Manufacturing Scientist – Manufacturing Process Support, Vernier

Vor 5 Tagen

Vernier, Schweiz TN Switzerland Vollzeit

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Manufacturing Scientist – Manufacturing Process Support, Vernier

Client: Lilly

Location: Visp, Switzerland

Job Category: Other

Job Reference: 1e948e3a8a00

Job Views: 12

Posted: 21.01.2025

Expiry Date: 07.03.2025

Job Description:

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 Scientist provides technical support and oversees the CM facility operations, contributing 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 support (such as rig walk-throughs, QA & HSE walkthroughs), CAPA implementation confirmation, on-site support (liaison between production floor and API EM process team).
  • Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of 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, such as technical reports, change controls, regulatory submissions, deviation investigations, validation protocols, and summary reports.
  • 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.
  • 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 to 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 safe laboratory practices and adhere to CHP requirements.
  • Write technical reports and documents.

Basic Requirements:

  • Bachelor's 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 API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
  • Demonstrated 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.

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