JAMIE JAMSHIDI PQC Consulting, Inc. was founded by Jamie Jamshidi in 2007.  Jamie formed this company with the goal of providing expert technical services, solutions, and training to pharmaceutical and biopharmaceutical companies worldwide. Jamie has over 23 years of industry experience including 13 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 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 L. KLEIN, Ph.D. Dr. Michael L. Klein joined PQC Consulting, Inc. as Vice President and Chief Scientific Officer (CSO).  Mike has over 27 years of experience in protein chemistry, including 19 years in the biotechnology industry.  He has served as the lead analytical scientist and product quality expert for recombinant proteins, monoclonal antibodies, and fusion proteins (native, pegylated, and radiolabeled), expressed in systems as diverse as mammalian cells, bacteria, and yeast.   Mike is an author of 12 scientific articles, and has given oral presentations at seven industry conferences. Prior to joining PQC, Mike was the Director of Analytical Sciences/Quality Control at Xencor, with responsibility for all internal and outsourced product testing and formulation issues. Prior to Xencor, Mike worked at Amgen for over 12 years, in Research (Protein Sciences), Process Development (Analytical Sciences), and Quality (Product Quality). He also worked at Protein Design Labs as a Scientist in Protein Chemistry, and at the City of Hope as a Postdoctoral Fellow in the Division of Immunology of the Beckman Research Institute. For the last several years, Mike has been a biopharmaceutical industry expert working both independently and as Senior Consultant with RMC Pharmaceutical Solutions, Inc., supporting a variety of commercial ventures in the fields of analytical sciences, formulation development, process sciences, and product quality. In 2008, he served as a lecturer at California State University, Channel Islands, teaching “Biotechnology in the 21st Century,” which is a course jointly offered by the Biology and Business departments. Mike has significant experience with biotech product development and regulatory filing, having been responsible for the drafting and review of CMC sections of numerous submissions at various stages of clinical development to the FDA and other health agencies for 16 different protein therapeutic products, including one which was successfully commercialized (Amgen’s Vectibix®) and others already on the market.  Mike has represented Analytical Sciences and Quality in several face-to-face meetings and teleconferences with the FDA, and has presented and served as a panelist at conferences co-sponsored by the biotech industry and regulatory agencies. Mike received his B.A. and M.S. degrees in Biochemistry at the University of Rochester, and his Ph.D. in Biological Chemistry at UCLA. m.klein@pqcconsulting.com

 

TIMOTHY G. GRASEL, PH.D. Dr. Timothy Grasel joined PQC Consulting, Inc. as a Scientific Advisor, with specialization in process development and manufacturing operations.  He brings 22 years of scientific and operational expertise to PQC Consulting. After five years as a research scientist at W.R. Grace & Co., where he led the development of poly(ethylene oxide) materials for biopharmaceutical applications, Tim joined Amgen in 1991.  At Amgen, he built a process scale-up and support capability for drug product manufacturing and provided expertise in polyethylene glycol (PEG) derivatization, protein formulation, lyophilization, filling, and packaging.  Tim’s leadership in these fields was a key factor in the successful commercialization of Amgen’s blockbuster drug Neulasta®.  In addition, Tim participated in numerous early-stage product development teams and provided leadership in successfully initiating clinical trials of several product candidates.  As Plant Manager for clinical bulk manufacturing and clinical filling and packaging, Tim led cross-functional teams that ensured successful new product and process introductions and provided consistent supplies of product candidates for clinical development. Immediately prior to joining PQC Consulting, Inc., Tim was Director of Technical Services at Baxter Healthcare, Inc., in Los Angeles.  At Baxter, Tim was responsible for commercial manufacturing support, troubleshooting, and maintaining product yield, and he led and sponsored initiatives to improve and enhance data reporting, compliance, and product yield. Tim earned his Bachelor’s degree from Michigan Technological University and his Ph.D. degree from the University of Wisconsin-Madison.  While at Wisconsin, Tim authored 18 peer-reviewed publications and three book chapters in the area of protein-surface interactions, polymer science, and biomaterials.  Tim is named as a co-inventor on seven U.S. patents. tgrasel@pqcconsulting.com

 

GLEN LAWRENCE, Ph.D. Glen Lawrence, Ph.D., has joined PQC Consulting, Inc., as Scientific Advisor, and serves as the firm’s chief expert in small molecule scientific development.  Glen has extensive experience in compound characterization, small molecule product development, strategic outsourcing, and CGMP manufacture and release.  Glen has participated in over 40 regulatory filings. While at Amgen, Glen applied his strategic management expertise and leadership skills in the initial development and expansion of the Small Molecule Pharmaceutics Group (SMP).  From 1996-2003, Glen led the small molecule Preformulation, Analytical and Formulation Development function as it grew from two staff members to 55.  As Executive Director of SMP Product Development from 2004-2007, Glen led the conversion of the R&D pilot plan into a CGMP facility for manufacturing and testing of Phase I/II solid oral dosage forms.  Glen led the drug product and analytical development of Sensipar®, Amgen’s first small molecule therapeutic to receive market authorization.  Glen was the Global CMC representative in meetings with the FDA and four international regulatory agencies throughout the clinical development and commercialization of Sensipar®, and was responsible for the sections associated with Quality by Design and Risk Assessment. Prior to joining Amgen, Glen was employed by Marion Laboratories, which later became Marion Merrell Dow and then Hoechst Marion Roussel.  As this site was later transitioned to Quintiles, Glen led the first external contracted event at Quintiles. Glen received his B.S. degree in Chemistry from Illinois State University, and his Ph.D. degree in Industrial and Physical Pharmacy from Purdue University. glen@pqcconsulting.com

 

ELIZABETH BERGAN Elizabeth Bergan joined PQC Consulting, Inc., as a Global Clinical Projects Leader. 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

 

MELISSA KIRKEGAARD Melissa Kirkegaard joined PQC Consulting, Inc. in March, 2009 as a Quality Professional.  Melissa has more than 17 years of experience in the biotech and pharmaceutical industries with emphasis in stability program management, project management, strategy development, and technical training. She worked at Amgen from 1991 to 2007, and held positions in QC Chemistry, Stability Quality Control, and Corporate Quality. Melissa has substantial experience in stability programs, including pre-clinical, clinical and post-commercial products. She managed the stability programs for Neupogenâ and Neulastaâ through successful regulatory filings and post-approval regulatory approved changes. Melissa wrote a comprehensive product stability manual to align multiple sites within Amgen with efficient, cost-effective stability programs, and presented multiple interactive training sessions for cross-functional audiences. She developed tools to provide upper management with concise communication regarding stability programs, developed efficient strategies for protocol testing, and completed assessments of ongoing stability programs that saved the company more than a million dollars in unneeded testing. In her various positions, Melissa has used her logical scientific reasoning to lead teams and manage projects. She was a member of Amgen’s Toastmasters club and enjoys giving engaging presentations. Melissa received her Bachelor of Science degree from the University of California at Santa Barbara. melissa@pqcconsulting.com

 

CONNIE COLEMAN, M.A., M.B.A. Connie Coleman joined PQC Consulting in September 2009 as Director, Sales and Marketing. Connie has over 25 years of experience in marketing, sales, and technical communications at companies that include Ixia, Spirent Communications, ECI Telecom, Toshiba, Fujitsu, Kyocera, and TRW.  She has been instrumental in establishing record sales of training and support services, as well as products that include industrial and medical ceramics, office and educational equipment, telecommunication and data systems, textiles, and consumer gift items. Most recently, Connie worked for Ixia—a  worldwide leader of networking diagnostic equipment—as Sr. Manager, Technical Publications, managing the company’s worldwide team of writers. An accomplished writer herself, Connie has authored many marketing, technical, and academic publications, receiving awards for research and presentation. She has also used her writing skills to promote several non-profit organizations for which she is an avid volunteer.  Her volunteer work resulted in her receipt of Ixia’s Community Service award in 2007. Also an accomplished designer, Connie has applied her design skills to a variety of graphic and textile projects for corporations and private companies. Connie has a B.A. and M.A. in Communications from California State University, Fullerton; an Executive M.B.A. from the University of California, Irvine; and an A.S. in Design from the Art Institute of California. Her M.A. thesis was influential in altering Toshiba’s marketing and product inventory processes, saving the company millions of dollars. Connie’s longstanding interest in science and health, coupled with her volunteer experience in hospice, animal therapy, and crisis counseling has led to her latest educational pursuit:  a Ph.D. in Health Psychology from Capella University. connie@pqcconsulting.com

 

DONNA SHAFFER Donna Shaffer joined PQC Consulting in January 2010 as an Administrative Assistant and Financial Advisor.  She has over 20 years of financial experience and over seven years in the biotechnology industry.  She has extensive experience in treasury, budgeting, financial planning, financial analysis, strategic planning, SAP Business Warehouse and product/portfolio management.  She has lived and worked aboard and has both domestic and international experience with multinational Fortune 100 companies, which include - Xerox (NYSE:XRX); Computer Sciences Corporation (NYSE:CSC) and Amgen (NASDAQ: AMGN).  Donna earned her BS in Finance from the University of Southern California in Los Angeles and her MBA from Pepperdine University. Donna@pqcconsulting.com

 

SAMARA DINER Samara joined PQC Consulting in July 2009. She is currently the Operations Manager, but has also held the position(s) of Office Manager, Project Manager and Sales and Marketing Intern.  Prior to joining PQC, Samara worked as a Technical Marketer, as well as a Research Assistant in a bacteriology research lab. While completing her Bachelor of Science degree in Biochemistry and Molecular Biology, Samara wrote her thesis on the autotrophic growth of Azorhyzobium bacteria.  She also earned a Bachelor of Arts in Legal Studies from the University of California, Santa Cruz. Samara recently completed her Master of Science in Biotechnology and is expected to be done with her Masters in Business Administration next Spring from California State University, Channel Islands. samara@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