Joy David Email & Phone Number

South San Francisco, Ca, Us

San Francisco, Ca, Us

San Francisco, Ca, Us

Quality oversight of GXP (GCP/GLP/GMP) contract service providers (CSP): audit planning, scheduling, maintenance of approved supplier lists, audit execution, response tracking, CAPA, resolution of non-conformances, and performance tracking (CRO, CMOs, Clinical Sites, etc.), develop quality system processes and procedures, supplier audits of CMOs and clinical distribution, QA Operations: non-conformance mgmt, chance control, review of equipment qualification/validation and stability reports.Sector: Pharmaceutical - Small Molecule (Clinical) Product: CKD based anemia, Roxadustat Regulations: 21 CFR Part 58, 210 & 211, ICH Q7, Eudralex GMP, E6R2

Quality oversight of GXP (GCP/GLP/GMP) contract service providers (CSP): audit planning, scheduling, execution and maintenance of approved CSP lists, audit execution, response tracking, CAPA, resolution of non-conformances, and performance tracking (CRO, CMOs, Clinical Sites, etc.), develop quality system processes and procedures, implement enterprise quality management system (Veeva) upgrades, GxP training and annual audits, support QA Operations GMP release for clinical materials (e.g. batch release, specification review, temperature excursions, etc.) to clinical study sites, record managementSector: Pharmaceutical - Start-up Oncology (Clinical) Regulations: 21 CFR Part 58, 210 & 211, ICH Q7, Eudralex GMP, E6R2

Leverkusen, North Rhine-Westphalia, De

External GMP inspection preparation, pre-approval inspections, annual product reviews (APR), site master file, drives license registrations & GMP renewals, QA support to deficiency letter responses and health, authority inquiries, CMC submission preparation, executes inspection readiness training and preparation activities, observation response, develops quality system procedures and site training, development & tracking of quality metrics (QMRs), lead facility walk-throughs, compliance council, gmp compliance supporting product distribution in 70+ countries Regulation Experience: FDA, PMDA (Japan), MFDS (Korea), Health Canada, TGA (Australia), Swiss Medic, CFDA (China), United Arab Emirates (UAE), Turkey Ministry of Health (MoH), Taiwan, Mexico, Latin America, Emerging Markets;Sector: Pharmaceutical - BiologicsReg Status: Commercially Licensed Product, launch/license approval of 2 next generation hemophilia products (w/ in last 5 yrs.)Regulations: 21 CFR Part 210 & 211, ICH Q7, Eudralex GMP, Quasi (Japan), Canadian GMPs, Swiss Medic

Supplier quality management, supplier qualification (end-to-end: sourcing & identification, process validation, part qualification/release), quality system audits, support receiving inspection to ensure timely release and prevent line down situations, first article inspection, sampling plan development, develop supplier improvement plans, risk management, quality metrics reporting (QMR), non-conformance investigations, CAPA, inspection plans, equipment validation (dimensional measuring equipment), design control, new product introduction & launch, secondary sourcing Sector: Medical Device - Class III (active implantable, cardiac)Products: left ventricular assist (LVAD), pulmonary (PVAD), VADs, e.g., Heart Mate II, Centrimag, etc.Reg Status: Commercially Licensed Products, development and launch of next generation products Regulations: ISO 13485, ISO 9001, ISO 14971, ISO 17025, IPC 610Activities: Thoratec Green Belt Program (Six-Sigma/DMAIC)

Deerfield, Illinois, Us

Device design control, responsible for complaint management program: investigation, failure analysis, metrics tracking, inspection support, tracking supplier quality metrics, material qualification, shipping & sterilization validations, updating and evaluating the product risk profiles, quality risk management, technical support for-cause audits, quality management review reporting (QMR), external inspection support, executing change controls, new product launchesSector: Medical Device - Class IIProducts: Coseal, Floseal, TiseelReg Status: Commercially Licensed Devices (hemostats)Regulations: ISO 13485, ISO 9001, ISO 14971, ISO 17025Activities: Baxter Green Belt Program (Six-Sigma/DMAIC)

Leverkusen, North Rhine-Westphalia, De

Data mining, statistical analysis, trend identification, in-process control (continuous process verification), deviation investigations, CAPAs, SWOT initiatives, change point analysis, failure investigation, specification limit determination, MATLAB, Minitab, multi-factorial analysis, annual product reviews (APR)/product quality reviews (PQR), statistical comparability analysis, data analysis to support CMC license changes or regulatory submissions Sector: Pharmaceutical - Biologics, Commercial Manufacturing Regulations: 21 CFR Part 210 & 211, ICH Q7, Eudralex GMP, Quasi (Japan), Canadian GMPs, Swiss Medic Activities: Bayer Black Belt Program (Six-Sigma/DMAIC)

Computational chemistry, combinatorial molecule development, ADME principles, Molecular modeling, drug design and discovery, regressions analysis, chem-informatics, predictive modeling, develop small molecule databases, computational chemistry, receptor targeting, and combinatorial modeling, recursive partitioning, activity detection, Cerius2 modeling, bioinformatics using SMILES strings Sector: Pharmaceutical early phase Development & Clinical

Wilmington, Delaware, Us

Genomics, sequencing, bio-informatics, BLAST/PHRAP, UNIX, SQL, database development and design planning, executing test scripts, legal, prior art screening, support intellectual property (IP) patent office (PTO) high-throughput submission pipeline, computational programmingSector: Biotech - Genomics & Bioinformatics

Santa Cruz, Ca, Us

Researcher on Mouse Growth Hormone Releasing Hormone, rodent tissue collection and sample prep, radio immuno-assays (RIA), lab technician in endocrinology lab, buffer prep, reagent inventory managementThesis: “Growth hormone releasing hormone in mouse placental extracts”