Vacancy has expired
Show me jobs like this one| Job Ref: | 50428205 |
| Sector: | Business Partner Companies, Other |
| Job Type: | Full Time |
| City: | Indianapolis |
| Post Code: | Aug 31, 2011 |
| Job Description: |
For more than 130 years, Lilly has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicinesinvesting a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a Best in Class Pharmaceutical company, please review the following opportunity: Research Advisor - Bioproduct Analytical Development This Position requires use of controlled technology. An export license from the U.S. Department of Commerce may be required in order to be employed in this position. The Research Advisor will be responsible for leading teams of Analytical scientists in the development and optimization of analytical methods and control strategies for recombinant therapeutic proteins produced in mammalian cell culture and synthetic/pegylated peptides in late-phase clinical development. He/she will interface with internal and third-party labs to lead method optimization, qualification/validation and transfer activities to support clinical and commercial product in-process, lot release and stability testing. In addition, he/she will lead efforts to prepare Analytical sections of Regulatory submissions to support late-phase clinical trials and US/OUS marketing authorizations. KEY OBJECTIVES/DELIVERABLES: Work with cross-functional Development/Medical/Toxicology teams to perform risk assessments for the assignment of preliminary and final bioproduct molecule critical quality attributes (CQAs). Lead analytical method and control strategy development/optimization for therapeutic recombinant proteins and synthetic/pegylated peptides based on CQA assessments. Lead the development and implementation of drug substance and drug product release testing and stability strategies to support therapeutic bioproduct clinical trials and product registration. Collaborate with cell culture, purification and formulation development scientists and manufacturing areas/quality control laboratories to define in-process testing strategies to support clinical and commercial manufacturing of drug substance and drug product. Manage the qualification/validation of bioproduct analytical methods in internal and third-party laboratories. Manage the transfer of analytical methods to Lilly and third-party clinical and commercial testing laboratories in the US and OUS. Author analytical sections of clinical trial applications and marketing applications. Lead a group of analytical scientists supporting bioproduct analytical development; provide coaching, training, and administration of performance management to personnel (primarily, but not limited to, direct reports). Responsible for leading/supporting organizational strategic initiatives, evaluating and/or installing new capabilities/technologies and leveraging internal and external influence to solve problems and benchmark potential solutions. Ensure work and team activities are aligned with all relevant development quality, regulatory, Heath/Safety/Environmental, GLP, and GMP requirements. Requirements MINIMUM REQUIREMENTS: |
| Post Date: | 09/01/2011 |
