Senior Scientist – TS/MS, API EM
2 days ago
We are seeking a highly skilled Senior Scientist to join our team at Lilly Centre for Clinical Pharmacology PTE. LTD. as a Technical Lead – API Manufacturing. The successful candidate will be responsible for providing technical support for assigned API intermediate and API manufacturing processes.
Key Responsibilities- Contribute to the technical transfer support activities.
- Provide technical oversight and stewardship for manufacturing processes.
- Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
- Ensure that processes are compliant with US and global regulations, capable, in control, and maintained in a validated or qualified state.
- Lead resolution of technical issues, including those related to control strategy and manufacturing.
- Execute technical projects to improve process control, yield, purity, and/or productivity.
- Ensure processes are executed according to approved process flow document.
- Prepare 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.
- Develop and monitor established metrics in real-time to assess process variability and capability.
- Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
- Analyze data and ensure appropriate documentation.
- Influence and implement the API network technical agenda and driving continuous improvement.
- Build and maintain relationships with development and central technical organizations.
- 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
- 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
- Some international travel (
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