Experience

MediPrint Ophthalmics

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of Quality

  • May 2019 - Present

  Greater San Diego Area Clinical stage pharmaceutical company involved in developing sustained drug delivery of ophthalmic drugs. Responsibilities include QA/QC activities, Analytical method development and qualification, cGMP manufacturing support and technical writing for regulatory submission



Pharma Consulting

• Pharmaceutical / Biopharmaceutical Consultant

  • Sep 2017 - Apr 2019

  Greater San Diego Area Pharmaceutical/biopharmaceutical consultant in quality and CMC development activities of pre-IND, IND, NDA, and ANDA compounds. Quality Consultant at Ultimate Staffing Services and Method Validation Consultant at Validant.



Bachem

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Quality Control

  • Sep 2014 - Aug 2017

  Greater San Diego Area Responsibilities included managing QC Department as Head of QC, authorizing the release of cGMP analytical data for the cGMP manufacturing of peptides and oligonucleotides, support for CMC document preparation, participation in regulatory agency and customer audits as Subject Matter Expert (SME). cGMP activities include raw materials testing for peptides and oligonucleotide syntheses, in-process testing, final peptide API release and stability testing, authoring protocols and reports for… Show more Responsibilities included managing QC Department as Head of QC, authorizing the release of cGMP analytical data for the cGMP manufacturing of peptides and oligonucleotides, support for CMC document preparation, participation in regulatory agency and customer audits as Subject Matter Expert (SME). cGMP activities include raw materials testing for peptides and oligonucleotide syntheses, in-process testing, final peptide API release and stability testing, authoring protocols and reports for cleaning validation studies for manufacturing equipment and components, authoring SOPs for QC activities, method validation activities, Hold-time study for mixed solvent tanks, water testing, EM microbiology testing, and addressing OOS and investigations reports of QC activities for closure. Show less



GRAM Laboratories, Inc.

• Manager, Quality Assurance

  • Sep 2009 - Sep 2014

  Irvine, California Responsibilities, as Head of QA, included QA/QC activities for oversight of quality systems, auditing of cGMP analytical data and preparation of CofAs for the clients, SOP and test methods development, addressing OOS/deviation/laboratory investigations for closure, internal audit of laboratories, vendor audit program, training program, equipment calibration program, preparation and participation in Regulatory and Client audits. Product development activities included authoring method… Show more Responsibilities, as Head of QA, included QA/QC activities for oversight of quality systems, auditing of cGMP analytical data and preparation of CofAs for the clients, SOP and test methods development, addressing OOS/deviation/laboratory investigations for closure, internal audit of laboratories, vendor audit program, training program, equipment calibration program, preparation and participation in Regulatory and Client audits. Product development activities included authoring method development reports, method validation protocols and reports, and cleaning method validation reports. Supported numerous method validation and remedial method validation studies for multiple small molecule generic pharmaceuticals of parenteral and oral dosage formulation products. Show less



Self employed

• Consultant

  • 2008 - 2009

  Pharmaceutical/biopharmaceutical Consultant in product development, CMC and QC activities.



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Scientist, Pharmaceutical Analysis/Product Development/Formulation and Analytical Development

  • 2003 - 2008

  Group Leader and Project Director for supporting the product development activities of formulation development, lyophilization process development, method transfer, method validation, specification development, stability testing, cGMP testing of liquid, lyophilized, ophthalmic drug product and radiopharmaceutical kit containing small molecule, chelating peptide, and antibody fragment. Support was provided for CMC document preparation and pharmaceutical development report of a small molecule… Show more Group Leader and Project Director for supporting the product development activities of formulation development, lyophilization process development, method transfer, method validation, specification development, stability testing, cGMP testing of liquid, lyophilized, ophthalmic drug product and radiopharmaceutical kit containing small molecule, chelating peptide, and antibody fragment. Support was provided for CMC document preparation and pharmaceutical development report of a small molecule generic radiopharmaceutical for ANDA filing. The activities involved pre-IND, Phase I, II and III compounds containing small molecule, antibiotic, DNA duplex, protein, synthetic peptide and antibody.

• Senior Scientist, Group Leader

  • 2003 - 2008



Cardinal Health

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Scientist, Project Director, Product Development

  • 2003 - 2007

  San Diego Project Director for process and product development of a generic drug product containing a small molecule. Activities include formulation and lyophilization process development, method development, method validation, manufacturing of R&D lots of drug products, technology transfer to manufacturing facility for the successful manufacturing of registration batch of drug product, cGMP analytical testing, support for CMC documentation & pharmaceutical development report in ANDA filing.

• Senior Scientist

  • 2003 - 2007



XOMA

• United States
• Biotechnology Research
• 1 - 100 Employee

• Manager, QC Chemistry, Department of Quality (QA/QC)

  • 2000 - 2003

  Managed QC Chemistry Department and authorized the release of analytical data for cGMP manufacturing process for clinical supplies of protein,antibody and adenovirus based products and stability testing of Xoma's protein therapeutic products. The activities involved multiple IND compounds. Additional activities were method transfer activities, SOPs and test methods development for QC testing and compliance.



Ionis Pharmaceuticals, Inc.

• United States
• Biotechnology Research
• 500 - 600 Employee

• Assistant Director, Quality Control, Development Chemistry

  • 1999 - 2000

  Managed the Finished products testing area of drug substances and drug products containing oligonucleotides and authorized the analytical data for release testing, stability testing, reference standards, analytical methods validation and technology transfer to contract manufacturer and contract testing laboratories.

• Senior Scientist, Quality Control, Development Chemistry

  • 1994 - 1999

  Managed the Finished Products testing area and authorized the analytical data for release testing of clinical and toxicology supplies of drug products for pre-IND, IND, and NDA compounds containing oligonucleotides, reference standards, stability testing, in-process control testing of oligonucleotide drug substance manufacturing, raw materials testing, analytical method optimization for routine QC testing; technology transfer from Development Analytical Chemistry to Quality Control. Supported… Show more Managed the Finished Products testing area and authorized the analytical data for release testing of clinical and toxicology supplies of drug products for pre-IND, IND, and NDA compounds containing oligonucleotides, reference standards, stability testing, in-process control testing of oligonucleotide drug substance manufacturing, raw materials testing, analytical method optimization for routine QC testing; technology transfer from Development Analytical Chemistry to Quality Control. Supported the CMC document preparation for NDA submission, Pre-Approval Inspection activities and participated in Pre-Approval Inspection for ISIS’s first commercial product, Vitravene.



Hybritech, Inc.

• Research Scientist, Formulation Chemistry, Imaging & Therapeutic Research & Development (ITRD)

  • 1988 - 1994

  San Diego Held progressively more responsible research scientist positions including Manager of Formulation Chemistry and Team Leader for research projects. Managed the Formulation Chemistry Group and led the development of formulation and analytical methods for potential imaging and therapeutic radiopharmaceuticals of early stage development compounds containing antibody conjugate, small haptenic chelator, and peptide molecules and radioisotopes, Yttrium-90, Indium-111 and Technetium-99m.