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 c GMP 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 through those interactions.
• Building relationships externally to Lilly to create benchmark opportunities and identifying best practices.
• Driving cross functional alignment with other teams and external partners.
• Leading, developing, coaching and mentoring an organization of scientists and technical resources with the intent of developing future leaders.
• Ensuring the development of technical depth within the Site.
• Ensuring effective hiring and staffing (right person for the right role).

Basic Requirements:

• Ph D or MS degree in the scientific disciplines of Chemistry, Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Biochemical or Chemical Engineering.
• Minimum of 10 years’ experience in GMP drug product pharmaceutical manufacturing including commercialization of new products.
• Broad functional expertise and knowledge of manufacturing, industry practices and applicable standards and regulations.

Additional Preferences:

• Thorough understanding of GMP requirements for biopharmaceutical manufacturing.
• Previous experience in leading interdisciplinary technical initiatives.
• Excellent communication skills, both oral and written.
• Must be able to make decisions and communicate effectively (clearly and accurately) with staff and upper management.
• Must be able to mentor/coach staff as well as lead staff with a high level of honesty and integrity.
• Must have a thorough theoretical understanding and technical proficiency of all operations supervised. Must be able to apply technical and operational experience to solve complex problems.
• Must exhibit a teamwork attitude.
• Must have strong leadership and organizational skills.
• Experience in Operational Excellence Programs.
• Functional expertise and knowledge of radiopharmaceutical industry practices and applicable quality / technical standards and regulations.
• Experience in supporting the successful commercialization of biopharmaceutical manufacturing processes and/or commercial facilities, audit participation and direct interaction with regulatory authorities preferred.
• Radiopharmaceutical expertise preferred.

Additional Information:
Physical Demands/Travel:
The physical demands of this job are consistent with a manufacturing environment. Shift is days, but off-hours may be necessary to support operations. Up to 10% travel is possible.
lab environment.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position’s work environment is an onsite, manufacturing environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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