Manufacturing Scientist – Manufacturing Process Support
Publication date:
19 March 2024Workload:
100%Contract type:
Unlimited employment- Place of work:Vernier
Manufacturing Scientist – Manufacturing Process Support
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.
Organization Overview:
The Active Pharmaceutical Ingredient - External Manufacturing Organization (API EM) TS/MS Person-in-Plant (PIP) Scientist provides the technical support required to achieve the reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio which includes raw materials, intermediates, and bulk drug substances. The PIP (Person-in-Plant) scientist position is a remote role, located in Visp, Switzerland. The PIP Scientist provides technical support and oversees the CM facility operations. The PIP scientist is a member of IPT/JPT and contribute as a liaison between the IPT and CM process team.
Responsibilities:
- 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
Basic Requirements:
- Bachelors in STEM Discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing.
or
- Master's Degree and 1 year experience in cGMP manufacturing.
Additional Preferences:
- 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.
Additional Information:
- Tasks require entering manufacturing areas which require wearing appropriate PPE.
- Domestic and international Travel (variable, can approach 20%).
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