Senior Vice President of Analytical Operations

2 weeks ago

California, United States The Higgins Group, Inc. Full time

COMPANY OVERVIEW

The Higgins Group, Inc. is a pioneering biotech firm focused on the discovery and advancement of innovative therapeutics aimed at addressing critical cancer challenges. Our research is deeply rooted in nature and evolutionary principles, which guide our understanding of cancer targets, disease mechanisms, and treatment methodologies.

To realize our mission, we are committed to exploring groundbreaking therapeutic strategies for some of the most challenging cancers. Our primary focus is on RAS-addicted cancers, which represent a significant portion of new cancer diagnoses. As a member of The Higgins Group, Inc., you will collaborate with exceptional scientists dedicated to the discovery and development of transformative medicines for unmet cancer needs.

POSITION SUMMARY

In this pivotal leadership role within the Pharmaceutical Development and Manufacturing (PDM) division, the Vice President of Analytical Development & QC will oversee analytical development and operations that support the clinical advancement and commercialization of our pipeline compounds. This individual will provide technical, organizational, and strategic guidance, working closely with cross-functional teams to ensure seamless execution of drug development and manufacturing activities in accordance with the integrated development plan and timelines.

Key Responsibilities:

  • Direct analytical development and operations from early-stage through commercialization.
  • Oversee analytical development strategies, ensuring execution of functional activities in support of clinical development, regulatory submissions, product approvals, and market launch.
  • Author, review, and approve relevant CMC sections to facilitate global regulatory submissions.
  • Lead cross-functional CMC teams for assigned projects to ensure effective development and execution of CMC plans and strategies.
  • Act as a core team member, communicating CMC strategies and project statuses to key stakeholders and assisting in decision-making processes.
  • Collaborate with various teams (drug substance, drug product, supply chain, quality, CMC regulatory, clinical, etc.) to meet CMC and program objectives.
  • Identify and assess potential suppliers for analytical development and QC activities, ensuring adequate risk evaluation.
  • Conduct site visits to CDMOs and/or CTLs for vendor assessment and analytical oversight as necessary.

Qualifications:

  • A PhD (or minimum MSc) in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or a closely related field is preferred.
  • Significant experience in the pharmaceutical or biotech industry with a proven track record in technical expertise and organizational leadership, particularly in analytical development for small molecules.
  • Extensive experience in innovative drug development and commercial launch, including global CMC regulatory submissions.
  • Demonstrated strategic leadership and management experience, with at least 10 years in a management role.
  • Strong project and cross-functional team leadership capabilities, along with effective people management skills.
  • Comprehensive understanding of innovative drug development and manufacturing processes, including GMP, quality systems, ICH guidelines, and regulatory requirements.
  • Proven experience managing and overseeing analytical activities at CDMOs and/or CTLs.
  • Exceptional problem-solving skills with a strategic and technically driven decision-making approach.
  • Excellent written and verbal communication skills, complemented by strong interpersonal abilities.
  • A collaborative team player with a high level of energy suited for a dynamic company environment.

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