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Senior Director, Pharmaceutical Development and Manufacturing

2 months ago

Reston, Virginia, United States The Higgins Group, Inc. Full time

About The Higgins Group, Inc.

The Higgins Group, Inc. is a leading pharmaceutical company dedicated to discovering and developing innovative medicines that transform the lives of patients. Our mission is to deliver exceptional drug discovery and development solutions that meet the unmet needs of cancer patients.

Job Summary

We are seeking a highly experienced and skilled Vice President, Drug Product to join our Pharmaceutical Development and Manufacturing team. As a key member of our leadership team, you will be responsible for leading formulation development and drug product manufacturing operations from early to late development through commercialization.

Key Responsibilities

  • Lead cross-functional teams to develop and execute formulation development and drug product manufacturing strategies
  • Oversee the development and execution of functional activities associated with formulation development and drug product manufacturing
  • Author and review CMC sections for global regulatory filings
  • Lead the assessment and identification of potential suppliers for drug product development and manufacturing
  • Travel to CDMOs for vendor assessment and qualification, as well as manufacturing oversight

Requirements

  • PhD in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
  • Substantial experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and organizational leadership
  • Extensive experience in late phase drug product development and commercial launch with global CMC regulatory filings
  • Proven track record of strategic leadership and management with at least 10 years of management experience
  • Demonstrated strong project and cross-functional team leadership, as well as people management skills
  • Thorough understanding and working experience of drug product development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
  • Extensive working experience with management and oversight of manufacturing activities at CDMOs
  • Strong problem-solving skills with strategic and sound technically driven decision-making ability
  • Effective written and verbal communication skills and interpersonal skills