testing laboratories
  • Facilitate logistics activities
  • Global cross-functional teams
  • Proactive and timely communication
  • Influence development of regulatory compendia
  • Coordinate internal company reviews
  • Author regulatory and technical documentation
  • Participate in communications with regulatory agencies

Nice-to-have

  • Positive, proactive, and service-oriented mindset
  • Strong organizational and project management skills
  • Cross-cultural competence

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 the biopharmaceutical manufacturing industry
  • Ability to analyze, interpret, and troubleshoot analytical data
  • Demonstrated strong and broad-based scientific, technical leadership, and troubleshooting skills
  • Familiarity with regulatory-CMC topics and regulatory compendia
  • Strong organizational and project management skills
  • Strong oral and written communication skills

Work Rights

Not specified

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