PDA Capital Area Chapter

Chapter Officers

• 
  Martin Jenkins

  President/Senior Consultant

  President

  Circle MJ Consulting

  martinjenkinspmp@comcast.net

  Read Bio

  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.

• 
  Sapan Patel

  Associate Director, Quality Assurance

  Treasurer

  AstraZeneca

  Read Bio

  Sapan Patel is a seasoned quality assurance leader with extensive expertise in the pharmaceutical and biopharmaceutical sectors, currently positioned as Associate Director QA at AstraZeneca. Fluent in multiple languages including Hindi, Gujarati, English, and Spanish, he brings a multicultural and inclusive perspective to his leadership roles. Based in Gaithersburg, Maryland, Sapan has demonstrated a robust ability to lead quality initiatives across various operational and strategic levels.

  Holding a Master of Science in Pharmaceutical Manufacturing from Stevens Institute of Technology and a Bachelor of Science in Pharmacy from Rajiv Gandhi University of Health Sciences, Sapan has developed a solid foundation in drug development and manufacturing. His career includes significant stints at MilliporeSigma and MedImmune, where he led numerous quality improvement projects, demonstrating his capabilities in cross-functional team leadership and regulatory compliance.

  Sapan's professional skills are vast, encompassing regulatory affairs, process validation, cleaning validation, and a proficiency in using Minitab for statistical analysis. His core areas of expertise include talent development, process transfer, scale-up initiatives, and process improvement, with a strong emphasis on employing Quality Risk Management (QRM) to make informed, risk-based decisions.

  At AstraZeneca, Sapan has been instrumental in enhancing product quality leadership, focusing on strategic quality decision-making and improvement. His leadership extends to teaching and mentoring, preparing the next generation of quality professionals for future challenges in the industry.

• 
  Julie Barnhill

  Senior Consultant

  Secretary

  Meridian BioGroup

  Read Bio

  Julie Barnhill is a dynamic and results-driven professional based in Baltimore, Maryland, currently serving as a Senior Consultant with Meridian BioGroup - Pace® Life Sciences. With over 20 years of experience in the biopharmaceutical sector, she excels in designing, implementing, and managing compliance and quality systems. Her expertise is deeply rooted in FDA and DEA regulatory standards, having successfully managed numerous regulatory inspections.

  
  

  Dr. Barnhill's journey in the biotechnology field is fortified by an extensive educational background, holding a PhD in Biochemistry from the University of Pennsylvania, complemented by a Bachelor of Science in Chemistry from Trinity College-Hartford. Her academic prowess led her to teach in the graduate Biotechnology program at Johns Hopkins University, sharing her knowledge and experience with aspiring professionals.

  
  

  Previously, Julie held significant roles at Osiris Therapeutics as Senior Manager of Quality Systems and at Actavis (formerly Alpharma Pharmaceuticals) as a QA Compliance Manager. Her career also includes a tenure at Charles River Laboratories as Senior Manager of Process Development and at Chesapeake Biological Labs as Director of Quality Control. In these positions, she led critical initiatives ranging from process development for clinical phase biologics to overseeing quality control for both clinical and commercial products.

  
  

  Julie's specialties encompass a broad spectrum, including cGMP, GTP, GCP, GLP, FDA compliance, quality systems, and quality auditing. At Meridian BioGroup, she continues to leverage her skills in auditing and consulting to enhance client engagements and ensure stringent compliance with global regulatory authorities.