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**Global Technical Services Molecule Steward

2 months ago

Marquand, Missouri, United States INFINITE BLU POOL SERVICES LLC Full time
About the Role

We are seeking a highly skilled and experienced professional to join our team as a Global Technical Services Molecule Steward - Dry Products Lead. This role will provide technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network.

Key Responsibilities
  • Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed.
  • Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles.
  • Ensure that experiments and technical work are well designed and appropriately rigorous.
  • Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies.
  • Leverage prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing.
  • Author technical reports and appropriate sections of regulatory submission and responses as needed.
  • Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed.
  • Remain current on external pharmaceutical manufacturing trends and innovations.
  • Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation.
  • Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors.
Requirements
  • Bachelor's Degree or higher in Chemistry, Engineering, Pharmacy, or related science.
  • Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing.
About Us

Infinite Blu Pool Services LLC is a leading provider of innovative solutions for the pharmaceutical industry. We are committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs.