JAMIE JAMSHIDI Pharmaceutical Quality Control (PQC) Consulting, Inc. was founded by Jamie Jamshidi in 2007. Jamie formed this company with the goal of assisting biotech and pharmaceutical companies comply with the most current regulations. Jamie has over 19 years of industry experience including 9 years in small molecules and over 10 years in biologicals. She retired from Amgen, Inc. in 2007 after 17 years of service with the company. Some of Jamie’s major accomplishments during include launching Amgen, Inc.’s first commercial product Epogen® and subsequently, Neupogen®. Jamie was a key team member in the start-up of numerous new Amgen, Inc. GMP facilities in the U.S., Puerto Rico and Europe. She helped establish a number of new departments at Amgen including Contract Manufacturing and Small Molecule Quality Assurance. She was also instrumental in helping Amgen obtain approval of their first small molecule product, Sensipar®.  Jamie was the key Amgen Quality Assurance representative at several FDA and other regulatory inspections at contract manufacturing sites. She has extensive knowledge and expertise in the areas of Quality Assurance, Manufacturing, Validation, Analytical Labs, Regulatory Submissions, Regulatory Inspections (PAI), Project Management, Managing Contract Manufacturing facilities, Technology Transfer and Team Leadership. Jamie has a broad understanding of the entire drug development process for both proteins and small molecules. She has extensive knowledge of U.S. FDA, European and Japanese drug manufacturing regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives. She also has extensive experience in the development and commercialization of pharmaceuticals at all process stages, including Drug Substance (API), Drug Product, Packaging, and Labeling. jamiej@pqcconsulting.com

MICHAEL CHAN, MBA Michael Chan joined PQC Consulting, Inc. in 2008 as Sr. Vice President and CFO.  He has over 18 years of experience in the pharmaceutical and biotech industry with emphasis in manufacturing, capital projects and strategy development. Mike worked at Amgen, Inc. from 1991 until 2005 and had held various management positions in Contract Manufacturing Operations, Logistics and Capital Projects.  He was the CMC Team Leader for Vectibix®, an EGFr antibody and abarelix, a GnRH antagonist peptide where he had responsibility over manufacturing, process development and supply chain sub-teams.  In those capacities he led his technology transfer teams towards successful implementation of production processes at various API and drug product contract manufacturing facilities. Furthermore, Mike was the lead negotiator for a number of large partnership collaboration and contract manufacturing agreements which incorporated demand forecasting and performance incentives for product commercialization. Mike was also responsible for building Amgen's National Distribution Center in Louisville, KY and Amgen's first large scale mammalian cell culture and bacterial fermentation clinical manufacturing facility in Thousand Oaks, CA.  Prior to working at Amgen, Mike worked at G. D. Searle, now a unit of Pfizer, where he managed CGMP capital projects at their Toronto solid dosage facility. Mike had presented at the annual BIO International conference as well other technical conferences in the subject of CGMP manufacturing and strategy.  He has also published several articles for the American Pharmaceutical Outsourcing journal. Mike received his B.S. in Mechanical Engineering from the Illinois Institute of Technology and his MBA from the UCLA Anderson School of Management. mikec@pqcconsulting.com

JOHN F. HAURY, Ph.D, CQE, CQM Dr. John Haury joined PQC Consulting, Inc. as Sr. Consultant specializing in statistical analysis.  His professional expertise includes sampling for improving measurement systems, sampling for process control (SPC) and data analysis for capability improvement and error reduction.  Dr. Haury is also an expert in design and analysis of experiments, the single most effective and efficient method for breakthrough improvements in quality, cost reduction and through-put. Dr. Haury started his career at Heinz Foods as a research scientist where he developed a low-calorie french fry for Ore-Ida Foods (a subsidiary of Heinz).  He earned certifications from American Society for Quality as a Quality Engineer (CQE) with emphasis in statistics, and as Quality Manager (CQM) and became Total Quality Management Statistician at Ore-Ida Foods.  As a company statistician and quality improvement specialist, Dr. Haury applied and taught Six Sigma methods.  He became the company expert on statistics for continuous improvement of measurement systems, production processes and experimentation. Subsequent to Heinz, Dr.Haury was Associate Director of Six Sigma and Quality Engineering at Amgen, Inc. from 1997 to 2007 where he developed a new standardized procedure for lot acceptance sampling and verification using confidence statements to reduce actual sampling requirements. John Haury received his Bachelors degree from University of California at San Diego with High Honors and his Ph.D from Harvard University.  johnh@pqcconsulting.com

ELIZABETH BERGAN Elizabeth Bergan joined PQC Consulting, Inc., as a Senior Consultant. She has over 10 years of clinical research experience in the pharmaceutical and medical device industry.  She recently held the position of Managing Partner for Eye Trials, a contract research organization overseeing a number of multi-center clinical trials.  Prior to that, she had held various management positions at STAAR Surgical including Manager of Clinical Affairs.  Her clinical studies experience includes protocol design, trial site initiation, study close-out, final data collection and submission of Pre-Market Application (PMA).    At STAAR Surgical, Elizabeth managed several large multi-center clinical trials and was instrumental in preparing clinical trial data for an FDA Advisory Panel meeting.  Consequently, her team was successful in obtaining FDA approval for STAAR Surgical Visian ICL™ .   She has extensive experience preparing for and participating in FDA Bioresearch Monitoring audits.   Through her various positions, Elizabeth has been involved with the development of policies and procedures for clinical protocol and case report form design, clinical monitoring, adverse event reporting, and clinical data management.  She has trained a number of employees on applicable FDA Guidelines and Good Clinical Practices (GCPs) as well as ICH Guidelines. Elizabeth received her Bachelors degree from the University of California at Davis Elizabeth@pqcconsulting.com

PAUL CHEN, Ph.D. Dr. Paul Chen is a Sr. Consultant with PQC Consulting, Inc. and has over 30 years of experience in pharmaceutical and biotechnology industries in the areas of R&D, Quality Control, Quality Assurance and Regulatory Affairs.  Dr. Chen recently retired from Amylin Pharmaceuticals, Inc. where he was Director of Regulatory Affairs with an emphasis in Chemistry, Manufacturing and Controls (CMC).  Previously, Dr. Chen held positions with increasing responsibilities at Pfizer, Agouron, Warner-Lambert, American Home Products and Boehringer-Ingelheim. Dr. Chen’s functional areas of expertise include analytical methods and specifications development, raw material and finished product testing and release, formulating regulatory strategy and guidance for drug development and maintenance after approval, preparation of common technical documents (CTD), IND/CTX, NDA/MAA, Annual Reports, DMF and comparability protocols.  He was responsible for the CMC sections of six approved NDAs, three approved MAAs and numerous supplements and amendments in the therapeutic areas of anti-infective, antiviral, cardio-renal, anti-hypertensive, neuropharmacology, diabetes and obesity.  Dr. Chen has also participated in a number of FDA PAIs. Dr. Chen received his B.S. degree from National Taiwan University and M.S. and Ph.D. in biochemistry from North Carolina State University and a Post-Doctoral Fellowship with NIH.  He is a member of the American Chemical Society, American Association of Pharmaceutical Scientist and Drug Information Association.   paulc@pqcconsulting.com

PEGGY SWEENEY-MCDONALD Peggy Sweeney-McDonald joined PQC Consulting, Inc. in 2008 as Program Director, Corporate Events and Conferences.  She is a professional conference and meeting planner, particularly focused on the development and management of professional programs, seminars, workshops and conferences for pharmaceutical and biotech industry. Peggy has over 10 years of experience in the event and meeting management. Prior to joining PQC Consulting, Inc. as Program Director, Peggy was the Manager of Meetings & Events for Oakwood Worldwide, the leader in corporate housing. Her responsibilities included event concept development, strategy and execution for domestic and international tradeshows as well as planning user conferences and annual high energy sales summits. Peggy has designed and developed event programs such as “Taking the Lead for Sales Success”, a triumphant strategy for a sales meeting theme which took advantage of the current pop culture fascination with professional ballroom dancing.  She has also designed “Step Up to the Plate”, a baseball themed event which was fun, approachable and educational.  Peggy has an amazing ability to seamlessly meld her theatrical background with her event management skills, ultimately creating unique custom interactive programs that consistently delight and engage our clients and their guests. An active member of Meeting Professional International, Peggy created and led the very popular workshop, “Discovering and Executing Creative Meeting Themes” for both the MPI Southern California Chapter Annual Trade Show and the annual Educational Summit.  Peggy was voted Shining Star of the Month for November 2005 and nominated for Shining Star of the Year for 2005.  Peggy has a B.S in Speech & Theatre from LSU and is a published author. peggy@pqcconsulting.com

SONIA GOURARY, M.S. Sonia joined PQC Consulting, Inc. as a Sr. Consultant specializing in our CGMP Compliance and Regulatory practice.  She brings over 20 years of pharmaceutical industry experience in small molecules and biologics.  Sonia’s breadth of experience includes computer, process, cleaning, laboratory and equipment validation, FDA compliance, business process analysis, project management and regulatory affairs. Sonia is considered an expert in computer validation of PLC, DCS, LIMS, BMS, enterprise systems and PC based systems involved in the manufacturing, testing, sales and distribution of pharmaceuticals. Sonia has conducted validation qualifications supporting manufacturing and testing arenas, reviewing and approving validation protocols, summary reports and SOPs, as well as representing the Quality Assurance function during FDA inspections. She was recently requested by the U.S. FDA to serve as a Compliance and Regulatory lecturer for the pharmaceutical industry covering various topics including computer validation in a GXP environment and other Quality related issues. She possesses an in-depth knowledge of product development and manufacturing processes with various types of pharmaceutical products (solid dosage, non-sterile and sterile liquids). Sonia’s had previously worked for some of the world’s largest pharmaceutical and biotech companies including Roche, Schering-Plough, Wyeth, Daichi Pharmaceuticals and Amgen. Sonia received her B.S. degree in Biology from Bloomfield College and M.S. degree in Biology from Montclair State University in New Jersey. She is an active member of the International Society for Pharmaceutical Engineering, American Society for Microbiology and the Parenteral Drug Association. sonia@pqcconsulting.com

 

At PQC Consulting, Inc. we are constantly seeking new talent to add to our team of professional consultants. If you have strong pharmaceutical and/or biotech industry experience and are interested in joining our team, please forward your resume to career@pqcconsulting.com