Boasting a wealth of experience from her 15+ years spent in traditional pharmaceuticals and R&D, Dr. Andrea Winslow now serves as BSC Group’s lead Analytical Chemist. With a BA in Chemistry from Wesleyan University, and a Ph.D. in Organic Chemistry from University of Miami, Dr. Winslow has held noteworthy positions of leadership for Janssen Pharmaceutica, R.W. Johnson and McNeil Consumer Healthcare.
Andrea’s background, intellect, organization skills, and ability to deliver project milestones on time, on budget and within scope make her an ideal partner to oversee the buildout of cannabis lab facilities, including the workflow, equipment sourcing and SOPs for analytical testing labs. She is an invaluable resource for labs or extraction facilities looking to implement cGMO/cGLP testing, validation, or quality analysis / control procedures. She adds tremendous value to MIP / Manufacturers who are looking to formulate new product lines, explore new infusion techniques, innovate new delivery methods, or solve issues surrounding shelf life, stability, and batch consistency.
With a track record of consistency and regulatory prowess, Andrea is the perfect asset to any company pioneering pathways through an emerging market, who may require collaborative assistance with government oversight committees and agencies in order to establish understanding and gain approval. For multistate licensees, she is a more than competent change manager to align parallel processes and procedures.
As Senior Scientist of Quality Assurance for Janssen Pharmaceutica in 1999, Andrea project managed and implemented Near Infrared technology, and coordinated its alignment between Johnson & Johnson manufacturing sites. As part of this implementation, she developed, validated, implemented and provided training classes for the new NIR technology. She even went as far as creating and co-chairing the First International Johnson & Johnson NIR Symposium.
In 2001, as Senior Scientist of Drug Evaluation for R.W. Johnson, Andrea evaluated drug substances and products for their development potential, developed analytical test methods and impurity profiles, identified impurities and degradation products (LC/MS, synthesis, UV-Vis, NMR), and performed solid state form characterization of drug substances ( IR, Raman, X-ray ).She was an instrumental part of the team that developed a standardized, high throughput, drug polymorph screening process for active pharmaceutical ingredients.
Shortly after, Andrea rejoined Janssen Pharmaceutica. This time she applied analytical techniques to QA and manufacturing functions and conducted product investigations for several brand name pharmaceuticals, including Ortho Evra and Nizoral. During this time, she also designed, planned and set-up a synthesis lab within the QA department. She was able to use this lab to synthesize degradation products for positive confirmation, and resolved investigations using advanced lab techniques.
In 2003, McNeil Consumer Healthcare benefited from having Andrea on board as their Team Leader for Analytical R&D. She spent just under 2 years in this role, working on projects supporting Pepcid AC, Tylenol Rapid Release Gels, Motrin, Imodium, Mylicon and Pancreaze brands. She also managed the analytics of development from pre-formulation testing through product launch, and coordinated analytical testing for NDA filings, all the while managing a team of up to 30 professionals to qualify new manufacturing areas and reformulate products. Here she met aggressive timelines while ensuring cGMP and cGLP compliance for NDA filings, selected contract testing sites for high volume projects and performed due diligence to confirm the quality of the work for internal stakeholders.
From 2005 to 2017, Dr. Winslow served as Manager of Analytical R&D/QA for McNeil Consumer Healthcare (currently known as Johnson & Johnson Consumer Inc). Here, her profound list of responsibilities included managing cross functional teams for product launches, manufacturing resitings, process improvements, technical transfers, and analytical method development, validation and transfers. She consistently achieved project-specific goals on individual and team deliverables, working collaboratively within a matrix environment. Most of these projects made the president’s annual top 10 list.
Andrea developed and maintained relationships on cross-functional project teams which included Marketing, Medical Affairs, Regulatory Affairs, Project Management, Formulators, Operations and QA/QC. She prepared and critiqued CMC documents for NDA and sNDA filings, managed the developmental stability testing program supporting product shelf-life expiry, and was accountable for making sure hergroup followed FDA, cGMP and cGLP guidelines. Her group also developed new analytical test methods and qualified new testing sites.
As part of the acquisition of Pfizer Consumer Healthcare products, Dr. Winslow and her group successfully integrated and developed analytical methods for incorporating these products into the McNeil Consumer Healthcare portfolio. (Key products included Zyrtec, the Sudafed family of products and Rolaids.) She was also responsible for developing strategic initiatives to ensure cGMP and cGLP compliance while successfully and seamlessly transitioning to new processes. As a means to this end, she developed project teams by fostering peer collaboration, making everyone accountable to each other and ensuring timely, well vetted project completion. As a result she was recognized as the McNeil Project Team of the Month by the leadership board for going above and beyond to keep project timeline promises.
Andrea’s tireless efforts deservingly led to her receipt of J&J’s Lightning Strikes Individual Service Awards, Encore Awards and Global Standards of Leadership Awards, including a North America and OTC Consumer Eagle Award. In addition to being the author of numerous publications and a former director-at-large for the Greater Philadelphia Healthcare Businesswomen’s Association, she has also served as Treasurer, Vice-Chairperson, and Chairperson for the Johnson & Johnson Corporate Analytical Subcommittee.
We could not be more pleased to offer Andrea’s impressive expertise as an extension of BSC’s application, consulting, management, and product-development services.