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Drug Product Continuous System Integrator - United States  

Lilly (company)

Posted on : 18 May 2017

Project Description

Drug Product Continuous System Integrator
United States
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 39,000 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.
The Process Design and Development group is responsible for the development of solutions for analytical, formulation, engineering, automation and modeling efforts to support development and scale-up of investigational small molecules to support clinical and toxicology studies through late stage clinical trials. Through application of scientific training and relevant experience, a team of scientists design a process, automated control strategy, online and offline analytical methods, and the automation to develop and transfer to clinical manufacturing and commercialization new drug candidates.

The Drug Product Continuous System Integrator:
  • Contributes to, leads and/or supervises the integration of formulation, process development, modeling, real-time measurement, and /or laboratory measurement integration to enable a rapid development workflow and an automated control strategy of drug product. Typical responsibilities include:
    • Introduce and develop new unit operation / equipment / measurements / models to enable continuous manufacture of drug product processes, measurements, and analyses.
    • Provide leadership in the integration of multiple data streams both in real-time and also with non-real-time data. This includes both spectroscopic and non-spectroscopic methods.
    • Development of the manufacturing processes and automated control strategies for drug product.
    • Provide leadership in laboratory automation to continue the integration.
    • Preparation of the appropriate manufacturing and control portion of the IND/CTX.
    • Tech transfer of manufacturing, measurement, models and automation to support the preparation of the GMP production, control and analytical systems.
    • Preparation or oversight and review of the appropriate manufacturing and controls portion of regulatory submissions.
    • Provides advice and guidance to teams on the development of a commercial development strategy.
    • Writing and timely completion of technical reports and regulatory documents.
    • Demonstrated ability to learn new skills quickly.
  • PhD in a scientific discipline or
  • Master of Science with 10+ years of experience in a technical role or
  • Bachelor of Science with 15+ years of experience in technical role.
  • Preference will be given to candidates who are knowledgeable over a broad range of skills described above rather than deep mastery in any single skill. Pharmaceutical experience is preferred but not a prerequisite.
  • Developed and commercialized new technology or capability
  • Demonstrated ability to develop continuous processes in any related industry.
  • Demonstrated ability to apply fundamental understanding of engineering principles into process dynamics
  • Strong technical skills to supply business value
  • Demonstrated leadership capabilities especially in a team environment
  • Experience with manufacturing / process support
  • Ability to prioritize multiple activities and manage ambiguity
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.