Sterility Assurance Scientist

Job Listing No: 9740000

Sterility Assurance Scientist

?Company Overview:Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 6,500 employees in more than 70 countries. Founded in 1954, Elanco is a division of Eli Lilly and Company.?Responsibilities:General:This position is a Sterility Assurance Technology TS/MS (Technical Services / Manufacturing Science) Scientist at the Augusta, Georgia Technology Center that directly supports API and Parenteral drug product manufacturing operations of on the production floor. ?The SAT TS/MS Scientist provides technical support to achieve the reliable and compliant manufacture of parenteral drug product to predetermined global quality standards via a detailed set of manufacturing instructions and procedures.??Position Brand DescriptionSterility assurance lead across the API and Parenteral aseptic processing as it relates to drug product manufacturing.??Define, provide and lead sterility assurance initiatives for the site for continuous improvements. Manage and support execution of routine activities for SAT (Media Fills, EMPQs, data monitoring, etc.) ?Key position responsibility is to address and document GMP compliance issues in validation of the site's sterility assurance plan. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards for validation. Influence and implement technical agenda activities within a multi-discipline technical environment. Work with peer's and leadership in a positive fashion to deliver on functional technical objectives, specific product business plan and quality objectives.?Key Objectives/Deliverables:Technical process support service for parenteral manufacturingDrive the sterility assurance continuous improvement agenda for a reliable parenteral manufacturing siteDrive development of site personnel as it relates to good aseptic techniques and general parenteral requirementsPartner within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives and GMP Quality plan objectives.Review of technical documents, inclusive of but not limited to: Engineering studies, deviation investigations, change controls, non-routine test requests, sterilization validations, technical summary reports, batch records, cleaning validation, sterilization validation, Media Fills, EMPQs, etc.Understand the scientific principles required for manufacturing an API and parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.Continuous improvement towards assurance that an accurate instruction set defined within batch production records, procedures, and Process Flow Documents (PFDs) describe the process as performed and the control strategy for the discrete manufacturing steps.Coach and mentor individuals at the site on SAT initiatives / improvements, etc. to develop technical depth skills, support routine daily operations and improve the technical robustness at the site for Parenteral Pharmaceutical requirementsProvides sterility assurance training for individuals across the siteBasic Qualifications:?? ?BS Degree in Microbiology, Biology or related scientific field10+ years experience supporting parenteral pharmaceutical or parenteral animal health manufacturingPrevious experience leading SAT initiatives across a Parenteral manufacturing siteQualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment positionAdditional Skills/Preferences:?? ?Demonstrated leadership of cross-functional teams and/or demonstrated project management skills.Strong interpersonal and teamwork skills, oral and written communication skillsProblem solving and independent decision making skillsAbility to influence diverse groups and communication skillsMS in science related field (e.g. chemistry, biology, microbiology or related scientific field).Teamwork and interpersonal skills, computer skills, decision making and multi-taskingAdditional Information:?? ?Position supports a 24/7 operation so some night and weekend support will be required?Some travel may be requiredRequired to carry a cell phoneLilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.?Removal Date:?08-Dec-2016

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