Opening For Senior Microbiologist Parenteral Manufacturing : Indianapolis

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Amar Annamalai
Amar Annamalai's picture
Opening For Senior Microbiologist Parenteral Manufacturing : Indianapolis

 Company Overview
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees – in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
This position will provide technical and strategic stewardship of sterility assurance programs employed at the Indianapolis Parenteral Manufacturing site. The role involves use of risk-based approaches to define and assess sterility assurance controls for existing processes and new installations as well as implementation of process improvements. Position will lead and integrate activities that drive the highest standard for sterility assurance across multiple functions including Technical Services Process Simulations, Engineering: Facilities/Utilities, Environmental Monitoring, Quality Assurance and Microbiology Quality Laboratories.
• Use of risk-based approaches (i.e. HAACP, FMEA, etc.) to evaluate existing parenteral products manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
• Identification and definition of acceptable aseptic manipulations, and interventions and the associated controls, to be used in manufacturing processes based on risk analysis.
• Execution of a risk-based approach to identify areas of highest risk in support of sampling location selection for Environmental Monitoring Performance Qualification and eventual identification of routine environmental monitoring sampling sites.
• Lead or provide consultation for investigation of sterility assurance-related events and non-conformances.
• Develop/maintain site programs for training and qualification of aseptic personnel.
• Represent/defend site sterility assurance strategies during internal assessments/audits and external regulatory inspections.
• Influences corporate guidance associated with sterility assurance.
• Develop sterility assurance strategies to be employed for new facilities/utilities or processes.
• Detailed knowledge and understanding of cGMPs and global compliance expectations for aseptic processing (e.g. US FDA, EU, etc.)
Basic Qualifications
• PhD or Master’s Degree in Microbiology, Biology or a related scientific field
• Minimum of 10 yrs. of experience in support of parenteral products manufacturing
Additional Skills/Preferences
• Technical leadership skills
• Interpersonal skills including ability to effectively influence others Technical writing and presentation skills
• Ability to prioritize and attention to detail
• Computer skills
Additional Information
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
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