B135 API Pilot Plant Scientist

Eli Lilly and CompanyIndianapolis, IN
Onsite

About The Position

Provides technical support for manufacturing API intermediates and bulk drug substances. Key Objectives/Deliverables: Provide support for GMP manufacturing of intermediates and bulk drug substances to supply clinical trials, utilizing peptide synthesis and purification platforms. Work with collaboration partners to complete transfer processes into the Pilot Plant utilizing quality systems. Understand the scientific principles required for scale-up and development of manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment. Provide technical support to non-routine investigations including evaluating materials from production in the development model. Participate in development and implementation of process improvements, including capital expansions and technical projects. Work within cross-functional teams in a positive fashion to implement TS/MS objectives. Interact with process teams to identify improvement and productivity objectives and drive technical innovation within area of responsibility. Teach and mentor other scientists and specialists in area.

Requirements

  • High-quality skills to include: Teamwork and interpersonal, technical knowledge, decision making, multi-tasking, ability to influence groups, communication skills, computer skills, statistical analysis, and problem solving
  • Must complete Learning Plan for Scientist – TS/MS Pilot Plant
  • Tasks require entering manufacturing areas which require wearing appropriate PPE

Nice To Haves

  • Experience with owning change controls and deviation investigations
  • Relevant industrial experience in any of the following associated disciplines such as Protein Manufacturing, Development, and Quality Control is desirable

Responsibilities

  • Provide support for GMP manufacturing of intermediates and bulk drug substances to supply clinical trials, utilizing peptide synthesis and purification platforms
  • Work with collaboration partners to complete transfer processes into the Pilot Plant utilizing quality systems
  • Understand the scientific principles required for scale-up and development of manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment
  • Provide technical support to non-routine investigations including evaluating materials from production in the development model
  • Participate in development and implementation of process improvements, including capital expansions and technical projects
  • Work within cross-functional teams in a positive fashion to implement TS/MS objectives
  • Interact with process teams to identify improvement and productivity objectives and drive technical innovation within area of responsibility
  • Teach and mentor other scientists and specialists in area

Benefits

  • company bonus (depending, in part, on company and individual performance)
  • company-sponsored 401(k)
  • pension
  • vacation benefits
  • medical, dental, vision and prescription drug benefits
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • life insurance and death benefits
  • certain time off and leave of absence benefits
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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