Director - BRD Analytical Development

About the role

The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. Scientists have full access to Lilly’s deep pharmaceutical development expertise and engineering capabilities.

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.
• Drive the implementation of technical solutions and analytical strategies to enable drug substance and drug product process design.
• 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.

Qualifications

• Strong technical skills to enable innovation which creates business value.
• Creativity and ability to transform ideas into marketable products and processes.
• Demonstrated success in persuasion, influence, and negotiation.
• Good interpersonal skills and a sustained tendency for collaboration.
• Ability to prioritize multiple activities and manage ambiguity.
• Ability to influence others to promote a positive work environment.
• Demonstrated technical proficiency and ability to create ideas for future work plans.