Experience

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  Kenvue

  • Ann Arbor, Michigan, United States

  • Senior Scientist Global Validation

    • May 2023 - Present
    • Ann Arbor, Michigan, United States

    Global Process Owner of Continued Process Verification, Validation Master Plan and Process Validation of Drug Products.

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  Penny Black Stamp Company

  • Dexter, Michigan

  • Owner and Operator

    • Aug 1985 - Present
    • Dexter, Michigan

    The Penny Black Stamp Company was founded in 1912 by my father, Sam L. Bayer in Europe. During his life in Europe my father created early airmail and zeppelin flight covers. Today these covers are sought by philatelic collectors all over the world. The Penny Black Stamp Company specializes exclusively in Vatican City philatelic material. For almost 100 years the Penny Black Stamp Company has been synonymous with quality in the philatelic world. We specialize in Vatican City, past as well as new issues. Our new issue service is complete. We offer fast friendly service at prices that are competitive or better.

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  Johnson & Johnson

  • Ann Arbor, Michigan

  • Principal Scientist, Global CPV Program

    • Jan 2018 - May 2023
    • Ann Arbor, Michigan

    Continued Process Verification (CPV) is a lifecycle element of the validation program for drug products and an FDA and EMA 2015 Annex 15 regulatory requirement for all drug products. The goal of CPV is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. I am responsible for the development and implementation of CPV into all global JNJ consumer family of companies sites. I lead strategic activities and projects related to the global implementation of the processes and systems related to the ability to effectively identify, detect and respond to product performance variation deviating from the intended validated state in a diverse, global drug product portfolio.

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  Pharma Resource Group, Inc.

  • Fort Washington, PA

  • Senior Process Scientist at McNeil

    • Aug 2011 - Dec 2017
    • Fort Washington, PA

    Facilitate site transfer and technical support for approximately $2B of products at an external facility in EU. Manage all project functions, including strategy development, milestones, and reporting. Ensure regulatory compliance. Analyze Annual Product Review. • Completed site transfer of 8 products (worth $2B), including design and execution of Development & Validation studies.• Developed Continued Process Validation (CPV) program for multiple products at multiple international sites. • Reduced manufacturing time from 7-eight hour shifts to 3-eight hour shifts by implementing process improvements for major OTC product.• Recovered over $2M in product annually slated for disposal by developing and executing product support studies.

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  Merial

  • Senior Process Scientist II

    • Sep 2010 - Aug 2011

    Provide technical leadership in designing and conducting scientific experiments for process development, optimization, scale-up and technology transfer activities leading to the attainment of short and long-range objectives. Provide technical support and guidance in designing and performing simple to complex experimental studies to identify and optimize critical process parameters and define their optimal ranges for the development of robust manufacturing processes for novel and line extension veterinary pharmaceutical products. Provide a lead role as technical liaison with multidisciplinary R&D groups and global manufacturing sites.

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  Pfizer

  • Research Scientist

    • Oct 2002 - Dec 2008

    Developed systems to schedule and expedite manufacture of clinical materials, and troubleshoot as needed. Supervise the production of clinical supplies in-house and at third-party contractors. Recommended equipment and processes for new GMP manufacturing facility. Issued all required documentation, including Master and Working Batch Records, and Formulations Summaries for proper clinical supplies manufacture. Performed deviation investigations as needed and issued reports and CAPAs.Project management responsibilities across multiple functional areas, coordinating all project communications and details. Extensive experience as liaison with executives, researchers, vendors, and technicians, as well as internal Development and Production departments. ACCOMPLISHMENTS INCLUDE:•Multiple “Individual Performance Awards” for excellence.•Member of Co-Development Team. Assisted with scale-up and launch of Phase III clinical materials.•Member of Phase I Dosage Team. Saved time and money by Investigating new methods to produce Phase I clinical supplies in timely manner with limited formulation development and use of limited API.•Annual Performance Reviews: consistently “Exceed Expectations”.•Perfect Record: have never caused delay of a clinical study.-Perfect attendance for 6 years

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  Quintiles Transnational

  • Group Leader - Formulations

    • Dec 1998 - Oct 2002

    •Liaison with clients, including estimating costs and timing of requests as well as technical feedback on projects. Developed formulations for new solid dosage products including; tablets, capsules and film coating.•Design and performed process development studies for introduction of Phase III manufacture of high potency product into commercial manufacturing.•Issued all required documentation, including Master and Working Batch Records, and Formulations Summaries for proper manufacture. •Authored CMC section of IND and NDA applications.•Project management responsibilities across multiple functional areas, coordinating all project communications and details. •Led group of formulator and technicians, performing annual reviews, training and development of staff.

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  Hoechst Marion Roussel

  • Group Leader - Clinical Supplies Manufacturing

    • Jul 1996 - Dec 1998

    • Issued all required documentation, including Batch Records, and Formulations Summaries for proper clinical supplies manufacture. •Led successful commercial site transfer of solid dosage product. Successfully defended NDA applications during FDA pre-approval inspections. • Issued Process Development and Engineering Reports summarizing SUPAC site transfer of product into local commercial manufacturing. These reports were reviewed by FDA during inspection resulting in successful inspection.• Led team of scientist and technicians issuing reviews, promotions, training and scheduled work to maintain acceptable workload.

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  Hoechst-Roussel Pharmaceutical Incorporated

  • Research Scientist - Process Develoment

    • 1987 - 1996

    •Developed and qualified new liquid and semi-solid projects into full-scale commercial production while investigating and justifying each critical production step using good scientific reasoning. •Introduced new semi-solid filling equipment into commercial packaging. Also qualified new cleaning and packaging procedures, and trained operators.•Created Batch Records, and processed development reports and other documentation necessary for CMC section on NDA and NADA applications.•Successfully defended multiple projects during FDA Pre-Approval Inspection resulting in product launch.•Manufactured clinical supplies for Phase II through Phase IV Studies.

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  International Playtex Inc. - Max Factor division

  • Scientist - Liquid Formualtions

    • Apr 1984 - Jan 1987

    •Formulated new emulsion make-up (mascara and liquid make-up) and scale-up into commercial production.•Color scientist matching required shades of mascara and liquid make-up. •Approved new standards for transition into commercial manufacturing.•Worked with third party nail lacquer manufacturers to develop new shades of products and review manufacturing records.

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  Revlon

  • Formulation Chemist - Emulsions

    • Apr 1983 - Apr 1984

    •Developed emulsion make-up (mascara and liquid make-up) and pressed powder make-up •Developed process to increase unacceptable viscosity of mascara batches, thus saving the batches for sale.•Matched shade of mascara and liquid make-up for successful introduction into market.