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

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slide1

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

slide2

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

slide3

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
slide4

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

the three types of heart valves
The Three Types of Heart Valves

Bovine Pericardial Valve

Mechanical Heart Valve

Porcine Heart Valve

slide6
PERIMOUNT Magna

Model 3000

PERIMOUNT RSR

Model 2800

No Cuff = Theoretically Better Laminar Flow through Valve

slide8

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

slide9

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

iii 7 key tactical recommendations to jump start your career
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!
slide11
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
slide12
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
slide13
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
slide14
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
career fairs
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.
slide16
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!
slide17

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

slide18

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

slide19

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

slide20

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

slide21

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

slide22

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

slide23

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

slide24

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

slide25

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

slide26

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

slide27

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

slide28

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

slide29

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

slide30

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

slide31

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

slide32

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

slide33

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

slide34

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

slide35

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

slide36

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? [email protected]

Contact Rockville HR Center 1-888-478-4340

R Shumway

February 2008

slide37

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

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