Management professional: Quality, Regulatory and Product Development

Multi-talented business leader with experience transforming organizations in the realization of products from customer needs through development and product launch with market success. Over the past 20 years, achievements include new products CE marked and class II and III PMA or supplements approved that drive millions of dollars in revenue and sustainable profit growth.

Possess above average understanding of product and process development, validation, Regulatory and Quality systems (QMS) interconnections. Proficient in conflict resolution creating win/ win scenarios to resolve issues while partnering resources to satisfy internal and external customers' needs. Proven new product development strategies and tactical development plans that supported clinical and regulatory risk mitigation for current marketed products and those under development. Responsibilities required the ability to author design history files, design dossiers and 510K filings while interacting at a high level with Federal agency auditors managed across functional and geographic lines within the business.

Executive Management/ Management/Program and Project Management (PMO)/New Product Process Development/ Quality Systems Compliance(CAPA)/ Regulatory Compliance / API process Development/ ANDA/ 505 2b/ Technical Product Support and Process scale-up development/ Verification/ Validation/ Design History Files(DHF)/ Risk Mitigation and FMEA/ New Product Introductions / Design Dossier/ Technical Files/ PMA submission/ 510K submission / CE Mark submission /Medical Device/ Clinical Assay/ Clinical Trials / Market Research/ New Business Development/ Requirements Development / Voice of the Customer Research/ Portfolio Planning / Business Process Development /Statistical process control (SPC)/ Good manufacturing Practices (cGMP)/Design of Experiment (DOE)

Work Experience

MPPGroup, LLC.- Mequon, Wis.

Employment dates: July 2017 to present

Position: VP Quality and Regulatory Affairs

Day to day operational responsibility for the Quality Assurance and Regulatory Affairs Compliance for the organization to ensure current and new market product’s availability due to process or product performance issues.

Key skills, principles and practices

Quality Management System (QMS) architect and executive management oversight for Quality and Regulatory Affairs including: site and systems compliance, registrations, CAPA, NCR, SPC, cGMP & cGLP principles, design verification and validation.

Regulatory strategy development and implementation of day to day Regulatory operations supporting 505 2b, ANDA drug products, class I 510K and nutritional products.

Cytophil, Inc- East Troy, Wis.

Employment dates: October, 2013 to June 2017

Position: Executive Management, May, 2015 – June, 2017

Position: VP Quality and Regulatory Affairs, General Manager: January, 2014 to May, 2015

Day to day operational control for the organization to ensure current market product’s availability due to process or product performance issues leading 15 direct reports across all levels of education including scientists and engineers.

Key skills, principles and practices

QMS architect and management oversight for Quality Management System including systems compliance, CAPA, NCR, SPC, cGMP & cGLP principles, design verification and validation.

Regulatory strategy development and implementation of day to day Regulatory operations supporting class II and class III medical devices including 510K, IDE, PMA and CE Mark applications and approvals.

FDA 483 and warning letter remediation and corrective action resolution through compliance.

Navigated company through challenging balance sheet successfully growing stock value back to PPM levels.

Corporate operational accounting and accountability, fund raising, venture capital screening/Investment

Launched two major products in the $17+ million ENT injectables market in both US and CE marked countries resulting in attainment of 5% market share for each product in first year of launch.

Launched major product in the $1 Billion injectables aesthetics market resulting adding 25% incremental revenue driving and attained first profitable, cash flow positive year in company history in first year of launch.

Established European distribution operations and established sales and marketing presence through network of distributors throughout Europe.

Established Asian presence with network of distributors throughout Asia Pacific.

Built U.S. sales from 0 to 10% revenue in first two years through internal sales force and partnership development.

Merz Aesthetics/ BioForm Medical, Inc.- Franksville, Wis. 53126

Employment dates: September 2003 to 2013

Research and Development and Quality Systems

Position: Director of New Product Development

Director New Product development PMO creating new medical aesthetics products while providing technical process and quality support (re-validation, NCR and CAPA resolution) to ensure current market product’s availability due to process or product performance issues leading 2-4 project managers and/or 6-12 direct reports across all levels of education including scientists and engineers.

Key skills, principles and practices

Design signature authority for Quality System documentation and systems compliance, CAPA, NCR, SPC, cGMP & cGLP principles, design verification and validation.

Working knowledge of standards: ISO 13485, 14971, 10993, 21 CFR 820, 803, 807 and others.

Independent product design developing investigational materials and technologies creating Design History Files (DHF).

Scientific representative participating in Marketing, Medical Affairs and Clinical Education functions including: development of clinical/technical training materials, technical marketing support through published papers and conference presentations and active sampling of physician key opinion leader (KOL’s) for new product development ideas

Research and Development

Position: Director /Manager-Technical Project lead

Independent product design developing bench scale to large-scale manufacturing processes to produce Calcium Hydroxyapatite (CaHA) design creating validation packages and new manufacturing process quality system documentation.

Abbott Laboratories-Diagnostic Division-Abbott Park, Ill. 60060

Employment dates: January 1991 to September 2003

LCx molecular Diagnostic/ Position: Sr. Technical Specialist

Architect Thyroid Assay Development/ Position: Associate Scientist V

Bead Technology and Process improvement Team/ Position: Sr. Product Specialist

Matrix Business Team- Nitrocellulose based immunoassays/ Position: Sr. Product Specialist

Hepatitis Technical Product Development- Bead Technology/ Position: Product Specialist

Vision Quality Control/Position: Quality Control Technician

Key skills, principles and practices

Independent design of experimentation with data analysis developing investigational protocols for new product development and independent process improvement projects.

Independent design and development of validation packages and quality system documentation to support current market products and those under development.

Developing assays formats on prototype and new market instrumentation including large particle, micro particle coating, conjugate/tracer, and calibration strategies

New assay protocol development for Abbott “ARCHITECT” instrument. Scientific/Technical leadership manifested into lead author for patent application in novel T-uptake MEIA assay format.

Implemented cost effective new processing system, which included resin, molding, grinding and outside vendor qualification for new bead commodity validation across ADD commander EIA product Family with market impact to 27 separate assays.

Led collaborations with outside investigative vendors including clinical testing.

Design of Experiment (DOE), Statistical process controls (SPC), Good manufacturing Practices (cGMP).

Project manager covering stability’s administration

Supervisory experience of 1 to 2 supports personnel.

Bell Flavors and Fragrance – Milwaukee, Wis.

Employment dates: January 1989 to January 1991

Position: Technical/Quality Control Technician

Scale up manufacturing process support for pharmaceutical (API- Theophyline) and Caffeine manufacturing.

Instrumentation

GC, GC-MS, HPLC, LC-MS, FTIR, GPC, TLC, SEM, BET, AA, MEIA, EIA, phage display library screening, western blotting, electrophoresis, and phast-gel

Test method development experience with BET, AA, MEIA, EIA, SEM, XRD, GC, HPLC, UV-Vis along with standard USP and FDA standard protocols. Familiarity with manufactures equipment and software: Agilent, HP, Waters, Shimadzu and Varian

Educational Background

Masters in Science-Analytical Chemistry

Marquette University, Milwaukee, Wi.

BA Chemistry/ Emphasis - Biology

Ripon College,

Patents

US 11/083,542, Hubbard, Voigts, Erickson

US 11/528,205, Voigts

US 11/348,028, Voigts

US 11/650,696 CIP, Voigts, Devore

WO 2008/088381 A2, Voigts, DeVore

US 61/660,269, Friedrick, Barg, Voigts, Ligman

Regulatory Approvals

Authored: US 510K 150400- Approved

Authored: CE Mark Class III design dossier 630688 -Approved

Authored: CE Mark Class III design dossier 668767 - Pending

Publications

COLEMAN, KYLE M., VOIGTS, ROBERT, DEVORE, DALE P., TERMIN, PAUL, COLEMAN III, WILLIAM P., Neocollagenesis after Injection of Calcium Hydroxylapatite Composition in a Canine Model ; Dermatologic Surgery, Volume 34, Supplement 1, June 2008, pp. S53-S55(1)

BUSSO, MARIANO; VOIGTS, ROBERT ; An Investigation of Changes in Physical Properties of Injectable Calcium Hydroxylapatite in a Carrier Gel When Mixed with Lidocaine and with Lidocaine/Epinephrine; Dermatologic Surgery, Volume 34, Supplement 1, June 2008, pp. S16-S24(1)

ROBERT VOIGTS, DALE P. DEVORE, JON M. GRAZER ; Dispersion of Calcium Hydroxylapatite Accumulations in the Skin: Animal Studies and Clinical Practices; Dermatologic Surgery, Volume 36, Issue 0, May 2010, Pages: 798-803

WEISS, ROBERT A. MD, VOIGTS, ROBERT MS., HOWELL, DAVID J. PHD; Absence of Concentration Congruity in Six Compounded Polidocanol Samples Obtained for Leg Sclerotherapy.Dermatol Surg 2011;37:1–4

SUNDARAM, HEMA MD, VOIGTS, BOB MS., BEER, KENNETH MD, MELAND, MELISSA BS;

Comparison of the Rheological Properties of Viscosity and Elasticity in Two Categories of Soft Tissue Fillers: Calcium Hydroxylapatite and Hyaluronic Acid. Dermatol Surg 2010;36:1859–1865

ROBERT VOIGTS; "Volumizing characteristics of dermal fillers"- Poster, Biomaterials 2011 Annual Meeting and Exposition

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