Cytovance Biologics, a contract manufacturing organization of mammalian and microbial biologics, has appointed Mark Ambrose, PhD., as senior director of quality systems and compliance and Anne Garstka as director of commercial compliance.

​Ambrose joins Cytovance Biologics with 20 years of quality experience.  Prior to Cytovance, he served as the vice president of quality at Nuron Biotech in Exton, Pennsylvania. 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, Ambrose was employed by Wyeth Biotech, now Pfizer, in Collegeville, Pennsylvania 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 lifecycle product quality strategies and leading cross-functional teams in achieving product targets and issue resolution. Specific to his role in sustainable compliance, he served as the subject matter expert for three Wyeth quality systems (laboratory operations, investigations, and stability programs).  

Garstka joins Cytovance Biologics with over 15 years of quality and compliance management experience. Prior to Cytovance, she  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, she was employed by Celgene Celluar Therapeutics in Warren, New Jersey 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 led interdepartmental activities for quality improvement projects, gap analysis and risk analysis. She also held various positions with Celgene Corporation, Amgen, Watson Pharmaceuticals, and SP Pharmaceuticals during her tenure in quality.

Source: Cytovance Biologics