Sr. Director, Drug Product, SMDD

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:

Synthetic Molecule Design and Development (SMDD) is comprised of different groups that design and execute the development of all CMC aspects of synthetic molecules from pre-clinical phases through commercialization for drug substances and drug products.

Responsibilities:

Through scientific training and relevant experience, a team of scientists and team leaders support the portfolio from pre-clinical development through the commercialization of new drug candidates.  Teams of cross functional scientists will drive integration of technical elements from internal and external groups enabling the clinical manufacturing and commercialization of new drug candidates.

• Understands and complies with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and provides leadership in the establishment and maintenance of SMDD Quality systems.

• Contributes to, leads and/or supervises the formulation, process development and or control strategy of drug product.  Typical responsibilities include:

  • Designs and develops the quality target profile for assets entering clinical development

  • Development of the manufacturing processes and control strategies for drug product.

  • Development of the manufacturing processes and control strategies for drug product leading to FHD.

  • Preparation of the appropriate manufacturing and controls portion of the IND/CTX and preparation of information for annual updates.

  • Scale-up and transfer of processes to manufacturing.

  • Preparation or oversight and review of the appropriate manufacturing and controls portion of regulatory submissions.

  • Provides advice and guidance to teams on the development of a clinical and commercial development strategy.

  • Authors, reviews, or approves high quality technical reports and regulatory submissions dealing with the work performed by the department.  Ensures that records and technical notebooks are adequately maintained.

  • Oversight of drug product material supply campaigns internally or in the third party network.

• Demonstrates the TeamLilly Leadership behaviors

• Plans and manages short term and long-term development activities.  Assigns work to be done, coordinates, evaluates, and reviews the activities of personnel assigned to the group.

• Develops or reviews plans and timetables for project work.  Recommends the resource allocation to accomplish projects according to plans, communicates progress, and proposes changes in project timetables, objectives, or direction.

• Authors, reviews, or approves high quality technical reports and regulatory submissions dealing with the work performed by the department.  Ensures that records and technical notebooks are adequately maintained.

• Helps ensure that people, and their environment are safe and that company policies concerning safety are followed.

• Collaborates closely with business interfaces including Discovery Chemistry, Biology, ADME, Toxicology, Product Delivery, Quality, Manufacturing and Regulatory.

• Takes leadership in the supervision of the compliance of this department with the laws, regulations, guidelines, procedures, and practices governing drug research and development, including the departmental and corporate standard operating, good manufacturing, and safety procedures.

• Enhances Lilly’s professional image and competitive advantage by patents, presentations, publications, and professional activities.

• Reads current literature and appraises relevant new technologies and products.  Ensures that people assigned to their group continue to grow technically and professionally and encourages their efforts toward excellence.  Encourages them to share learnings by word and example.

• Supervision, mentorship and technical development of the scientific staff.

• Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately.

Basic Requirements

• PhD in engineering or pharmaceutical science or related fields wit