Vikki Smith Email & Phone Number

Nutley, Nj, Us

Responsible for quality oversight and leadership in a biologics manufacturing facility for clinical and commercial products. Direct management of teams to maintain QMS. Accountable to continually evaluate current policies, procedures and practices to develop and implement continuous improvement while driving regulatory standards and compliance.

Nutley, Nj, Us

Responsible for quality oversight and leadership in a biologics manufacturing facility for clinical and commercial products. Direct management of teams to maintain QMS. Accountable to continually evaluate current policies, procedures and practices to develop and implement continuous improvement while driving regulatory standards and compliance.

Brentford, Middlesex, Gb

Accountable for a team involved in overseeing all quality aspects for batch release, deviation management and quality record management as well as general quality oversight for the several biopharm assets at various lifecycle stages within manufacturing operations of CMOs.Key Highlights:-Coach and lead a team accountable for all quality aspects of for the R&D biopharmaceutical portfolio. Manage KPIs related to business process improvement across the supply chain for various products.-Manage relationships and supply chain with key stake holders and CMO groups across the globe.-Functioned as the Quality Workstream and PAI readiness lead for a COVID-focused clinical product moving to the commercial market. Key purpose is to perform quality assurance activities and oversight of the GMP functions within a Pharma R&D group. Develop and implement strategy, policy and group objectives that fundamentally raise the importance of quality/compliance within a biopharmaceutical manufacturing environment. Manage work across a CMO drug substance manufacturing facility and CMO testing laboratory to fulfill supply chain needs.

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

Manage, develop and provide leadership to staff executing analytical testing, stability testing, and analytical instrumentation in the areas of microbiology, molecular biology, protein chemistry, small molecular chemistry and immunochemistry for in process and bulk drug substance.Accountable for planning and execution of QC testing to ensure agreed upon cycle time are met, results and data are accurate, valid, and complete and operations are continuously improved through the use of operation excellence and performance management to increase productivity and reduce quality risks.Accountable for the development, validation, and approval of all microbiology, chemistry, biochemistry, stability, and raw materials test methods used in Biopharmaceutical production operations. Responsible for assay technology transfer between R&D and external customers to GMS.Responsible for maintaining current Good Manufacturing Practices and adhering to current FDA Guidelines, ICH, and foreign regulations in the areas of microbiology, biochemistry, chemistry, methods, validation and stability. Responsible for interacting with the FDA and other regulatory agencies, worldwide regarding any questions relating to microbiology, biochemistry, chemistry and stability testing.Responsible for ensuring microbiology, chemistry and biochemistry support to the manufacturing, validation, facility and maintenance departments within Biopharmaceuticals Operations. Responsible for developing and working within capital, S&E, service contracts, overtime, and population budgets. Responsible for ensuring appropriate training is planned, executed, and documented for QC staff as well as annual reviews. Review, monitoring and trending of biochemical, microbiological, environmental, and utility data to ensure a state of control

Brentford, Middlesex, Gb

Aseptic microbiology experience at a vaccine facility.

Luxembourg, Luxembourg, Lu

Provide leadership to 13 people in a contract food testing laboratory for the Microbiology Department.Oversee daily laboratory operations as well as provide support for issues from sample log in through to issuance of reports.Author Microbiology SOPs and QA SOPs in accordance with ISO 17025 guidelines at the Hanover, Maryland location.Design and deliver presentations for business unit managers. Rapidly implemented a new customizable LIMS.Visit clients for various issues as well as for new client sales and environmental monitoring programs.Interact with clients daily to provide information pertaining to regulatory requirements, results and troubleshooting.Participate in client audits.Attend tradeshows and solicit new laboratory business.

Lawrence Township, Nj, Us

Provided leadership to 9 people in a fast paced work environment including to the bioburden, endotoxin, and trace penicillin testing laboratories for all in-process, drug substance, raw material and water sample testing.Coordinated product release information to meet the site objectives in a fast paced and fluid environment.Provided leadership on SOP development, cGMP compliance, USP, EP and JP regulations, validation of laboratory equipment (incubators, autoclaves, KQCL instrumentation), and method development for in-process and raw material samples.Supported commercial manufacturing by providing technical support and through involvement in numerous cross functional teams.Participated in regulatory inspections by the FDA, EMEA, and other regulatory agencies by providing written and verbal explanations to questions that arise.Prepared and reviewed sections for BLA filings of several products.Oversaw the daily activities in the testing laboratories, including utility and environmental sampling.Responsible for investigations involving different aspects of the laboratory and manufacturing support.Conducted performance development of direct reports, participate in the hire of new employees and managed training activities.Performed review of cleaning validation protocols for the validation group, which encompassed review of technical data (bioburden, endotoxin, TOC) and support for OOS investigations.

Brentford, Middlesex, Gb

Analyzed raw materials, finished products, environmental and water samples according to USP, EP, JP and FDA guidelines in a manufacturing facility.Tested samples using KQCL, LAL gel clot, and bioburden methodology.Performed environmental monitoring and water collection/analysis for all production processing areas.Wrote and revised numerous SOPs and method validations for new products.Led several projects requiring communication between different departments and clients.Transferred new methods and products into the facility by being a lead contact for SOP development.Lead microbiology for bringing new product introduction into the facility including communicating with all groups on coordinating testing and budgeting for testing.

Harleysville, Pa, Us

Researched technical issues and problematic situations in order to provide efficient and effective solutions.Performed investigations on required microbial issues for all of North America and most global facilities.Traveled to and communicated with other facilities in order to implement changes in procedures in concurrence with training with global training of employees.Conducted internal audits of production facility and of other facilities associated with the company.Maintained all activities of the West Point Microbiology facility according to cGMP guidelines.

Southampton, Pa, Us

Maintained Quality Assurance procedures and paperwork according to cGMP requirements for all clients.Analyzed and recorded results for all tested materials.Communicated with clients on results and proper testing procedures of their products.Practiced general microbiology testing according to USP regulations, including microbial limits testing of pharmaceutical and personal care products (raw and finished materials) and preparatory testing.Prepared and validated all laboratory media.

Ms, Microbiology

Bs, Biology