Director – Analytical Product Research and Development

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

The purpose of the position of Director – Analytical Product Research and Development - at Lilly, Bengaluru is to provide technical and organizational leadership to the GMP analytical, Corporate Reference Standard Organization, Raw Materials/Extractable Leachable, Lab informatics, Power BI and Dashboarding teams and other similar functions that may be formed supporting PRD functions in Indianapolis

The following are the primary responsibilities of the role

• Onboarding and continued training: The role is responsible for setting up the systems for rapid onboarding and appropriate training for the individuals joining the team. The leader is also responsible for tracking the training of the team members and ensuring that experienced individuals continue to stay trained and focus on continuous improvement, where necessary

• Capability tracking and metrics maintenance: The leader is responsible to monitor and track and communicate the utilization of the team using metrics data generated. The leader should also closely interact with key stakeholders in Indianapolis to assess the capability of the individuals to perform the tasks that are assigned to them.

• Project assignments: identifying resources to work on projects depending on the skill and time commitment needed. Proactively work with stakeholders in Indianapolis to manage the book of work

• Conflict resolution and other challenges: The leader is responsible for working with the team members and tracking potential issues and challenges in projects and proactively partner with team members and stakeholders to identify solutions. The leader is responsible for resolution of the issue instead of reliance on stakeholders in Indianapolis to work with team members in Lilly Bengaluru to identify solutions
• Operations: The leader is responsible for maintaining operational excellence for the team and ensuring that the team needs are articulated to leadership. The leader is responsible for gathering requirements during business planning and ensuring that team is adequately resourced to execute the book of work
• Proactive leadership: The leader is responsible for proactively driving the required technical and behavioral change required for effectiveness of the team. This includes technological implementation in partnership with Tech at Lilly and improving/investing in technical transformation of the analytical team to be more capable of handling the diversity of portfolio molecules which will enter development in the future
• Supervising, Coaching and Mentoring: The leader is responsible for direct supervision of individuals and group leaders directly reporting to them. They are responsible for performance management, promotion and other career development discussions in close collaboration with stakeholders in Indianapolis. They should invest time in the development of other supervisors in the team to grow as effective technical leaders. They should actively solicit the help of senior leaders in Indianapolis and Bengaluru to provide coaching and mentoring to their team members
• Spokesperson for the team: Actively network with Indianapolis teams to showcase the capabilities of the functions in Lilly Bengaluru. Identify opportunities for the teams to support the entire PRD organization.
• Leader of the GMP analytical Leads Team: Ensure that the primary responsibilities of the GMP analytical leads (which primarily include (1) Batch Release, 2) Stability Support for Demo & GMP Batches, 3) DUCT Import, 4) MSP Documents, 5) Change Controls) are executed with high level of quality. The leader should actively participate in projects where individuals need guidance on technical or communication aspects and ensure high quality products are delivered on time.
• Leader of the Power Bi Dashboard and informatics team: The leader is responsible for working with stakeholders in Indianapolis and ensuring that proper prioritization of the projects occur. The leader should actively solicit projects from Indianapolis for this function
• Leader of the CRSO organization: Ensure that the CRSO group continues to actively work with the stakeholders in Indianapolis and deliver on projects
• Schedules and leads regular staff meetings, including technical presentations to ensure the staff remains current in awareness of opportunities related to pharmaceutical, packaging and device technology.
• Integrates team members with appropriate functional counterparts/organizations other appropriate PRD organizations to ensure the staff remain current in awareness of issues of pharmaceutical and device development technology and capabilities, regulatory initiatives/requirements, and associated processes for deploying throughout the organization.
• Ensures that the department keeps current with scientific literature/new technology/capabilities and regulatory initiatives/requirements and their implementation, as appropriate.

Minimum Qualification Requirements:

• Formalized training in Biology, Chemistry, Engineering or Pharmaceutical Sciences through the Ph.D. level; with 12+ years of pharmaceutical drug development, pharmaceutical science, or medical device technology experience in an industrial setting. It is preferred to have knowledge in biologics analytical research and development.
• Broad Drug Development experience, exposure to Delivery Device technologies and demonstrated ability of building new CMC capabilities through alliances, building specific new platforms/technologies, experience with CMO diligences/qualification and industry/university collaborations are highly desired.
• Preferred to have experience in leading a diverse drug development team – with mindset of developing high performance team culture. The individual will be responsible for setting coaching frameworks to drive technical independence of the project teams and their deliverables.

Other Information/Additional Preferences:

• Excellent communication, interpersonal, and leadership skills are essential. The individual must have a thorough understanding of GMPs (Good Manufacturing Practices) and the development process to ensure the efficient movement of projects through development to successful product registration.
• Demonstrated ability to motivate large teams of diverse technical personnel to deliver business impact and "leader of leaders" / "team of teams" type leadership experience highly desired.

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Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.