Professional consultants in our company are passionate about the best interest of the patient. We provide quality, long term solution options to our clients, as well as provide guidance to companies and organizations, to meet and exceed regulations. There is no singular formulaic – each companies’ needs are unique.

Michelleanne, President and CEO of Metis, has over 20 years of experience in the biotech and pharma industry with a focus in the quality and pharmacovigilance sector.

She founded Metis because she wanted to lead the kind of company that did not exist in the corporate America that she experienced. She believes that the corporate landscape is changing and we have a long way to go. Her role constantly asks how she can build the type of company that she is proud of, a new kind of corporate organization that is needed today.

Her forte is interdepartmental alignment and maximization of services within an organization, and specializes in the Quality and Pharmacovigilance spaces. She takes pride in bringing teams together to work in harmony towards a common goal. Using her knowledge and experience, she enjoys helping companies identify their deficiencies and turn them into opportunities for success and growth. Her leadership philosophy is that a company does not have to be perfect but must have grace for the process and those involved, especially employees. She works hard to provide space where all team members can thrive.

Ethics is her passion.

Jennifer has over 25 years in the Quality and Compliance area through the entire product life cycle. Her specialty is with post marketing activities, e.g. Pharmacovigilance, HCP Engagement, and Commercial. She has harmonized and developed processes that are simple and sustainable as companies grow organically, as well as through mergers and acquisitions. Jennifer has participated and led dozens of health authority inspections in various countries worldwide, most of which resulted in minimal observations or no 483. One of Jennifer’s most rewarding professional moments was leading her company’s project to implement the initial release of the EMA’s GVP modules in 2012. As part of that project, Jennifer designed the PSMF which was the first one accepted by the EMA. During an inspection, MHRA inspectors suggested that it be used as the model for the industry. She currently is a co-host on Metis Consulting Services podcast, Queens of Quality.

Michelle Maddox comes to Metis with over 20 years of experience in finance and systems from retail to healthcare. Her breadth of knowledge and management skills are critical for Metis to maintain its reputation as a premier Biotech and Pharmaceutical consulting firm. She believes that what is most important in life is family in all its forms, which is in line with our own philosophy and mission statement at Metis. The end result of any pharmaceutical testing is to bring to market a product that enriches the quality of life with family, and her voice is that reminder to our team every day.

Dr. Lambert has 20+ years of experience in drug and device development. His experience includes device/drug combination products, vaccines, monoclonal antibodies, recombinant proteins, peptides, and small molecules for parenteral, pulmonary, solid oral, topical, and transdermal dosage forms. He has expertise in Quality by Design with a specific emphasis on designing and leading Risk-Based QBD activities for ANDA, NDA, BLA, PMA, and MDD applications. He has executive leadership experience and expertise in CMC strategies for small, large, and complex large molecule modalities and in developing, formulations, processes (upstream and downstream), and analytical methods for products at all phases of drug and device development lifecycle.

Dr.Lambert’s participation in academic/industry/regulatory agency collaborations throughout his career has resulted in multiple grant awards supporting the development of novel products and therapeutics. He has unique experience in having supported both development and commercial manufacturing on the drug/product sponsor side of the development process, as well as from a contract service provider’s perspective. He continues to apply his industry knowledge and thought leadership to support innovative market approvals for novel technologies.

He enjoys gardening and skiing with his family.

Area of Expertise: Regulatory Strategy

Dr. Olivia Fletcher has a passion for laws and regulations. She has spent the bulk of her career working in and around the legal field in some capacity, from patent prosecution to government contract management. She received her doctorate in forensic psychology, where she fell in love with statistics and data analysis. She was trained as an expert witness and did industrial and organizational psychology and risk management coursework. Dr. Fletcher has earned a Regulatory Compliance certificate from the University of Pennsylvania Law School and has completed coursework in Drug Development and Commercialization at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California, San Diego. She has a personal goal of visiting every one of the USA’s national parks and has been to roughly ¼ of them.

Area of  Speciality: Program Manager/ Specialty Area Data and Statistics

Roshini is a highly experienced professional with a strong patient service and PV operations background. With a master’s degree in physical therapy and 26 years of experience in the healthcare area (academic and PV operations), she has developed a deep understanding of healthcare operations and the importance of delivering exceptional patient safety service.

She served as a lecturer for 11 years, sharing her knowledge and expertise with aspiring physical therapists. This experience helped develop communication and leadership skills, allowing her to effectively convey complex concepts and guide others in their professional development.

She has 15+ years of PV experience (training and operations). Throughout her career, she has gained extensive project management experience, successfully oversaw vendors, and ensured regulatory compliance. She has a proven track record of implementing innovative strategies and streamlining processes to enhance the overall operational efficiency, quality, and compliance in PV operations. Roshini also loves to cook and experiment with new cuisines. She is also a rookie gardener who believes she has killed more plants than she has grown.

Scott is a business development and marketing specialist with over 20 years of experience building strategic relationships.He has a proven track record of success in developing client solutions over his career for Fortune 500 Companies, small to medium organizations and his own small business. Scott has a BA from Curry College in Milton MA.

Robert Hernandez has been working in manufacturing (Biotech, Machine Shop, Pharma, Medical Device) for over 16 years. Starting in Materials Management, he eventually worked his way into Supply Chain and Logistics, which included Inventory Control, Scheduling, and Purchasing. His educational background includes certifications in Accounting and Supply Chain Management. He is currently pursuing a degree in Supply Chain/Program Management in the Spring of 2024.

While not working, Robert enjoys reading, working out, trying new recipes, hiking, spending time with his family, gaming, and trying new eateries. He is something of a cinephile and melophile, enjoying a wide range of films and music.

Dornan McGuire has over 25 years of human resources experience within a variety of companies across multiple industries, including blue-chip financial services and technology leaders and startups, to support organic growth as well as M&A activity. She is a trusted resource for developing and executing initiatives that support Metis’s organizational strategy. On any given day, Dornan may advise us on a multitude of people issues, including employment law, talent acquisition, employee experience, compensation, and benefits, and learning and organization development and capacity. Dornan graduated magna cum laude from Regis University, with a degree in Human Resource Management and Organization Development. She is also a proud US Navy veteran and mother to two wonderful, grown boys (men!). In her spare time, Dornan enjoys traveling (she is a true Francophile), hiking, and spending time outdoors with friends and family.

Li-Anne specializes in communication and research, supporting her colleagues on new projects and document support. as well as Social Media and outreach. She is a firm believer in bringing positivity to the workplace, the human touch of empathy, and patience. She supports teams’ projects, provides the resources and the insight they need promptly, and believes in the power of knowledge discovery. No new learning is ever wasted. She appreciates that her Metis colleagues never lose sight of the patient as the top priority.

Li-Anne enjoys storytelling for Children and Adults and teaches college students and others how to tell their stories. She has a profound interest in all things Celtic stemming from the part of her varied heritage that started in Scotland and Ireland. Ballads, Stories, drums, and bagpipes are always welcome. Her deep love of all things Celtic also has her teaching a whisky class and tasting as a once-a-year fund-raiser.