Cytovance Biologics Strengthens Quality Team With Addition of Quality Systems and Commercial Compliance Directors
August 12, 2014 - Oklahoma City, OK
Cytovance Biologics, a leading full-service contract manufacturing organization ("CMO") of mammalian and microbial biologics, welcomes Mark Ambrose, Ph.D., as Senior Director of Quality Systems and Compliance and Anne Garstka as Director of Commercial Compliance.
"We are very fortunate to welcome such seasoned professionals to the Cytovance Quality team," said Maria Lopez, Vice President of Quality for Cytovance Biologics. "Mark's experience with CMO/client relationships and Anne's experience in working side-by-side with internal and external customers will be tremendous assets to the Company. Their combined wealth of knowledge will allow Cytovance to expedite process and system improvements so that we can become even better partners with our clients."
Dr. Ambrose joins Cytovance Biologics with 20 years of quality experience. Prior to Cytovance, Dr. Ambrose served as the Vice President of Quality at Nuron Biotech in Exton, Pa. In this role, he was responsible for quality leadership in all facets of the company including GMP, GCP, GDP and GLP and the development and implementation of quality systems to support clinical and commercial products. In a limited capacity, he also served as the acting Head of Regulatory Affairs.
Before Nuron Biotech, Dr. Ambrose was employed by Wyeth Biotech, now Pfizer, in Collegeville, Pa. as both a Quality Operations Product Leader and Director of Sustainable Compliance. In these capacities, he was responsible for global product quality for Pfizer's Meningitec vaccine including formulation and cross-site implementation of life cycle product quality strategies and leading cross-functional teams in achieving product targets and issue resolution. Specific to his role in sustainable compliance, Dr. Ambrose served as the subject matter expert for three Wyeth Quality Systems namely Laboratory Operations, Investigations and Stability Programs.
Dr. Ambrose earned his Bachelor of Science degree in Biology from George Mason University in Fairfax, Va. and his Post-Doctoral degree in Immunnology/Virology from Baylor College of Medicine in Houston, Texas.
Ms. Garstka joins Cytovance Biologics with over 15 years of quality and compliance management experience. Prior to Cytovance, Ms. Garstka served as the Director of Quality Assurance and Compliance for Neos Therapeutics in Grand Prairie, Texas. In this role, she developed and implemented numerous quality policies to ensure compliance to regulatory requirements and modified and maintained quality systems to meet changing industry guidelines all while managing a team of eight quality professionals.
Before Neos Therapeutics, Ms. Garstka was employed by Celgene Celluar Therapeutics in Warren, N.J as a Quality Assurance Manager where she was responsible for developing and maintaining quality systems to meet industry requirements for a pharmaceutical development/clinical manufacturing center. She also provided strategic input into complex cell based development projects and championed interdepartmental activities for quality improvement projects, gap analysis and risk analysis.
Ms. Garskta also held various positions with Celgene Corporation, Amgen, Watson Pharmaceuticals, and SP Pharmaceuticals during her tenure in Quality. She holds a Bachelor of Science degree in Chemistry from Juanita College in Huntington, Pa.
About Cytovance Biologics, Inc.
Cytovance Biologics is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from both mammalian cell culture and microbial fermentation. In addition to its cGMP manufacturing services, the company offers process development, cGMP cell banking and support services from its Oklahoma City state-of-the-art facilities.
Learn more about Cytovance Biologics at www.cytovance.com.
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