Michael Kochersperger, CRES

Experience

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  Applied Biosystems, Inc.

  Jan 1984 - Jan 2000

  Program Manager, Combinatorial Chemistry Synthesis System Research & Development

  Responsible for leading 40 member multi-disciplinary, multi-national cross-functional product development teams to develop robotic combinatorial synthesizer from concept to commercialization. Responsible for a $7.2 million budget to design, develop, ensure regulatory certification, and production scale-up within ISO 9001 facility. Selected and interacted with OEM component suppliers and contract design firms.Other significant contributions during 16+ year tenure: Mass Spectrometer Product Marketing Protein Sequencing Research & Development Capillary HPLC systems: PTH-Amino Acid protein purification R&D Protein Sequencing Field Service Specialist Show less

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  Orchid Biosciences, Inc.

  Jan 2000 - Jan 2003

  Director of SNP-IT High Throughput Genotyping Product Development

  Lead 15 member R&D and engineering team to design, development and commercialization ultra-high throughput micro-array imaging platforms to detect Single-Nucleotide Polymorphism (SNPs). • Managed $4 million program: worked with internal and external partners to define SNP product specifications.• Conducted Voice-of-the Customer marketing campaigns to determine key product requirements.• Translated requirements to formal specification as basis for product development program.• Co-PI for large DARPA grant to synthesize high quantities of single stranded DNA fragments in micro-fluidic synthesis system. Show less

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  New Brunswick Scientific, an Eppendorf Company

  Jan 2003 - Jan 2008

  Vice President of Engineering

  Responsible for leading strategic global product development programs, 40+ direct and indirect reports, liaised with manufacturing, sales, marketing and service teams to increase product competitiveness, reduce cost and implement product development process worldwide. Reported directly to CEO and aligned created and executed strategic plans to meet corporate goals and objectives.• Reduced product portfolio costs: standardized product designs to reduce complexing and number of inventory SKUs.• A $1.2M cost reduction yielding 9% profit margin improvement.• Expanded product portfolio in all offering categories: identified gaps in product lines and worked with marketing and sales to close them.• Standardized product development processes: implemented same 3D CAD tools across global design/development teams.• Increased departmental efficiency and resource utilization resulting in 13% productivity improvement.• Reduced Engineering department costs by 19%.• Accelerated product time-to-market by 31% yielding marketplace competitive advantage.• Worked with manufacturing teams to adopt/adapt preventative manufacturing measures to improve process/product reliability/quality. Show less

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  BioNano Genomics, Inc. (formerly BioNanomatrix, Inc.)

  Jan 2008 - Oct 2010

  Vice President of Engineering

  Responsible for leading day-to-day operations, R&D, engineering, production, and manufacture of single molecule fluorescent imaging platforms comprised of hardware, software, electronics and reagent kits. Reported directly to CEO responsible for providing updates to board of directors, Senior Management and involved with presentation to potential investors.• Reduced production costs: revised proprietary consumable design to reduce cost by 17% and 5X increase in volume.• Increased company valuation: deployed early adopter systems at KOL sites resulting in $23.3MM venture capital investment. Show less

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  MLK Consulting

  Jul 2011 - Nov 2012

  Principal

  Akonni Biosystems, Inc.• Established QMS product development program: created, established and implemented a quality management system compliant with FDA 21 CFR 820 and ISO 13485 product development requirements.• Drafted SOPs and trained personnel on procedures/processes.• Implemented Phase Gate product development procedure to standardize development process and manage change control.• Worked with manufacturing team to implement cGMP processes and manage materials flow.QLIDA Diagnostics, Inc.,• Responsible for day-to-day operations: worked with R&D to develop product specifications, manage workflow, review product development progress, present technology to potential investors.• Constructed prototype imaging platforms to show proof-of-principle.• Created hand-held mobile imager design for POC application and deployment in EMT settings.• Worked with biochemists to improve robustness of immune-assay and imaging platform to meet product specifications.PharmaSeq, Inc.,• Implemented QMS programs: tailored flexible QMS program to meet company business requirements.• Established Phase Gate product development program: created product development processes that support FDA 21 CFR 820 and ISO 13485 compliance for medical device products.• Lead Clinical Trial preparation for Cystic Fibrosis study: interfaced with clinical trial consultants, IRB panel and Senior Management to prepare for human cystic fibrosis biomarker studies. Show less

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  Compliance Architects® LLC

  Dec 2012 - Dec 2013

  Senior Medical Device Product Consultant

  SME assigned to Johnson & Johnson Consumer Healthcare, Skillman NJ provided design control, quality compliance, risk management and manufacturing (cGMP) support to engineered, formulated and combination Medical Devices product teams.• Drafted Corporate Global Quality Playbook: worked with quality team to write global quality playbook to standardize and integrate quality processes across entire organization.• Lead quality system team to draft baseline quality system standardizing product development processes and incorporate FDA combination medical device requirements.• Remediated Medical Device Design History Files: reviewed Design History files for FDA 21 CFR 820 compliance.• Worked with project team to resolve identified compliance gaps in product development process.• SME supporting project team to update multiple Design History Files into compliance.• Involved in CAPA activities for product, processes and related issues. • Subject matter expert for product development, change control, risk management and manufacturing process verification/validation. • Provided SME support for product development, change control and risk management process reviews during audits.• Improved Robustness of Product Development Processes: standardized product development process across entire organization.• Restructured product development processes to improve efficiency and effectiveness.• Updated SOPs to incorporate new process structure to incorporate combination medical device requirements.• Provided Support During FDA Audits: helped prepare and support FDA on-site audits of product development processes.• Provided support to operations/manufacturing during process validation efforts at North American production sites. Show less

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  NetScientific America (Subsidiary of NETSCIENTIFIC plc)

  Jan 2014 - Jul 2016

  VP Global Engineering

  VP Global EngineeringNETSCIENTIFIC, AMERICA (Subsidiary NETSCIENTIFIC plc London England) Jan. 2014 – July 2016Transatlantic healthcare/medical device group which funds and develops companies that have transformative technologies with potential to significantly improve the health and well-being of people with chronic diseases.Provide global company portfolio teams with systems engineering, quality, compliance, regulatory certification and commercialization expertise to facilitate product design, development and commercialization efforts. Guide portfolio companies through transfer-to-manufacturing, production scale-up and product launch processes. Support business development, collaborations and partnerships within areas of interest to enhance growth and increase portfolio value. Mentored NetScientific portfolio companies regarding product commercialization. Conducted due diligence of potential technologies for inclusion in portfolio.CTO & VP of EngineeringVORTEX BIOSCIENCES, INC. (Menlo Park, CA) NetScientific plc Portfolio CompanyAssembled and led diverse internal and external cross-functional teams to develop and commercialize transformative circulating tumor cell (CTC) Class I & II medical device platforms. Assembled team to establish and implement engineering, quality, compliance, regulatory product certification and commercialization of diagnostic medical device systems within start-up environment. Created and maintained relationships with key contract design, development and manufacturing partners through all stages of product lifecycle. Heavily involved with regulatory certification, transfer-to-manufacturing, production scale-up and product launch planning. Provided support to strategic collaborators and partners. Participated on the European Biopharmaceutical Enterprises steering committee for Antibody Drug Conjugates and engaged regulators to discuss proposed solutions and share outcomes with broader stakeholder community. Show less

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  MLK Consulting Services LLC

  Jul 2016 - now

  Principal

  Global Cultural Team Integration | Strategic/Tactical Business Unit Development & Execution Medical Device Development Engineer with exemplar reputation for combination product development team leadership from concept through manufacturing and commercial transfer.Extensive experience identifying and mobilizing top-tier talent to create high performance cultures within dynamic work environments consistently achieving corporate objectives. Strategic/Tactical Business Planning and Execution Seamless Process Integration Across Organization Change Management Advocate Asian, European, ROW Global Expertise Proactive Collaborative Approachability Cross-cultural Talent Training and Development Key Supplier Relationship Management 21 CFR 820, ISO 13485, ISO 14971, ISO 10993 European MDD, CE-IVD  21 CFR part 4 cGMP Requirements Risk Management and Compliance Intellectual Property Management/FTO Proactive KPI Management Budgetary Accountability Management Show less

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  AXA Advisors, LLC

  May 2018 - Jan 2019

  Financial Consultant CA Life Insurance License #: 0M52926

  AXA Advisors, LLC is a team of financial professionals who take a “holistic human approach” to helping our clients safeguard their families’ finances and plan for their futures throughout all stages of their lives and careers. Our commitment to helping our clients define who we are and help them reach their financial goals is an obligation that we take very seriously.We help people accumulate and protect wealth via a comprehensive holistic planning approach. Our approach allows us to serve all of our clients' needs, from asset management, retirement and estate planning, life insurance, long term care and disability insurance. We create comprehensive strategies for employers and business owners to establish 403(b) /401(k) /457 plans, executive compensation and employee benefit programs including health and retirement. We customize strategies for our clients, then offer products from hundreds of investment and insurance companies.AXA Financial Advisors are results-driven, highly motivated professionals who have the desire to help others grow, attain and protect their financial futures. We have a very successful wealth management team and are looking forward to helping you reach your financial goals.AXA Advisors, LLC (NY, NY 212-314-4600), member FINRA, SIPC. Equal Opportunity Employer—M/F/D/V. Important information & Disclosures: http://bit.ly/2f98X9d Show less

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  GWN Securities, Inc.

  Jan 2019 - now

  Financial Advisor

  CA Life Insurance License #: 0M52926

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  MLK Consulting Services, LLC

  May 2020 - now

  Principal

  Supporting NIH Rapid Acceleration of Diagnostics (RADX®) https://www.nih.gov/research-training/medical-research-initiatives/radxNIH Rapid Acceleration of Diagnostics (RADX®) Project Facilitator May 2020 – PresentAs Project Facilitator for multiple RADx® projects coordinated interactions across team/entity, project team, and other resources to rapidly bring innovative approaches and technologies for COVID-19 testing to fruition. As experienced SME medical device product design, development, commercialization and extensive quality management systems expertise providing support to project teams and Team Lead(s). Managed team and resource interactions through coordination of meeting schedules, monitored and tracked project progress, updated project status and progress in GAITS site. Prepared decision point meeting presentations for Team Lead(s). Show less