March 2008

1. Biomedical Career Paths Medical Devices, In Vitro Diagnostics, Pharmaceuticals, Bio Technology, and more! Rich ShumwayCSUF ’74 VP Quality, Arbor Surgical Technologies, Inc. Member, CNSM Dean’s Advisory Council March 2008

2. Biomedical Career Paths Today’s Agenda I. Biomedical industries introduction Medical Devices– Heart Valves II. Specific Career Paths – which might be right for you? III. Recommendations To “Jump Start” Your Search R Shumway February 2008

3. Biomedical Career Paths – Good News! • Biomedical Industry In Calif. • 230,000 jobs • 2,600 biomedical companies – • Mainly L.A., O.C. and Bay Area • California Healthcare Institute (CHI) • “The biggest problem…is that there are • plenty of job openings but • limited [qualified] candidate availability,” • www.biospace.com – today over 1,000 job • openings in SD. OC and LA alone

4. Biomedical Career Paths • I. Biomedical Industry Types Include: • Medical Devices, In Vitro Diagnostics • Pharmaceuticals, biologics • Bio Technology • Clinical Studies • Regulatory Compliance R Shumway February 2008

5. The Three Types of Heart Valves Bovine Pericardial Valve Mechanical Heart Valve Porcine Heart Valve

6. PERIMOUNT Magna Model 3000 PERIMOUNT RSR Model 2800 No Cuff = Theoretically Better Laminar Flow through Valve

7. Valve implantation in hearts

8. II. Specific Career Paths, Job Types and Professions • Research and Development • Clinical Affairs • Regulatory Affairs • Quality Assurance • Manufacturing • Sales, marketing Biomedical Career Paths R Shumway March 2008

9. New Hire Desirable Traits & Competencies • Bachelors in Science, advanced degree, MBA • Very good communications skills • Problem solving capabilities • Team building leadership capabilities • Does the candidate have Initiative! Previous internship/job? R Shumway February 2008

10. III. 7 Key Tactical Recommendations To “Jump Start” Your Career • Know and study the biomedical businesses and key job types Demonstrate your knowledge during the job interviewing process! • Keep an “open minded” job search strategy – Break the “Catch 22” syndrome • Many different roads can lead to your first choice!

11. Summer internships/jobs are available, and are very valuable • Many opportunities found through casual or unexpected sources – always be communicating (family friends, neighbors, etc.) • Use internet job search tools • 2 of 3 new hires changed career decisions after summer intern work • Top hires out of school had internship experience

12. Interview as much as possible! • Prepare a resume no longer than one page • Study interviewing techniques • Practice with business friends and acquaintances • Do not be discouraged, keep interviewing! • Use professional staffing agencies, e.g. Kelly Scientific

13. Communications skills are very important • Prepare ahead of time a list of your strengths, experiences, problem solving capabilities, goals and objectives • Research the industry, the firm and products well ahead of the interview – Show enthusiasm • Consider communications skills improvement strategies, e.g. Toastmasters

14. Use free resources - magazines, web sites • Medical devices industry http://www.devicelink.com/mddi/ • In vitro diagnostics industry http://www.devicelink.com/ivdt/ • Pharmaceuticals industry http://www.devicelink.com/pmpn/ • www.biospace.com – see Biotech Beach >1000 jobs • Free trade shows - MDM West January Show in Anaheim

15. Career Fairs • BioSpace, Inc. is pleased to present the DeviceSpace Career Fair on Monday, March 17, 2008 at the Irvine Marriott in Irvine, CA.DeviceSpace Career Fairs give job seekers the opportunity to meet face-to-face with the region's elite science industry employers while presenting the opportunity to interview for hundreds of specialized open positions.

16. Be poised, confident, and persistent • Shortages of science graduates are growing! • Firms and people really do want you to succeed • Hiring people are extremely busy, do not misinterpret lack of response as a negative for you • One common key tactic - Be persistent, patient and do not get discouraged!

17. II. Specific Career Paths, Job Types and Professions • Research and Development • Clinical Affairs • Regulatory Affairs • Quality Assurance • Manufacturing • Sales, marketing Biomedical Career Paths R Shumway March 2008

18. Research and Development • R&D – Research and Develop new life saving biomedical technologies • Scientist/Engineer/Research Associates, Scientist/Engineers I, II, Senior, Staff, Principal, Distinguished • Engineering Managers, Directors, VP’s • Plus - Excellent salaries, technically interesting work, clinician interfacing, Located at Corporate HQ • Minus - MS, PhD strongly preferred, Engineers highly sought after, very competitive • Median Salary –$85,000 ($75,900 <5 yrs exp.)* • *MDDI 12/2005 Salary Survey Biomedical Career Paths R Shumway March 2008

19. Biomedical Career Paths Clinical Affairs Clinical Research Associates, I, II, Senior, Staff, Principal, Distinguished, Clinical Research Managers, Directors, VP’s Conduct animal and human clinical studies, monitor clinical trials, gather data and perform statistical analyses, negotiate contracts with our clinical investigators Plus- Excellent salaries, CRA certification programs are excellent, BS/BA is good Minus- MS, PhD, MD strongly preferred Median Salary -$91,400 , ($59,700 <5 years experience)* *MDDI 12/2005 Salary Survey R Shumway March 2008

20. Biomedical Career Paths Clinical profession web sites: Association of Clinical Research Professionals http://www.acrpnet.org Society of Clinical Research Associates http://www.socra.org/ R Shumway March 2008

21. Biomedical Career Paths Regulatory Affairs Manage Product Registration and Approval Processes Guide new drugs, devices or other products through complex approval processes. Prepare technical documents for submission to regulatory agencies, and know requirements of regulators. Regulatory Associate, Senior, Manager, Director, VP Plus- Excellent salaries, RAC certification excellent, Bachelors required Minus- Administrative in nature Median Salary - $91,400, ($59,700 <5 years experience)* *MDDI 12/2005 Salary Survey R Shumway March 2008

22. Biomedical Career Paths Regulatory Affairs Professional Society http://www.raps.org Orange County Regulatory Affairs Discussion Group http://www.ocra-dg.org/ R Shumway March 2008

23. Biomedical Career Paths • Quality Assurance • Manage product and process safety in all aspects of businessand know requirements of regulators, scientific patient advocate for safety • Coordinators, Associate • Chemist/Microbiologist/Biologist, I, II, Sr, Principal • Engineers I, II, Senior, Staff, Principal, Distinguished • Supervisors, Managers, Directors, VPs • Plus- Bachelors required, variety of positions, good for investigative nature, great certification programs • Minus- Problem focus, driving improvement, • Median Salary - $75,000, ($69,400 <5 years experience)* • *MDDI 12/2005 Salary Survey R Shumway March 2008

24. Biomedical Career Paths American Society of Quality (ASQ), Professional certifications: Certified Quality Technician, Certified Quality Engineer, Certified Quality Auditor, Certified Quality Manager , www.asq.org Juran Institute, www.juran.org, Association for the Advancement of Medical Instrumentation (AAMI), www.aami.org, R Shumway March 2008

25. Biomedical Career Paths • Manufacturing • Manage product manufacturing, manage work force, material flow, product cost structure, facilities, environmental controls • Associate I, II, III, supervisor, Manager, Director, VP • Plus- Most numerous opportunities, Bachelors required, excellent path to learn management • Minus- Focus on existing product manufacturing, cost reduction • Median Salary - $84,200,($73,000 <5 years experience)* • *MDDI 12/2005 Salary Survey R Shumway March 2008

26. Biomedical Career Paths • III. Biomedical Industry Types Include: • Medical Devices, In Vitro Diagnostics • Pharmaceuticals, biologics • Bio Technology • Clinical Studies • Regulatory Compliance R Shumway February 2008

27. Biomedical Career Paths • 1. Medical Devices, In Vitro Diagnostics Companies- • “Devices used in medical treatment, from a cardiac pacemakers to a wheelchair - Test and reagents kits and systems used in diagnostic evaluations” Examples: • Replacement heart valves R Shumway February 2008

28. Medical Industry Career Tracks • 1. Medical Device Industry • Heart valve Systems • Edwards Lifesciences, Irvine www.edwards.com • Medtronic, Irvine ,www.medtronic.com • Arbor Surgical, Irvine, www.arborsurgical.com • 3F Therapeutics, Irvine, www.3ftherapeutics.com • In Vitro Diagnostic Systems • Beckman Coulter Inc, Fullerton,www.beckman.com • Bone replacement • Interpore International,Irvine, http://www.interpore.com/ • Isotis OrthobiologicsIrvine, www.isotis.com • Vascular Stents • Edwards Lifesciences, Irvinewww.edwards.com • Cordis Webster Inc., Diamond Bar, www.jnjgateway.com/ • Intraocular lenses • Advanced Medical Optics, Irvine, www.amo-inc.com • Alcon, Irvine, www.alconlabs.com R Shumway February 2008

29. Biomedical Career Paths • 2. Pharmaceuticals, Biologics Companies- • “Products are usually drugs if they achieve therapy through chemical action or by being metabolized by the body”, Examples: • Intravenous therapy drugs • Neurological Dermatological drugs • Cancer/Chemotherapy drugs • Pain Therapy drugs R Shumway March 2008

30. Medical Industry Career Paths • Intravenous, Nutritional and Biological Pharmaceuticals • Baxter Healthcare, Los Angeles, www.baxter.com • BBraun McGaw , Irvine, www.bbraunusa.com • Biotechnology Pharmaceuticals • Amgen, Los Angeles, www.amgen,com • Genentec, S. San Francisco, genentecresearch.com • Ophthalmic Pharmaceuticals • Allergan, Irvine,www.allergan.com • Generic Pharmaceuticals • Watson Pharmaceuticals, Carona, www.watsonpharm.com • Pharmaceutical/biotechnology industry, see “Biotech Beach” • http://www.biospace.com • ACADIA Pharmaceutical • A R Shumway March 2008

31. Biomedical Career Paths • 3. Bio Technology Companies- • “Biotechnology involves the use by industry of recombinant DNA, cell fusion, and new bioprocessing techniques” • Recombinant DNA medicines • Genechip arrays for integrated DNA analysis R Shumway March 2008

32. Medical Industry Career Paths • Bio Technology Companies- • Amgen,Los Angeles,www.amgen.com • Affimetrix, Santa Clara, www.affymetrix.com • LigandPharmaceuticals Inc., San Diego, www.ligand.com • Gen-Probe Incorporated, San Diego, www.gen-probe.com/ • Baxter BioScience Corporation, West Lake Village, www.baxter.com • Pharmaceutical/biotechnology industry, • See “Biotech Beach”-company listing and current biotech job listing at: • http://www.biospace.com R Shumway March 2008

33. Biomedical Career Paths • 4. Clinical Services Companies or Clinical Research Organizations (CROs) • A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. • Pharmaceutical, biotechnology and medical device companies, who call upon Clinical Research Organizations (CRO) resources and expertise to help bring new treatments to patients quickly and safely. R Shumway March 2008

34. Medical Industry Career Paths National Institute of Clinical Research, www.nicresearch.comBeardsworth, www.beardsworth.com Covance , www.covance.com Cato Research Ltd., www.cato.com CroMedica, www.cromedica.com PRA International, www.prainternational.com Inveresk Research Group, www.inveresk.com Medical & Technical Research Associates, www.mtra.com SciAn Research Services, www.scian.com Omnicare Clinical Research, www.omnicarecr.com Synteract, Inc., www.synteract.com TherImmune Research Corporation, www.theimmune.com Quintiles, Inc., www.quintiles.com Association of Clinical Research Organizations, http://www.acrohealth.org/ R Shumway March 2008

35. Biomedical Career Paths 5. Regulatory Compliance US Food and Drug Administration (FDA) – LA District office is in Orange County! 19701 Fairchild, Irvine, CA 92612-2506 Products FDA Regulates: Food Drugs Medical Devices Biologics Animal Feed and Drugs Cosmetics Combination Products Radiation-Emitting Products R Shumway March 2008

36. Biomedical Career Paths Regulatory Compliance http://www.fda.gov/jobs/ US Food and Drug Administration (FDA) – LA District Office, Irvine, CA. Biologist ·Chemist ·Consumer Safety Officer ·Engineer ·Information Technology Specialist ·Medical Officer ·Microbiologist ·Pharmacologist ·Statistician FDA Job Questions? quickquestions@psc.gov Contact Rockville HR Center 1-888-478-4340 R Shumway February 2008

37. Biomedical Career paths Regulatory Affairs Professional Society http://www.raps.org Orange County Regulatory Affairs Discussion Group http://www.ocra-dg.org/ R Shumway March 2008