The TS/MS Scientist provides technical supports for assigned API intermediate and API manufacturing processes. They are a member of Internal Process Team (IPT) / Joint Process Team (JPT) and contribute as a liaison between the IPT and contract manufacturing (CM) process team.
Detailed responsibilities include…
· Contributing to the technical transfer support activities.
· Providing technical oversight and stewardship for manufacturing processes.
· Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
· Ensuring that processes are compliant with US and global regulations, capable, in control, and maintained in a validated or qualified state.
· Leading resolution of technical issues, including those related to control strategy and manufacturing.
· Executing technical projects to improve process control, yield, purity, and/or productivity.
· Ensuring processes are executed according to approved process flow document.
· Preparing relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, process flow documents (PFD), validation master plans (VMP), etc.
· Developing and monitoring established metrics in real-time to assess process variability and capability.
· Ensuring that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
· Analyzing data and ensuring appropriate documentation.
· Influencing and implementing the API network technical agenda and driving continuous improvement.
· Building and maintaining relationships with development and central technical organizations.
Basic Requirements:
· BS in STEM discipline (Chemistry/Biochemistry strongly preferred)
· 5+ years of demonstrated experience with cGMP manufacturing
· Or MS or PhD in STEM discipline with 2+ years of demonstrated experience with cGMP manufacturing
· Demonstrated ability to function in a cross-functional team environment and to provide technical leadership
· Demonstrated ability to work independently and to manage/prioritize competing priorities
· Strong written and verbal communications skills with various audiences
· Ability to influence diverse groups and manage relationships
· Willingness to relocate to contract manufacturing site or an estimated 3-year assignment before returning to designated Lilly site
Additional Preferences:
· Knowledge and experience with Regulatory requirements
· Knowledge of data management practices across manufacturing
· Relevant industrial experience in any of the following: API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development
· Demonstrated basic knowledge in small or large molecule API Manufacturing
Additional Information:
· Some international travel (<25%) is required primarily to Indianapolis, Indiana
· Some off-shift work (night/weekend) may be required to support 24/7 operations
