Manufacturing Scientist – Manufacturing Process Support
Eli Lilly
- Vernier, Genf
- Unbefristet
- Vollzeit
- PIP site support activities:
- Active member of Joint Process Team
- Contribute to the technical transfer support activities,
- Provide process oversight and support,
- Deviation support and sustainability
- Day-to-day production supports (such as, rig walk-throughs, on the floor daily presence, QA & HSE walkthroughs, ensure practice match procedure, Fit finish and housekeeping walkthroughs),
- CAPA implementation confirmation
- On site support (liaison between production floor and APIEM process team)
- Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
- Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
- Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
- Develop and monitor established metrics in real-time to assess process variability and capability.
- Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
- Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
- Provide support internal and joint process teams and to the global and local PLOT teams.
- Ability to independently set up and execute various chemical reactions.
- Ensure that experiments are well designed with clear objectives
- Ability to analyze data and ensure appropriate documentation
- Utilize save laboratory practice and adhere to CHP requirements
- Write technical reports and documents
- Bachelors in STEM Discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing.
- Master's Degree and 1 year experience in cGMP manufacturing.
- Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development.
- Demonstrated basic knowledge in small or large molecule API Manufacturing.
- Familiarity with cGMP manufacturing environment and terminology.
- Excellent analytical, interpersonal, written and oral communication skills.
- Ability to work independently as well as part of a team.
- Ability to prioritize activities.
- Good judgment and flexibility.
- Tasks require entering manufacturing areas which require wearing appropriate PPE.
- Domestic and international Travel (variable, can approach 20%).