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Skills and Qualifications:

Twenty eight years of industry experience in Quality and Regulatory Affairs.

Experience in Quality operations:

  • Quality Control.

  • Quality Assurance.

  • Quality Engineering: Validations of methods, process, and equipment IQs, OQs, and PQs.

  • Performed GMP, GLP, and GCP audits.

  • Hosted inspections: GMP (FDA, State of California, and EU), GLP FDA, and GCP FDA.

  • PAI experience.

  • Managed small and large (up to 61 regular full time employees) quality operations departments.

  • Document Control.

  • Training program.

  • PAI experience.

  • Drug product and active pharmaceutical active ingredient stability.

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Experience in Regulatory Affairs including:

  • Ophthalmology.

  • Oncology.

  • Immunology.

  • Dermatology.

  • Anti infective.

  • Cardiovascular.

  • Filing experience in both paper and electronic formats.

  • NDA approved for AzaSite (1% azithromycin, ophthalmic), April 27, 2007 by FDA.

  • BLA approved for Raptiva, Oct. 27, 2003 by FDA.

  • Regulatory generalist and CMC expert.

  • Compile regulatory filings: IND, NDA, BLA CTA (Canadian), NDS (Canadian NDA), and Orphan Drug Status (EU).

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Products Expertise:

Biologics – Recombinant Proteins and Blood Products including but not limited to:

  • rhGH (Protropin/Nutropin).

  • rt-PA (Activase).

  • Gamma interferon (Actimmune).

  • DNAse.

  • Anti-CD11a (Raptiva).

  • Recombinant factor XIII (Kogenate).

  • Bactericidal increasing protein (Neuprex).

  • Alpha-1 protease inhibitor (Prolastin).

  • Anti thrombin III.

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Pharmaceuticals: Parenterals, solid dosage, and topicals products including but not limited to:

  • Fludarabine phosphate (Fludara).

  • AzaSite (1% azithromycin, ophthalmic).

  • AzaSite Plus (1% azithromycin, and 0.1% dexamethasone, ophthalmic).

  • Oligonucleotides (Vitravene and others).

  • Synthetic peptides.

  • Vitamins.

  • Thyroid tablets (co-authored USP monograph).

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Analytical and Biochemistry Expertise:

  • Method development and validation.

  • Extensive analytical experience (chromatography, gels, spectroscopy, in vitro activity assays and many others).

  • Testing experience (quantitative assays, impurity tests, clinical analyzers, specialized tests e.g. peptide maps).

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Project Management:

  • Project team member on many Project Teams since 1992.

  • Project team Leader/Manager for three Project Teams.

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Work Experience:

10/2007-Present: Auk Technical Services
Consultant
Works with clients in the pharmaceutical, biologic, and biotechnology industries to develop quality assurance and regulatory strategies for compliance with FDA regulations by:

  • Conducting assessments of client studies, procedures, and programs to determine compliance.

  • Provide corrective action to bring procedures and processes into compliance.

  • Provide Quality support for GMP, GLP, and GCP compliance.

  • Provide training.

  • Provide regulatory strategy and services for regulatory filings.

  • Analytical analysis and solutions for testing and development regulatory issues.

  • Provide Quality consulting/contracting services for BioTeKnowledge (BTK) as a Senior Consultant.

  • Provide consulting/contracting services to China for Automated Quality Solutions (AQS) as a Senior Consultant.

  • Serve as an instructor for Regulatory Affairs classes for the Sciences, Biotechnology and Mathematics certificate program at the University of California, Berkeley.

  • Served as an instructor for Regulatory Affairs and Drug Product/Drug Substance Stability classes for certificate programs offered by the Center for Professional Advancement and Education (CfPIE).

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2/2010-12/2012: University of California San Francisco, San Francisco, CA
Head of Quality Assurance for the Drug Product Services Laboratory and Regulatory Affairs

  • Responsible for QA GMP operations.

  • Advise for Pharmacy Quality operations.

  • Compliance.

  • Change control.

  • Responsible for issuing, tracking, resolution of deviations.

  • Responsible for corrective and preventive action.

  • Document control.

  • Validation.

  • Products – Starting up a contract aseptic fill facility operation.

  • Regulatory affairs generalist.

  • Electronic submissions.

  • Responsible for CMC of UCSF’s prostate cancer IND.

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4/2006 – 9/2007: Regulatory Affairs and Quality at InSite Vision, Alameda CA
Vice President

  • Responsible for the integration of Regulatory Affairs and Quality operations into the business plan of the company.

  • Direct the activities of 3 Regulatory staff and 7 Quality staff.

  • Regulatory submissions in both electronic and paper format.

  • Submitted a New Drug Application for company’s ophthalmic anti-infective topical drug AzaSite™ and was approved by FDA.

  • Applied for and received a PDUFA application fee waiver.

  • IND submission for company’s combination ophthalmic topical drug AzaSite Plus™.

  • Oversaw pre approval inspection (PAI) remediation activities.

  • Hosted a successful FDA sponsor monitored audit (GCP).

  • Serve as project manager for various projects.

  • Interface with the investment community and Board of Directors.

  • Involved with the strategic planning of the company.

  • Products – Ophthalmic and otic topicals.

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2/1999 – 3/2006: XOMA (US) LLC, Berkeley CA.

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8/2003 – 3/2006: Senior Director Regulatory Affairs and Compliance

  • Direct the Regulatory Affairs department activities of up to 4 employees.

  • Direct all Regulatory Affairs department operations.

  • Approve all regulatory submissions.

  • INDs include both electronic and paper submissions.

  • BLA approval of Raptiva by FDA.

  • Ten open INDs over a period of 3 years and two CTAs (Canadian INDs).

  • Direct technical writing for Regulatory Affairs, Clinical Development, and Biometrics departments.

  • Responsible for GCP compliance program.

  • Provide regulatory approval strategy for pre and current IND products.

  • Serve as Regulatory Affairs representative on various projects.

  • Serve as the Project Team Leader for two products and the Grant and Contract Team.

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2/1999 – 8/2003: Vice President, Quality

  • Direct the Quality Department activities of 40 regular full time employees.

  • Quality Control testing (Microbiology, Chemistry, and Biochemistry) – Environmental monitoring, water systems, raw materials, in process, bulk drug substance, and final product.

  • Quality Assurance – GMP and GLP compliance, document control, incoming quality assurance (i.e. raw material inspection), change control, deviations, audits (conduct and host audits), product (& raw material) release.

  • Quality Engineering – Company wide validation programs; utilities, equipment, process, computer, and test methods.

  • Overall responsibility for the stability program.

  • Overall responsibility for implementing PAI remediation.

  • Company wide GMP training program.

  • Document review – BLA CMC, INDs, SOPs, analytical methods, etc.

  • Set product specifications.

  • Project Manager for one project team and department representative for other project teams.

  • Part of implementation team for Sarbanes Oxley compliance.

  • Products – Recombinant proteins (including several antibodies) and one synthetic peptide.

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8/1997 – 2/1999: Berkeley HeartLab, Berkeley, CA.
Vice President, Development

  • Responsible for company’s laboratory R&D activities.

  • Methods development and validation.

  • Contractor review and assessment – Serve as company project manager; interfacing, directing, reviewing, and making recommendations on projects with outside contractors.

  • Evaluate new products and technologies.

  • Laboratory cost estimates.

  • Facility planning.

  • Presentations to Board Members.

  • Products – Advanced cardiovascular testing services.

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3/1995 – 7/1997: Bayer, Berkeley, CA.
Manager, Quality Control Chemistry & Biochemistry Operations

  • Products – Advanced cardiovascular testing services.

  • Directed the Quality Control department activities of 8 groups with 61 regular full time employees plus a variable number of temporary employees.

  • Directed Quality Control testing; chemical environmental monitoring, water, raw materials (including inspection), in process, bulk drug substance, final product, and stability.

  • GMP compliance.

  • FDA issues (inspections and correspondence).

  • Methods development and validation.

  • Reviewed documents – PLAs, SOPs, Analytical Methods, etc.

  • QA product representative for Prolastin®.

  • Products – Recombinant and serum based proteins.

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7/1992 – 3/1995: Isis Pharmaceuticals, Carlsbad, CA.
Associate Director of Quality Control

  • Directed the Quality Control department activities of 11 regular full time employees.

  • Directed Quality Control testing; chemical environmental monitoring, water, raw materials, in process, bulk drug substance, and final product.

  • Department GLP/GMP compliance and other FDA issues (correspondence).

  • Methods development and validation.

  • Set product specifications.

  • Review documents – INDs, SOPs, analytical methods, NDA method protocols, etc.

  • Overall responsibility for stability program.

  • Served as Development Chemistry department project representative on various project teams.

  • Products – Oligonucleotides.

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6/1991 – 7/1992: Berlex Biosciences, Alameda, CA.
Associate Director of Quality Control

  • Directed the Quality Control department activities of 7 regular full time employees.

  • Responsible for the Quality Control operations at two sites.

  • Directed Quality Control testing; environmental monitoring, water, raw materials, in process, bulk drug substance, final product, and stability.

  • QC GMP compliance and other regulatory issues (inspections and meetings).

  • QC methods development and validation.

  • Reviewed documents – PLA CMC, NDA CMC supplements, SOPs, analytical methods, etc.

  • Products – Small organic molecules and recombinant proteins.

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1/1985 – 6/1991: Genentech, South San Francisco, CA.
Technical Supervisor

  • Developed and validated methods for IND, and PLA product submissions – Protein methods for activity, impurities (process and degradation products), identity (peptide maps), and Assay. Methods were used for Quality Control release and stability testing.

  • Assisted in set up of HP1000 Laboratory Information Management System and served as system manager backup.

  • Laboratory automation development and validation.

  • Areas of technical expertise involved with responsibilities were; HPLC (RP, SEC, and IE), automation (programming, interfacing, robotics), electrophoresis (CE, SDS-PAGE, and IEF), and GC.

  • Served as the company representative in a World Health Organization collaborative study for a new in vitro activity assay for human growth hormones.

  • Products – Recombinant proteins.

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4/1983 – 1/1985: Aventis (formerly Armour Pharmaceutical and US Vitamin), Kankakee, IL.
Senior Analytical Chemist

  • Improved and validated methods for NDA approved products.

  • Developed and validated methods for aNDA product submissions.

  • Participated in HPLC method transfers from facility in Tarrytown NY to Kankakee IL.

  • Played key role in developing USP monograph for the Assay for thyroid tablets.

  • Played lead role in troubleshooting QC assays and special projects.

  • Areas of technical expertise involved with responsibilities were; HPLC (RP, NP, and SEC), atomic absorption, electrophoresis (SDS-PAGE and IEF), computers, GC, and arc emission.

  • Products – The products covered a wide range of compounds; small organic molecules, proteins (from natural sources e.g. human plasma and animal bi-products), peptides, and metals.

 
Education:

1982: Ph.D. in Chemistry, Southern Illinois University at Carbondale. Field of specialization: Analytical Chemistry. Minor: Biochemistry.
1975: B.S. in Chemistry and Mathematics, Quinnipiac College, Hamden, CT. Quinnipiac College Scholarship. Graduated with Honors.

 
Certifications:

  • Hold license as State of California Pharmaceutical Exemptee “Designated Representative License Drug Wholesaler”.

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Publications and Presentations:

  • Presentation at the Third Midwest Analytical Symposium (1981, Columbia, MO) entitled “Enrichment of Trace Metals by Electrodialysis” by Ronald H. Carlson and James A. Cox.

  • Publication in Analytica Chimica Acta entitled “Quantitative Enrichment of Trace Levels of Ions by Electrodialysis” by Ronald H. Carlson and James A. Cox, volume 130, No. 2, page 313, 1981.

  • Publication in Clinical Chemistry entitled “Quantitative Electrodialytic Separation of Ions from Blood” by Ronald H. Carlson and James A. Cox, volume 28, No. 9, page 1986, 1982.

  • Publication in Fuel entitled “Estimation of the Inorganic to Organic Chlorine Ratio in Coal” by Ronald H. Carlson, Amy Larsen, and James A. Cox, volume 63, September, page 1334, 1984.

  • Presentation at the 1985 Pittsburgh Conference and Exposition on Analytical Chemistry and Applied Spectroscopy (New Orleans, LA) entitled “The Determination of Liothyronine and

  • Levothyroxine in Thyroid Tablets” by Ronald H. Carlson, David A. Long, Gary F. Burt, William J. Mayer, and Robert L. Garnick, No. 642.

  • Presentation at the 1987 Pittsburgh Conference and Exposition on Analytical Chemistry and Applied Spectroscopy (Atlantic City, NJ) entitled “The Determination of rt-PA Activity Using a Microcentrifugal Analyzer” by Ronald H. Carlson, Barbara A. Niepelt, and Robert L. Garnick.

  • Publication in Analytical Biochemistry entitled “The Determination of Recombinant Human Tissue-type Plasminogen Activator Activity by Turbidimetry Using a Microcentrifugal Analyzer” by Ronald H. Carlson, Robert L. Garnick, Andrew J. S. Jones, and Ann M. Meunier, volume 168, No. 2, page 428, 1988.

  • Publication in Advances in Laboratory Automation – Robotics 1987 entitled “Laboratory Robotics Applied to Endotoxin Analysis of Recombinant DNA-Derived Pharmaceuticals” by Ronald H. Carlson, Robert L. Garnick, Margaret M. Stephan, Dominick Sinicropi, Charles P. du Mee, and Claude Miller, volume 4, page 235, 1988. Also presented at the International Symposium on Laboratory Robotics 1987 (Boston, MA), No. 6.

  • Presentation at the Ninth International Symposium of Proteins, Peptides, and Polynucleotides (1989, Philadelphia, PA) entitled “HPRBC: A New Approach in Determining Biological Activity of Recombinant Proteins” by Ronald H. Carlson, Brent R. Larsen, Robert D. Hershberg, Robert L. Garnick, and Charles P. du Mee, No. 807.

  • Presentation at the International Workshop on Growth Hormone Assay Methodology (1990, London, England) entitled “High Performance Receptor Binding Chromatography: A Potency Assay for the Determination of Growth Hormone Activity” by Ronald H. Carlson.

  • Presentation at the International Biotechnology Exposition and Scientific Conference (1990, San Francisco, CA) entitled “The Determination of Protein Activity by High Performance Receptor Binding Chromatography” by Ronald H. Carlson, Session 11.

  • Presentation at the Thirteenth International Symposium of Proteins, Peptides, and Polynucleotides (1993, San Francisco, CA) entitled “Determination of DNA Oligomer Activity by Receptor Binding High Performance Liquid Chromatography” by Ronald H. Carlson, Jonathan R. Fitchett, and Glenn A. Breeze.

  • Presentation at the Sixth International Symposium on High Performance Capillary Electrophoresis (1994, San Diego, CA) entitled “Comparison of the Accuracy and Precision Between Capillary Gel Electrophoresis versus Polyacrylamide Gel Electrophoresis for Assay and Impurity Profile Determinations of Pharmaceutical Polynucleotide Samples” by Ronald H. Carlson, Jonathan R. Fitchett, and Anneva Bozick.

  • Publication in Journal of Chromatography A: Including Electrophoresis and Other Separation Methods entitled “Quantitative Capillary Gel Electrophoresis (QCGE) Assay of Phosphorothioate Oligonucleotides in Pharmaceutical Formulations” by G. Susan Srivatsa, Michael Batt, Jodi Schuette, Ronald H. Carlson, Jonathan R. Fitchett, Claudia Lee, and Douglas L. Cole, volume 680, No. 2, page 469, 1994.

  • Publication in Journal of Pharmaceutical and Biomedical Analysis Entitled “Selectivity of Anion Exchange Chromatography and Capillary Gel Electrophoresis for the Analysis of Phosphorothioate Oligonucleotides” by G. Susan Srivatsa, Patrick Klopchin, Michael Batt, Maria Feldman, Ronald H. Carlson, and Douglas L. Cole, volume 16, page 619, 1997.

  • Awards and Honors:

  • Bayer Excellence Award for the Continuous Improvement Process, 1996.

  • Bayer President’s Achievement Award for the Continuous Improvement Process (1996, Pittsburgh, PA). Member of first Bayer Berkeley team to finish as finalists for the award.

  • Bayer Excellence Award for the Continuous Improvement Process, 1997.

Ronald H Carlson Ph. D.

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