Deborah Ruth's Location
Denver Metropolitan Area, United States, United States
Deborah Ruth's Contact Details
Deborah Ruth work email
- Valid
- Valid
- Valid
- Valid
Deborah Ruth personal email
n/a
About Deborah Ruth
Deborah Ruth is a Senior Manager, Analytical Outsourcing at Gilead Sciences. She possess expertise in validation, gmp, analytical chemistry, pharmaceutical industry, sop and 29 more skills.
Deborah Ruth's Current Company Details
Deborah Ruth Work Experience Details
-
Senior Manager, Analytical OutsourcingGilead Sciences May 2022 - PresentFoster City, Ca, Us-Manage outsourced analytical testing for biologics including, raw materials, in-process, release, stability, analytical method validation and transfer.-Develop strategy for management of outsourced testing and manufacturing needs, considering timelines, risk mitigations and business priorities.-Ensure on time deliverables, including release and stability data, method transfer and validation studies.-Plan and approve proposals, work orders and changes in scope.-Coordinates with legal and QA to establish confidentiality/nondisclosure agreements, service terms and conditions and quality agreements.-Develop effective strategies for the evaluation, selection and transfer of new projects to contract organizations.-Coordinate testing schedule for Biologics based on program requirements by interfacing with AnalyticalOperations, Chemical Development and Formulation/Process Development.-Participate in Quality audits and regulatory inspections.-Develop, execute and ensure compliance to procedures for outsourced testing.
-
Senior Manager Biochemistry, Quality ControlAgc Biologics Aug 2021 - Apr 2022Bothell, Wa, UsProvided leadership for GMP analytical testing for clinical and commercial products. Managed method validation, transfer activities and specification setting associated with QC testing of GMP products.-Managed all daily activities within the QC biochemistry labs ensuring the efficiency and effectivenessrelated to raw materials, in-process, release, stability, analytical method validation and transfer.-Assisted in the design, implementation and continuous improvement of QC systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.-Managed laboratory investigations, deviations, CAPA and change controls through QMS.-Ensured on time QC deliverables, including release and stability data, method transfer and validation studies.-Represented QC on cross-functional teams for both internal and external clients.-Hired, mentored and developed QC personnel.-Led activities related to analytical equipment implementation, qualification, validation, calibration and maintenance.-Planned and approved all capital expenditures.-Developed and created a workable floor plan for all biochemistry lab space equipment and utilities.-Represented QC GMP operations during audits and regulatory inspections.-Ensured QC laboratories were audit and inspection ready at all times. -
Quality Control ManagerNovartis Gene Therapies Aug 2019 - Jul 2021Basel, Baselstadt, ChOversaw the supervision and management of all functions within the Quality Control labs from start-up to establishment.-Managed daily laboratory operations for all analytical testing including, raw materials, in-process, DS/DP, and stability while ensuring product quality, cGMP compliance and application of LEAN principles.-Provided leadership to team of 18 comprised of Supervisors, Specialists and other technical staff.-Created and led updates to technical reports, methods, procedures and other quality documents.-Managed activities for all QC Analytical tech/method transfers, validation, and verifications.-Coordinated and led all laboratory investigations, deviations, CAPA items and change controls through QMS.-Maintained a safe working environment for all essential laboratory personnel during COVID-19.-Supported the hiring, training, and development of all QC staff to create a culture of accountability, teamwork, cordiality and respect.-Created clear and accurate department resource models and KPIs.-Implemented new laboratory technologies/equipment including knowledge of qualification, maintenance and calibration activities.-Provided concise communications with supply chain, manufacturing and other global site departments in order to align priorities and organizational objectives.-Worked closely with the regulatory team to provide analytical documentation to the FDA and international regulatory agencies during regulatory submissions.-Led audit tour activities and acted as department SME. -
Supervisor Analytical Development And QcTolmar Mar 2017 - Jul 2019Fort Collins, Co, UsManaged team of 29 comprised of Supervisors, Analysts, and other technical support staff at two separate facilities.-Managed testing and on time release of pharmaceutical products, raw materials, intermediates, cleaning, bulk and stability samples for clinical and commercial products.-Led cGMP/GDP compliance within QC and performed all data integrity training to QC staff.-Created and executed laboratory strategic plan to increase process efficiency.-Provided evaluation of the overall validity of the analytical results reported, generated certificate of analysis and reviewed/approved stability reports.-Conducted and coordinated laboratory investigations, deviations and incident reports, planned and executed CAPA items and change controls through QMS.-Lead project teams, laboratory site inspections, third party audits, and regulatory audits.-Determined prioritization of method validation/transfer projects and workflow to ensure on-time delivery of results.-Authored and updated protocols, technical reports, product methods, company and departmental SOPs.-Managed an intermediate technical team to transfer all analytical methods from Analytical Development into QC.-Provided expert technical knowledge on equipment, analytical testing, formulations, method validation, transfer, and process remediation for aseptic manufacturing.-Led team on interpersonal and organizational skills to increase laboratory throughput. -
Lead ScientistSandoz Jun 2012 - Nov 2016Basel, Basel-Stadt, ChDirected company-wide automation project in quality control laboratory as SME.-Served as project lead on installation, qualification and validation of automated systems working collaboratively with vendor, engineering, manufacturing, security and outside contractors.-Created, implemented and executed written documents including SOP’s, change controls, forms, protocols and reports adhering to cGMP good documentation practice.-Developed training program for QC team to operate and troubleshoot all automated laboratory equipment.-Supervised and scheduled activities for a team of 15 QC chemists in relation to in-process, finished product, stability and cleaning validation testing. -
Analytical Development ScientistSandoz Jan 2011 - Jun 2012Basel, Basel-Stadt, Ch-Executed analytical testing related to process validations, engineering/notebook studies, product reformulations, process optimizations, and laboratory investigations.-Analyzed complex data sets, summarized results and performed risk analysis as well as corrective actions.-Utilized technical concepts required for method development and validation per USP guidelines.-Collaborated with regulatory affairs on new filings and provided status updates.-Managed ongoing projects in team environment in order to meet site goals and deadlines.-Managed all DEA activities within the laboratory including training.
-
Laboratory Assistant/Histology TechnicianBoulder Community Hospital Jul 2010 - Oct 2011Boulder, Co, Us -
Qc Chemist IiiGeneva Pharmaceuticals Jun 1997 - Feb 2001
Deborah Ruth Skills
Validation
Gmp
Analytical Chemistry
Pharmaceutical Industry
Sop
Chromatography
Hplc
Glp
Quality Control
Laboratory
Fda
Lims
Biotechnology
Pharmaceutics
Life Sciences
Regulatory Affairs
Capa
Analytical Method Validation
Laboratory Automation
Technology Transfer
Laboratory Skills
Laboratory Instrument Control/software Interface Validation
Operational Qualification
Chromatography Data System Validation
Team Leadership
Equipment Qualification
Process Qualification
Standard Operating Procedure
Supervisory Skills
Organizational Leadership
Collaborative Leadership
Team Management
Cross Functional Team Building
Management
Deborah Ruth Education Details
-
Metropolitan State University Of DenverChemistry -
Metropolitan State University Of DenverBiology/Biological Sciences
Frequently Asked Questions about Deborah Ruth
What company does Deborah Ruth work for?
Deborah Ruth works for Gilead Sciences
What is Deborah Ruth's role at the current company?
Deborah Ruth's current role is Senior Manager, Analytical Outsourcing.
What is Deborah Ruth's email address?
Deborah Ruth's email address is de****@****doz.com
What schools did Deborah Ruth attend?
Deborah Ruth attended Metropolitan State University Of Denver, Metropolitan State University Of Denver.
What skills is Deborah Ruth known for?
Deborah Ruth has skills like Validation, Gmp, Analytical Chemistry, Pharmaceutical Industry, Sop, Chromatography, Hplc, Glp, Quality Control, Laboratory, Fda, Lims.
Who are Deborah Ruth's colleagues?
Deborah Ruth's colleagues are Konrad F. Noronha, Candy Tu, Robin Pancheri, Ashley Ferraro, Amjad M. S., Jennifer Chan, Jaimon J..
Free Chrome Extension
Find emails, phones & company data instantly
Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Aero Online
Your AI prospecting assistant
Select data to include:
Total price:
$0.00
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial