Director - BRD Analytical Development

Responsibilities

• Possess prior experience leading analytical efforts focused on pharmaceutical drug substance and/or drug product development and commercialization, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry.
• Demonstrate a depth of knowledge in concepts relevant to drug substance and drug product commercialization, including developing analytical methods, justifying specifications, designing stability studies, authoring regulatory submissions and addressing questions from global regulatory agencies.
• Drive the implementation of technical solutions and analytical strategies to enable drug substance and drug product process design.
• Collaborate with project teams to deliver robust control strategies for drug substances and drug products and/or intermediates.
• Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
• Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed and fit-for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
• Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas; be able to use these techniques to bring value across a portfolio of peptide, oligonucleotide, monoclonal antibody, gene therapy, and/or bioconjugate modalities.
• Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
• Responsible for introduction of new methodologies for optimization of existing modalities or development of control strategies for new modalities.
• Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
• Collaborate closely with organizations across Discovery, Development, and Manufacturing to execute and deliver material and information for clinical trials and regulatory submissions.
• Embrace diverse thoughts, backgrounds, and experiences to deliver innovative solutions.
• Possess strong communication (oral, written), organizational, and leadership skills.
• Actively engage in the external environment and the ability to recognize and apply external innovation across the Lilly synthetic portfolio.

  Requirements

  • Ph.D. in Analytical Chemistry or Bioanalytical Chemistry, with 5+ years of experience in the pharmaceutical industry after earning degree; or alternatively a B.S. in Chemistry with 15+ years of experience; or M.S. in Chemistry with 10+ years of experience.
  • Prior experience leading analytical efforts focused on pharmaceutical drug substance and/or drug product development and commercialization, as well as demonstrated familiarity with emerging trends in the industry. Introduced new methodologies for optimization of existing modalities or development of control strategies for new modalities.
  • Experience in developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets. Authored IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
  • Experience with management of technical projects. Provided technical guidance for analytical activities executed within the external network. Ensured methods are technically sound, well developed and fit-for-purpose. Executed technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
  • Possesses strong communication (oral, written), organizational, and leadership skills. Demonstrated ability to drive and accept change.
  • Mentored and developed scientific staff. Ensured continued technical and professional growth of group members, encouraged efforts towards excellence and knowledge sharing. Demonstrated leadership capabilities especially in a team environment.