Senior Director - Technical Services/Manufacturing Sciences (TS/MS)

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.

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary:

This individual will serve as the Site Leader for the Technical Service/Manufacturing Science (TS/MS) Department which is focused on the technical aspects of Site manufacturing processes and on defining and executing process improvements based on sound scientific principles driving towards predictable and robust process metrics. This includes leading the effort for the following areas: technical support and technology transfer (internal to Lilly as well as to third party contract manufacturers) for the manufacture of finished drug product, process validation, process controls, compliance, continuous process optimization, CMC regulatory support, manufacturing data analysis and process data management.  The Sr. Director – TS/MS enables operational excellence by establishing strong scientific leadership for the site and establishes processes that are well-designed, in-control and validated for making high quality medicine safely.

Responsibilities:

• Representing Technical Services/Manufacturing Science on the Site Lead Team and other lead teams as appropriate.
• Leading technical support for commercial and clinical manufacturing. This includes finished drug product manufactured at CORE and at contract manufacturers.
• Identifying and troubleshooting manufacturing process problems that arise as part of routine manufacturing.
• Collaborating with CMC to define, implement and improve control strategies for all manufacturing processes at the CORE site.
• Defining business and strategic plan goals and ensuring goals are met.
• Leading critical business decision-making as part of the business and strategic plan including the development of the technical agenda to improve productivity, capacity, and quality of the product.
• Identifying efficiencies and opportunities for continuous improvement across all manufacturing processes, leading to optimum product quality and reduction in cost of goods.
• Managing process validation programs required at the commercial scale. These include but are not limited to:
  • Process consistency
  • Process and product robustness
  • Process automation
  • Scale-up activities
  • Process hold times
• Ensuring all products are manufactured according to a validated process, following the approved control strategy, and maintaining validated status during the product cycle.
• Collaborating with CMC on early-stage clinical validation/robustness studies in support of future commercialization.
• Developing and maintaining trending systems and routine process monitoring, including leading and lagging indicators, per the defined control strategy for evaluating data from manufacturing processes.
• Working with technical teams to evaluate manufacturing process data.
• Providing support to CMC/Regulatory teams through the preparation of required CMC sections of BLAs, INDs, CTDs, CTAs, IMPDs, NDAs and ANDAs as well as additional documentation such as responses to Regulatory Authority questions and annual reports.
• Serving as the liaison between CMC/Regulatory Affairs and Subject Matter Experts on issues related to regulatory filings.
• Providing technical support during regulatory inspections and submissions, as well as partner and internal audits.
• Participating as a team member for Health Authority meetings as required.
• Ensuring cGMP and corporate compliance for the organization.
• Foster a compliant culture by contributing and adhering to safety, environmental, and quality standards. 
• Providing oversight for Technology Transfer plans for the Site.
• Owning key technical documents for the site, including Validation Master Plan and Process Control Strategy.
• Interacting with local and global functional areas and external suppliers/agencies. Influencing, negotiating, and making decisions thr