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Principal - Process Sciences Associate - United States  

Lilly (company)


Posted on : 12 June 2017

Project Description

Company Overview  
  • We unite caring with discovery to make life better for people around the world. 
  • 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.

  • This position is responsible for the technical support of manufacturing operations. 
  • This position will interact with the engineering, manufacturing, validation, quality assurance, quality control and regulatory departments. 
  • Interaction may be required with other site / contract producers of  products. 
  • Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is required. 
  • Spreadsheet experience is required.  Database experience a plus.
  • Responsible for supporting manufacturing operations through the performance of the following duties and representing TS/MS on Manufacturing Process Teams:
  • Monitors (trends) and analyzes production data.  
  • Applies process knowledge and data analysis skills to support the management of daily manufacturing operations. 
  •  Presents process data and analyses in Manufacturing Process Team meetings
  • Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor.  
  • Communicates issues in a timely manner.  Leads process-related investigations and assesses technical impact
  • Assists in the transfer of processes from process development to production facilities and from one production facility to another, anticipating and addressing scale-up issuesAuthors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies
  • Writes standard operating procedures as they relate to the activities of the TS/MS group.  
  • Reviews and approves manufacturing batch records and other manufacturing documentation
  • Works directly with the Manufacturing staff on the manufacturing floor to share process knowledge.  
  • Assists in process-related training of Manufacturing Process Team members.  
  • As required, directly gathers additional supporting data on the manufacturing floor
  • As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories.  Helps to define and implement continuous improvements to manufacturing processes
  • Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment. 
  •  Helps to define and implement control strategies for company Branch burg processes
  • As required, may lead or assist in the planning and execution of process validation activities
  • As required, may own or assist in the implementation of process-related change controls
  • Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP 

Basic Qualifications
  •  BS degree in Chemistry, Microbiology, Biochemistry or related science, or BS in Chemical Engineering or related engineering discipline
  • Minimum of 3 years experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment
  • Qualified candidates must be legally authorized to be employed in the United States. 
  • Our company does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position  

 Additional Skills/Preferences  
  •  Experience in fermentation/cell culture and/or protein purification manufacturing
  • Process and equipment knowledge of cell culture or purification functions
  • Thorough understanding of GMP requirements for a large scale manufacturing facility
  • Process validation experience a plus
  • Demonstrated leadership skills
  • Excellent communication skills, both oral and written