Daniel Roberts Email & Phone Number

San Francisco, California, United States

Pharmaceutical and Biotechnology Regulatory Compliance Policy Advisor

San Francisco, California

Regulatory and compliance assistance for the Pharmaceutical and Biotechnology industry.

Pharmaceutical Consulting

New Delhi Area, India

Assistant Country Director (India Operations Drug Program)Conducted pharmaceutical inspections throughout India.Received Agency recognition awards for excellence in conducting Pharma InspectionsCoordinated with India counterpart Regulatory counterparts to achieve compliance with international Pharmaceutical cGMPs.Presented at GMP/Data Integrity training workshop with foreign government regulatory counterparts.United States Foreign Diplomat representing USFDA in IndiaUS Government Secret Security ClearanceConducted over 100 pharmaceutical inspections as a lead investigator throughout USFDA career. 23 USFDA Warning Letters and Untitled Letters as well as 5 Import Alerts were issued as a result of the inspections conducted throughout USFDA career.

San Francisco Bay Area

GDUFA Drug Investigator.Primarily conducted international cGMP and Pre-Approval Inspections of Generic Pharmaceutical Companies.

San Francisco Bay Area

Acting New Drug Application Pre-Approval Program Manager for San Francisco District Office.

San Francisco Bay Area

Graduate of FDA Law and EvidenceGraduate of FDA Drug SchoolGraduate of FDA Pre-Approval Drug Inspections programGraduate of FDA Active Pharmaceutical Ingredient Inspections programGraduate of FDA Process Validation for Drug Manufacturing Operations and Automated Systems Inspections programGraduate of FDA Bio-therapeutic (Biotechnology) Manufacturing Inspections program Graduate of FDA Computer Aided Inspections programGraduate of FDA Human Tissue and Cells Inspections programGraduate of FDA Industrial Sterilization and Aseptic Processing programGraduate of FDA Animal Medicinal Drug User Clarification Act (AMDUCA) programGraduate of FDA/North Carolina State Upstream Cell Culture Bio-processing programGraduate of FDA/North Carolina State Downstream Purification Bio-processing programGraduate of FDA/North Carolina State Quality Control Analytical Laboratory program Member of FDA Foreign Inspection CadreConducted FDA Inspections/Audits throughout the United States, India, Germany, France, United Kingdom, China, Switzerland Graduate of FDA Pharmaceutical Inspectorate programLevel 1 Certified FDA InvestigatorReceived Agency Awards for Excellence

QC Associate Scientist III Bayer HealthCare’s Pharmaceuticals Division develops and sells innovative and highly effective drug products for the treatment of life-threatening conditions but also for disorders that markedly impair quality of life and life expectancy.· Tested Hemophilia A recombinant Factor VIII (Kogenate) product under FDA compliant GMP guidelines· Performed release testing, in-process and long-term product stability analysis· Analyzed Kogenate Factor VIII purity and molecular integrity via electrophoresis· Performed qualitative western blot analysis and silver stain· Performed quantitative coomassie blue SDS PAGE analysis· Maintained statistical trend charts of released material· Reviewed test records and released tested product to Quality Assurance· Assisted in method development and validation of new protocols, procedures and assays· Assisted in developing and implementing a validated TECAN ELISA automation assay· Assay and reagent validations/qualifications per FDA guidelines· IQ/OQ/PQ Densitometry instrument· Participated in a QC Analytical Method Transfer (AMT) for Leukine product· Developed and performed validation protocol for the transfer of 5 electrophoresis assays to a new Bayer facility· Author of 6 Bayer SOPs· Submitted 15 new pharmaceutical product ideas to corporate headquarters in Germany· Awarded a Bayer recognition prize for innovation· Chairperson of the Bayer Junior Board Council

QC Associate Analyst A large private international company, that specializes in providing a broad range of various products and antibodies to the scientific research community. Primary responsibilities include the research and development, validation, and optimization of immunoblotting assays.· Assisted in developing and validating approximately 2100 different types of siRNA gene silencers· Developed and designed western blot protocols using various bioinformatic tools· Analyzed relative rates of protein expression and characterization in different tissues and cell lines· Assisted in developing an optimal bioassay method for siRNA transfection and incubation periods in mammalian cell lines· Conducted a seminar in October 2004 that introduced a novel type of amplified high-density microarray detection· Conducted a seminar in March 2004 that introduced a prediction model for predetermining the efficacy of a targeted siRNA gene knockdown· Performed over 10,000 western blots and validated approximately 13,000 different antibodies· Verified molecular weights of recombinant purified proteins· Validated Antigen peptide sequence cross-species reactivity· Results from western blot protocols and experiments are published in the company catalog· Coordinated, designed and performed various types of IP (immunoprecipitation) experiments· Prepared nuclear extracts, tissue extracts, and whole cell lysates· Worked closely with other scientists from all aspects of the company including: immunodiagnostics, monoclonal production, polyclonal production, recombinant protein production, and cell culture· Investigated discrepancy report claims by customers and designed appropriate protocols· Investigated discrepancy report claims regarding specific lots or batches of released product· Trained and supervised new staff and visiting international employees

Peptide/Polyclonal Antibody Production Associate I, October 2002 through August 2003My duties as a production associate involved purification and production of goat and rabbit polyclonal antibodies.· Performed raw salt-cut precipitations and dialysis· Conducted ELISA analysis on purified antibodies· Affinity column chromatography· Propagated and harvested bacteria· Maintained mammalian cell cultures· Entered production lot data information into laboratory notebooks and computerized databases

Pilot Plant Operator Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.· Assisted in scale up production of pharmaceutical products· Facilitated pilot plant bacterial and yeast fermentation· Initiated, propagated, and harvested large scale fermentation reactors· Assisted in maintaining viable mammalian cell lines (CHO)· Performed scheduled bioassays that included:· Cell population density determination via UV/IR spectroscopy· Performed gas chromatography assays to analyze nutritional viability of culture media· Analyzed culture media toxicity using YSI Biochemistry analyzing instruments· Assisted in developing and validating an effective new method for sterile culture media feed delivery· Participated in large-scale protein purification (HPLC and size exclusion chromatography)· Assay and reagent validations/qualifications per FDA guidelines· Facilitated the induction of large-scale fermentation reactors