Suttons Creek Expands Combination Product Expertise with Five New Hires

2024 continues Suttons Creek’s growth streak as we hire five new team members to keep up with combination market demand for outside drug delivery device development support. These new hires will allow us to resource for the growing number of projects requested by early-stage organizations and established Pharma and Biotech who need outsourced expertise to effectively bring their combination product to market.

Albana Thorpe joins Carolyn Dorgan and Jonathan Amaya-Hodges as the company’s third Director, Technical Services, reporting directly to Suttons Creek’s COO & President, Rob Schulz.

With over 16 years of experience in the Medical Device and Combination Product industries at global companies, Albana comes to SCI from West Pharmaceuticals. At West, she had been operating for the last 4 years as a Program Director after 4 years of managing On Body Delivery System projects as a Project Manager. Before her time at West, she worked in Manufacturing Engineering for Bard Peripheral Vascular. “We are excited to be able to benefit from Albana’s background leading client combination product programs on the supplier side,” says Rob Schulz, “as well as her strong program leadership on large cross-functional programs.”  Albana has a BS in Biomedical Engineering from Arizona State University and hands on experience in Development, Engineering, Manufacturing Process Development and Program Management for various types of medical devices and combination products (on-body injectors, pre-filled syringes, and implantable products). “I am excited to join Suttons Creek leadership team,” shares Albana. “I have a passion for meeting patients’ needs, and this new role will allow me to blend my development and program management backgrounds to drive excellence in our client’s offerings.”

Dr. Sally Wixson joins Suttons Creek’s regulatory expert team as a Senior Principal Regulatory Consultant bringing over 20 years of vast regulatory experience in drugs, biologics, medical devices, and combination products. She developed global regulatory strategies and submissions for medical devices, drug-device combination products, drugs and biologics in a variety of fields including Oncology, Immunology, Neurosciences, Infectious Diseases, Metabolic Disorders, Cardiology, Ophthalmology, Gene Therapy and Orphan drugs at many major global companies, including Merck (and predecessor companies), Integra LifeSciences, Allergan, Dr. Reddy’s, J&J (Janssen and Ethicon), and Takeda.  “We are excited to have Sally’s expertise on our team,” says Amaya-Hodges. “She has extensive experience leading successful international Health Authority interactions including CDRH, CDER, CBER, and OCP within the US FDA, as well as Notified Bodies in the European Union for combination products. Her experience will be highly beneficial to our clients.” In addition to her vast practical experience, Sally holds a BS in Animal Science from Penn State, a VMD from Penn, and an MS in Laboratory Animal Science from Penn State. She also holds a dual RAPS RAC certificate in drugs & medical devices, has completed a Mini MBA from Rutgers and a PMP certification, and is a diplomate by the American College of Laboratory Animal Medicine.

Michaela Ozyp joins the team as a Senior Consultant with 8+ years of experience in medical devices and a specialty focus in systems engineering with experience in software and imaging-based  medical devices. She brings practical, hands-on knowledge of product development from her past work experience at Biofourmis and Canon USA, as a CDRH FDA reviewer of medical devices and combination products (including syringes, auto-injectors, nasal sprays, infusion pumps, and more), and as a clinical engineer supporting medical device purchasing for the global US Naval Hospital network. She holds a BS in Biomedical Engineering from the University of Delaware and has played a key role during her career in new product development, testing, risk management, and DHF management of various kinds of medical device types, including software as a medical device, wearable health monitoring devices, and optical imaging devices. “Our clients are going to love how Michaela approaches every aspect of her work with optimism,” says direct-report Jonathan Amaya-Hodges. “Her reputation is to deliver quality results utilizing a wide breadth of development and regulatory knowledge and a keen attention to detail.”

Brian Pullins and Katherine Nishimoto build out Project Management Operations, headed by Mickey Burg, as Senior Project Managers. They will both work on a variety of internal and client-facing programs focused on executing Suttons Creek’s PMO process. Brian brings over 13 years of medical device experience and 8 years of project management experience in a variety of medical device products including energy-based devices. With a BS in Biomedical Engineering from Arizona State University, his prior hands-on experience includes Merz Aesthetics, Auer Medical, Viant Medical and MedPlast. Specializing in device development and new product introduction, Brian’s experience collaborating with cross-functional teams and stakeholders has equipped him with the ability to navigate complex projects and foster productive working relationships. Katherine, an Illinois Institute of Technology graduate (B.S. Biomedical Engineering, Specialization in Neural Engineering), brings 5 years of combination product and medical device engineering experience with her to SCI. Prior to joining Suttons Creek, Katherine led a cross-functional team for MRI Safety as a System Engineer at Abbott Laboratories and led device development activities across cross-functional departments for the commercialization of combination products for Gilead Sciences. In addition to her project management responsibilities,, Katherine will also be providing engineering and quality consultation on client projects. “The growth of our PMO team means continued excellence in resourcing, budget-management, and project deliverables execution as our client-base expands,” says Mickey. “Brian’s proactive approach to problem-solving and ability to adapt to changing priorities, coupled with Katherine’s cross-functional project management and device development expertise, will be a great asset to our internal team and our clients.”

Suttons Creek is proud to introduce these new team members to our industry and clients. They continue to strengthen an already robust group of combination product experts and allow the company to support even more clients, putting even more life-changing combination products into patients’ hands.