Experience with contract development and manufacturing organization (CDMO); focus on program & alliance management
Manufacturing Operations
Quality Assurance
Regulatory Affairs
Project & Program Management
Product & Process Development
Diligence & Business Strategy
Analytical Development
Sara brings to Dark Horse her ten years of contract development and manufacturing organization (CDMO) experience, focusing primarily on program & alliance management. She has a proven record of building and maintaining relationships within a cross functional matrix to continually push the progress and success for production of quality life-saving therapies for patients. Sara also has extensive knowledge in generation of scopes of work, technological transfer, clinical manufacturing, and lot disposition.
With DHC clients, Sara has found that she can attribute successful managing of the overall progress of client programs to her skills in leading teams and positioning resources to inhabit the most desired project outcomes as they relate to on-time delivery. Sara prioritizes a deep understanding of each clients' needs as well as building trust and successful relationships with those clients because this is a recipe for long-term success in project management.
In 2009, Sara joined ARL (Analytical Research Laboratories) as a pharmaceutical sample logistics administrator and quickly transferred to the quality control group where she began to lead testing activities in the microbiology department which supported compounding and hospital pharmacies, drug manufacturers, and raw material suppliers. ARL is where she first gained exposure to operating within controlled environments such as ISO 5 and ISO 7 spaces and managing laboratory activities from testing per pharmacopeia specifications to reporting out results ensuring that clients receive documentation to release product for patient use within the agreed-upon timeline.
In 2011, Sara joined Cytovance Biologics, where she continued to work within the quality group for three years, expanding her skill set in review of GMP documentation, drafting of reports, and leading multiple activities within the quality control group and external vendors to support clinical batch disposition. By 2014, Sara made a full transition to the program management group where she cross functionally led program activities from full development in R&D (Research and Development) to Phase III clinical production. At Cytovance, Sara successfully led the technological transfer of multiple biopharmaceutical programs including cell line development, mammalian cell culture, and microbial fermentation.
In 2018, Sara joined Cognate Bioservices, where she continued to lead programs in the cell and gene therapy space. Sara was extensively involved in building out the systems within the organization while also establishing the program management office where she developed a client project management team of ten diverse individuals. She was heavily involved in process improvement activities throughout the company using her previous experience coupled with new ideas to foster an atmosphere of continuous change. Sara successfully managed multiple technological transfers for autologous and allogeneic products. She was instrumental in establishing CDMO standard practices at Cognate and continually focused on people and relationship management, which contributed to the overall success and timeliness of clients reaching clinical production and the end result of saving lives.
Dark Horse Consulting Group
Senior Consultant
Cognate Bioservices
Director of Program Management
Cytovance Biologics
Associate Director of Program Management
Quality Control External Testing Specialist
Quality Control Microbiologist
Analytical Research Laboratories
Quality Control Microbiologist
Sample Logistics Administrator
University of Central Oklahoma
MBA in General Business
B.S. in Biology
.png)
