Shiela Smith Email and Phone Number
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Extensive experience in the Biotech/Pharmaceutical industry within quality and technical services organization. Successful efforts in introducing and implementing process improvements that resulted in gained efficiency, higher outputs and company savings. Proven successful in leading cross-functional teams and driving to achieve program milestones.
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Associate Director, Joint Process Team, Api External ManufacturingEli Lilly And Company Jul 2024 - PresentUnited StatesLeads cross-functional teams comprised of Lilly and API Contract Manufacturer representatives, builds and maintains a strong and healthy relationship at all levels with CM organizations to ensure timely delivery of projects and materials. -
Senior Principal ScientistEli Lilly And Company Jun 2023 - Jul 2024United States
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Associate DirectorEli Lilly And Company Mar 2022 - Jun 2023Indianapolis, Indiana, United States
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Consultant - Clinical Trials, Commercialization Ts/MsEli Lilly And Company Feb 2017 - Mar 2022Indianapolis, IndianaBuilding and maintaining relationship with the Development organization, leading the cross-functional team and operational performance as it relates to clinical trial supply.
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Validation Manager, Technical ServicesKremers Urban Pharmaceuticals Inc. Feb 2016 - Feb 2017Seymour, In-Main responsibilities include management of the Seymour site validation program, including process, cleaning and packaging. Oversight and coordination of validation-related activities. -Successfully developed and implemented various process improvements associated with process, cleaning and packaging-Continuing to analyze current processes for potential compliance gaps, areas of improvements and streamlining efforts. -
Validation Manager, Quality AssuranceKremers Urban Pharmaceuticals Inc. Oct 2012 - Feb 2016Seymour, In-Provided QA oversight of the validation program, including ownership and maintenance of the validation program related to process, cleaning, equipment, facility, packaging, analytical methods, and computer-related systems. Initiated and managed program improvement initiatives throughout the different disciplines of validation.-Successfully implemented major program improvements in Cleaning Validation Program-Provided guidance to staff regarding validation philosophies (including QbD), field execution and write up. Collaborated with cross-functional groups regarding validation strategies and activities.-Provided QA support and oversight over the R&D facility, involving clinical product release, process support, and equipment and cleaning validation. -Responsible for presenting validation-related topics during audit/inspection. Performed internal audit as requested.-Responsible for staff development
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Sr. Validation Engineer/ Qa ValidationAmgen Dec 1999 - Oct 2012- Served as the QA Validation SME for B20 Fill Facility. Responsibilities included QA oversight of all validation, verification & related activities associated with GMP critical equipment/system for B20. Provided guidance to cross-functional groups regarding validation policies and philosophies, field execution and write up. - Managed facility/equipment related issues, including EM topics. QA contact and Owner for change control and nonconformances associated with validation activities. - Provided QA on-the-floor support during production, including batch record review/approval for the Vial, Syringe and Lyophlization processes.- Provided QA Validation support to other sites for alignment in validation philosophies -
Validation ConsultantValidation Technologies Inc. Jan 1998 - Dec 1999Execute validation studies, including report write-ups
Shiela Smith Skills
Shiela Smith Education Details
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Biochemistry
Frequently Asked Questions about Shiela Smith
What company does Shiela Smith work for?
Shiela Smith works for Eli Lilly And Company
What is Shiela Smith's role at the current company?
Shiela Smith's current role is Associate Director, Joint Process Team, API External Manufacturing, Lilly.
What is Shiela Smith's email address?
Shiela Smith's email address is sp****@****gen.com
What is Shiela Smith's direct phone number?
Shiela Smith's direct phone number is +180544*****
What schools did Shiela Smith attend?
Shiela Smith attended University Of California, Los Angeles.
What are some of Shiela Smith's interests?
Shiela Smith has interest in Football, Exercise, Sweepstakes, Nascar, Home Improvement, Reading, Sports, Watching Basketball, Golf, Home Decoration.
What skills is Shiela Smith known for?
Shiela Smith has skills like 21 Cfr Part 11, Gamp, Gmp, Computer System Validation, Biopharmaceuticals, Biotechnology, Cip, Fda, Cleaning Validation, Sterilization, Sip, Lyophilization.
Who are Shiela Smith's colleagues?
Shiela Smith's colleagues are Kyle Sullivan, Peter Hagerstrom, Eduardo D., Adam Hoye, Venkata Gopalakrishna Thammanaboina, Gregory Thompson, Harry Zhang.
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