BioMARC’s Leadership Team is dedicated to the commercialization and manufacturing of biologics. Each member of the Leadership Team plays a vital role in the completion of the Product Life Cycle, whether it be by directly working in the labs with the products, or working with the client. The Leadership Team is responsible for the functionality of the company by working with clients and by managing each of BioMARC’s departments to ensure efficiency and completion of the substance through the Product Life Cycle.
Director & Professor
John H Wyckoff III, Ph.D. is an immunologist with over 33 years combined academic and industrial experience focused on host defense/immune mechanisms, pathogen/antigen identification, conventional and cutting-edge vaccine development and product licensure predominantly in the animal health sector. John is highly experienced in high containment laboratory design, construction, commissioning and registration, as well as advancement and transfer of pipeline projects from research to development and into manufacturing. Previous employment has been with Oklahoma State University Center for Veterinary Health Sciences, Merial Limited, Boehringer Ingelheim Vetmedica, Inc. and Elanco. His industry experience spans leadership of cross-functional teams based in Research and Development, Process Development and Analytical Development including planning strategies and advancement of pipeline projects in collaboration with marketing and sales functions. He joined BioMARC in 2017 and is Colorado State University’s designated responsible individual (Principal Investigator) and point of contact for BioMARC-related activities. He has published peer review articles describing research results in infectious diseases and vaccines, in particular on cellular immune mechanisms in bovine brucellosis, performed research on numerous BSL-2 and BSL-3 bacterial and viral agents. He also has experience with leading audit teams through USDA inspections of research and development facilities in addition to CDC inspections of BSL-3 laboratories and Select Agent Programs.
Manufacturing & Product Development Manager
Darragn Heaslip leads the production team on early stage GMP projects. He has 15 years of experience in high containment BSL-2 and BSL-3 and select agent handling and is BioMARC’s Bio-safety liaison with Colorado State University. As such, he provides the training and oversight of BioMARC’s BSL-2 and BSL-3 areas. He has extensive experience leading technology transfer and/or development of assays ranging from cell culture and molecular biology techniques to chromatography and protein characterization and purification methods including whole virions. He also has experience working with the VEE VRP vaccine platform. He has developed, verified, and conducted assays for both GLP and cGMP use. In addition, Darragh provides technical oversight for new assays being transitioned into the Quality Control group for use during in-process or release testing of cGMP materials. His responsibility includes the training and transitioning of processes and methods to the GMP production teams, when needed.
Head of Quality
With over 15 years of Quality Management experience mentoring managers, supervisors, quality assurance specialists, engineers, and analytical chemists, Celeste O’Connor, has over 23 years of Quality Management System, (QA/QC/Validation) experience in the pharmaceutical industry. She demonstrates excellence in quality by example, to meet regulatory internal standards and holds an ASQ Certified Quality Auditor (CQA) Certification since 1999. She directs the Quality Assurance Department for a contract manufacturing for pre-clinical to commercial drugs and biologics. She is responsible for presenting the quality system, to regulatory agencies and customer auditors. Celeste creates and delivers Quality Management Review meeting presentations and KPI tracking. She also maintains site compliance to ICH Q7, CFR 210 and 211, and applicable regulatory standards, as well as, generates annual product quality reviews. She is responsible for key Quality System: batch release, deviation, CAPA, internal audits, change control, and laboratory OOS investigations. Celeste has extensive experience in hosting audits for worldwide regulatory authorities including FDA, EU, Health Canada, and Anvisa Central and South Americas. She led the BioMARC inspection and readiness program in 2015, and managed a regulatory inspection in 2016 with no form 483 observations. She has a Bachelor of Science in Biology, from Northeastern University.
Quality Control Manager
JaNae Myers has over 10 years of experience with analytical method development, transfer, verification, qualification, validation, and commercialization in the pharmaceutical industry. She has managed and provided quality oversight for the transfer and/or validation of over 100 analytical methods for at least 15 different clinical and commercial pharmaceutical products, spanning 12 or more technologies. She has also provided analytical product quality support for clinical and commercial products produced under cGMPS, including analytical method control trending and analysis, invalid rate analysis, reference standard qualification and management, and authoring the analytical component of numerous regulatory filings and communications. JaNae currently oversees and coordinates the cGMP quality control laboratory and operations for the group. Her activities include working with Process Development, Manufacturing, and Sponsor technical teams to bring technologies into the cGMP analytical laboratories and ensure that they meet phase-appropriate regulatory guidance and industry expectations, as well as, the creation of standard operating procedures, protocols and reports, to support cGMP production. JaNae has her BS in Biological Sciences and her BA in Anthropology from Colorado State University. She was a doctoral candidate in Biological Anthropology (Human Molecular Genetics) at the University of New Mexico.
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Facilities & Operations Manager
Nate Hildebrandt is a specialist with over 15 consecutive years of experience pioneering well planned, documented, and managed engineering approaches to the start-up, operation, and maintenance of facilities, systems, and equipment that results in a safe and functional environment that meets established design requirements. Nate is certified by the Association of Energy Engineers as a Certified Building Commissioning Professional (CBCP).
Head of Project Management
Joanna Ellinghuysen has been in the pharmaceutical and biotechnology industry since 1995 and has been in a project management role since 2011. She has extensive experience with pharmaceutical manufacturing and development projects at all phases of development; discovery, pre-clinical, clinical, to commercial. Her experience includes leadership roles in and successful completion of 2 regulatory pre-approval inspections, multiple cGMP regulatory inspections, as well as, numerous clinical and pre-clinical projects. In addition, she has managed and/or been a key resource for 4 plant start-ups from construction to commissioning through GMP production. She has worked with multiple product types (small molecules, peptides, and biologics) across a variety of manufacturing phases including bulk API, bulk drug substance, and final drug product. Prior to her project management roles, Joanna led manufacturing teams to create GMP programs and deliver products from phase 1 though commercial manufacturing for bulk production to sterile fill finish operations. She has a BS in Biology, and has been certified as a Six Sigma Lean Green Belt by Aveta Business Institute.
Business Development Manager & Contract Supervisor
Sandy Brown is BioMARC’s Business Development & Contract Manufacturing Supervisor. As such, Sandy is responsible for customer contact, maintaining customer relationships, creating business proposals, budgeting projects, and being one of the main communication bridges between BioMARC’s multi-disciplinary departments and the client. Apart from customer relations and contact management, Sandy also works on the marketing for BioMARC, specifically by helping create the new website for the company. Previous to BioMARC, her employment includes being a Sr. Project Coordinator and Sr Material Planner at Woodward, the Development Project Manager at Tolmar Inc., and as the Product Manager, as well as, production and inventory planning and purchasing for Pr. Pharmaceuticals. She has extensive experience coordinating projects, leading multi-disciplined teams through the Product Life Cycle, working under cGMPs, managing inventory for production and customer sales, developing and maintaining communication channels between departments, and implementing a company-wide materials management planning system. Sandy has a BS Degree in Business Administration (concentrations in both Management and Marketing) from Colorado State University, an Associate of Applied Science Degree in Accounting from Front Range Community College, a Six Sigma Green Belt Certification, and a Certification in Production and Inventory Management (CPIM).