Shawn Kinney, Ph.D.

Chief Executive Officer

Dr. Kinney is a seasoned chief executive with a technical background and more than 30 years of experience in sterile drug manufacturing and filling of vials, pre-filled syringes and custom containers.

Prior to establishing Berkshire Sterile Manufacturing, Inc. (BSM) in 2014, Dr. Kinney was the Founder and CEO of Hyaluron, Inc. Hyaluron was a contract manufacturer providing aseptic manufacturing and filling services to the pharmaceutical, biotech and medical device industries which was sold to AMRI in 2010.  At Hyaluron, Dr. Kinney was responsible for bringing the first high speed vacuum filling/stoppering syringe filler to the US, pioneered Bubble-Free Filling and authored two patents on the topic.  Since leaving Hyaluron, Dr. Kinney has been providing extensive technical and marketing consulting services to SiO2 Medical Products in the development of the market for PECVD coated parenteral containers.  Prior to founding Hyaluron in 1999, Dr. Kinney was Vice President of Operations at Anika Therapeutics Inc. where he was responsible for sterile fill/finish of viscous medical device and drug products in pre-filled syringes.

Dr. Kinney is a long time member of the Parenteral Drug Association (PDA). He has Co-Chaired the Pre-Filled Syringe Conference and given numerous presentations at the PDA Pre-Filled Syringe and other Pre-Filled Syringe Conferences. Dr. Kinney has also participated in glass handling and Pre-Filled Syringe task forces.

Dr. Kinney holds a Doctorate in Chemistry from the University of Massachusetts at Amherst, an MS in Medicinal Chemistry from Northeastern University and a Bachelor of Science from Southeastern Massachusetts University.

Andrea Wagner, Ph.D.

Senior Vice President of Business Development

Dr. Wagner is a dynamic sales and marketing executive with more than 15 years of experience developing new business in firms ranging from virtual startups to global giants within the biotech, pharmaceutical and medical device industries.
Dr. Wagner was Vice President of Business Development at Hyaluron, Inc. where she was responsible for establishing and managing the marketing, sales and project management organizations. During her tenure, revenues increased at a compounded annual growth rate of 60% over a five year period prior to the sale of the Company. The key to Dr. Wagner’s success at Hyaluron was her ability to understand and respond to the demanding needs of customers marshalling products through clinical trials to commercialization. Much of her role was involved in closely monitoring the coordination of the engineering, quality, manufacturing and project management teams to meet the constantly changing customer requirements and critical deadlines. Following her departure from Hyaluron, Dr. Wagner was Co-Founder and President of UpSell Strategy, a consulting firm focused on expanding revenues in life science companies through metric driven sales management. Prior to assuming her role at Hyaluron, Dr. Wagner was Director of Sales and Marketing at Niton (a Thermo Scientific Company) where she worked with the sales team to grow revenues from $4 million to $22 million.

Dr. Wagner has participated in numerous workshops and conferences on the manufacturing of sterile drugs. She has also authored technical papers and written articles on outsourcing of drug and medical device products as well as assisted with technical presentations on fill/finish innovations, process scale up methodology and use of disposable technologies in aseptic manufacturing.

Dr. Wagner holds a Doctorate in Environmental Health and Toxicology from the State University of New York at Albany (SUNY), an MS in Analytical Chemistry from the University of Vermont and a Bachelor of Science from Northern Arizona University.

Paul Souza

Chief Financial Officer

Paul Souza is a financial executive with more than 40 years of operations and finance experience including 25 years as CFO with manufacturing, distribution and service organizations operating primarily in the high technology and life sciences business sectors. Paul has guided businesses through periods of rapid growth, restructurings and turnarounds. He has expertise implementing financial and business management systems as well as experience with raising debt and equity financing, mergers and acquisitions, management buyouts and international operations.

Paul is rejoining the executive team at BSM with whom he served as CFO at Hyaluron, Inc. for 6 years including the successful sale of the business in 2010. Since leaving Hyaluron, Paul has been providing financial and business advisory services to emerging and mid-market firms. Prior to Hyaluron, Paul served as CFO at both Hope Global and Techex. Early in his career, Paul was employed at Millipore Corporation and Worthington Diagnostics in management positions in manufacturing, marketing, materials management and finance before focusing on a financial career.

Paul has an MBA from Babson College, MS Accounting from Bentley College and BBA Marketing from UMass (Amherst).

Debbie Smith

Vice President, Quality Assurance

Debbie Smith joined Berkshire Sterile Manufacturing (BSM) in August of 2017 as Sr. Director of Quality Assurance with responsibilities for quality assurance at BSM.  Debbie was promoted to Vice President of QA at BSM in July of 2018.   At BSM, Debbie oversees a team of Quality Assurance, Document Control, Batch review, release and Supplier Approval aspects of QA.

Debbie Smith leads the Quality Department at Berkshire Sterile Manufacturing to ensure product quality and reliability to meet or exceed customer expectations.  Debbie has over fourteen years of extensive quality experience in the pharmaceutical and Biotechnology industries with a focus on aseptic commercial production.

Prior to joining BSM, Debbie held various positions for 14 years supporting the aseptic manufacturing of commercial product at Pfizer, Inc. Throughout her career at Pfizer, Debbie managed the Quality Assurance department responsible for the disposition of incoming materials and vaccine final product. Debbie has supported the Microbiology and Analytical laboratories to ensure compliance with GLP, as well as Operations with the startup projects for the vial line and the tandem fill of the syringe line.

Debbie has a BS degree in Business and Computing from Herbert H. Lehman College.

Devin Wigington, M.S.

Vice President, Quality Control

Devin Wigington is responsible for overseeing all aspects of the analytical and microbiology Quality Control laboratories.  Devin has more than 19 years of quality control experience within the pharmaceutical and biotechnology industries.  During his career, he has managed groups responsible for testing at all stages. This includes development of methods to support preclinical studies, preparing methods for early stage cGMP manufacturing, method validation, and release testing of commercial products.

Prior to joining Berkshire Sterile Manufacturing Devin previously oversaw Quality Control and Analytical Methods Development groups at VaxInnate. Devin was responsible for the development of methods for preclinical work to Phase I cGMP manufacturing.  Before VaxInnate, Devin supervised and managed Quality Control departments that supported commercial products at both ImClone (later Eli Lilly) and Enzon Pharmaceuticals. Devin started his career working for the GMP manufacturing service provider Chesapeake Biological Laboratories (now Emergent BioSolutions).  He became the Quality Control Supervisor before leaving for graduate school.

Devin has an MS in Analytical Chemistry from the University of Maryland, Baltimore County (UMBC) and a BS in Chemistry from Mount Saint Mary’s College.

 

Jeremy Griffin, MBA, PMP

Vice President, Engineering

Jeremy Griffin joined Berkshire Sterile Manufacturing (BSM) in January of 2018 as Vice President of Engineering responsible for validation and process engineering. Jeremy joined BSM with 14 years of experience in the pharmaceutical and biotech industry, focused in aseptic processing. At BSM, Jeremy oversees a team of validation and process engineering professionals and has performed numerous development activities with BSM as well as in prior employment capacities.

Prior to joining BSM, Jeremy held consulting positions with ProPharma Group on two separate occasions for a total of seven years; first as a Senior Validation Engineer and immediately prior to joining BSM as a Project Manager. Jeremy consulted in engineering, process development, quality, regulatory, and validation for Merck, Pfizer, Elanco, Emergent Biosolutions, Aptuit, and other companies. Jeremy has also held senior level management positions in sterile contract fill / finish manufacturing and engineering. At Alcami, formerly AAIPharma Services, he held a position as Sr. Manager of Manufacturing (Site Head) for their sterile fill / finish site. Over the course of four years at Grand River Aseptic Manufacturing, he was the Head of Manufacturing, Facilities and Engineering and also lead validation engineering.

Jeremy holds a BS in Business Administration from Colorado Technical University and an MBA from Limestone College as well as an Executive Leadership Certificate from Cornell University.  He has undergone advanced training and certification in cGMPs, Aseptic Technique, Application of Computer Systems Validation, Sterilization, High Purity Utility Systems, Project Management, and Automation and Controls.