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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 TeamContribute to the technical transfer support activities,Provide process oversight and support,Deviation support and sustainabilityDay-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 confirmationOn 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%).
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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