PDA Capital Area Chapter

Chapter Officers

• 
  Martin Jenkins

  President/Senior Consultant

  President

  Circle MJ Consulting

  [email protected]

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  Martin Jenkins, PMP has over 25 years of experience leading equipment and facility qualifications, technology development and transfers, as well as leading projects and programs in the pharmaceutical, biotechnology, and life science industries. He is currently the Senior Project Manager for Qualification and Validation at Circle MJ Consulting. Martin is also the President of the Capital Area Chapter of the PDA. Martin’s experiences include working with CGMP products such as API drugs, bulk pharmaceuticals, medical devices, sterile injectables, customized cell culture products, enzymes, amino acids, proteins, chemicals, animal health and agricultural products in the areas of analytical chemistry, molecular biology, microbiology, forensics, veterinary, and entomology. This includes processes such as drug and device manufacturing, cleaning, environmental monitoring, spray drying, packaging, utility qualification, facility commissioning, labelling, product design, laboratory and assay testing.

  Martin is well versed in Validation, Quality Initiatives, Quality Assurance and Regulatory Affairs, R&D, Process Analytical Technology, Manufacturing Operations, Commissioning, Remediation, ALCOA+ Documentation Principles, Program Leadership, Project Management, Team Development, Design for Six Sigma, CGDP, Risk Assessment, DMAIC Six Sigma, Lean, Process Analysis, and Lab Management. He is skilled also in leading multi-site level projects with small and large teams.

• 
  Krystian Gonzalez-Vasquez

  President-Elect

• 
  Stephanie Brandford

  Secretary

  Brayearst Validation Consulting

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  Stephanie is a Carnegie Mellon chemical engineering graduate with a passion for optimization and compliance. Her career began in the chemical industry, where she focused on environmental regulations and leveraged statistical process control to enhance manufacturing processes, driving efficiency and sustainability.

  Transitioning to the medical device industry, Stephanie brought these principles into the highly regulated realm of FDA standards. She dedicated herself to ensuring the safety and reliability of life-saving products, earning her Six Sigma Black Belt certification and taking on a leadership role in validation engineering. Over the past decade, she has conducted peer reviews of validation packages, identifying compliance gaps and areas for improvement. In addition, Stephanie has spent 12 years designing and delivering training programs, equipping professionals with expertise in validation and Six Sigma methodologies.

  As the founder of Brayearst Validation Consulting, Stephanie leads a company dedicated to implementing Six Sigma methodologies across validation projects, training programs, and spot check services. With a deep understanding of Life Sciences products and processes, Brayearst produces robust validation documentation designed to meet stringent regulatory standards and audit requirements. Stephanie’s work reflects her unwavering commitment to precision, compliance, and advancing industry standards.

• 
  Ben Bhattarai

  Treasurer