Senior Director of Analytical Development

2 weeks ago


California, United States The Higgins Group, Inc. Full time
About the Role

We are seeking a highly experienced and skilled professional to join our team as Vice President, Analytical Development & QC. As a key member of our Pharmaceutical Development and Manufacturing organization, you will be responsible for leading analytical development and operations in support of clinical development and commercialization of our pipeline compounds.

Key Responsibilities
  • Lead analytical development and operations from early to late development through commercialization
  • Develop and execute analytical related development strategies, overseeing execution of functional activities in support of clinical development, regulatory filings, and product approvals
  • Author and review CMC sections for global regulatory filings
  • Lead cross-functional CMC teams to ensure adequate development and execution of CMC plans and strategies
  • Collaborate with cross-functional teams to ensure CMC and program goals are met
Requirements
  • PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field
  • Substantial experience in pharmaceutical/biotech industry with technical expertise and organizational leadership
  • Extensive experience in late phase innovative drug 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
What We Offer

We offer a dynamic and innovative work environment, competitive compensation and benefits package, and opportunities for professional growth and development.



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