SYS-CON MEDIA Authors: Adine Deford, Cynthia Dunlop, Harry Trott, Xenia von Wedel, Peter Silva

News Feed Item

Cytovance Biologics Strengthens Quality Team With Addition of Quality Systems and Commercial Compliance Directors

OKLAHOMA CITY, OK -- (Marketwired) -- 08/12/14 -- 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.

Media Contact:
Valerie McDonnell
VP of Sales and Business Development
Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
"We help companies that are using a lot of Software as a Service. We help companies manage and gain visibility into what people are using inside the company and decide to secure them or use standards to lock down or to embrace the adoption of SaaS inside the company," explained Scott Kriz, Co-founder and CEO of Bitium, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
15th Cloud Expo, which took place Nov. 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA, expanded the conference content of @ThingsExpo, Big Data Expo, and DevOps Summit to include two developer events. IBM held a Bluemix Developer Playground on November 5 and ElasticBox held a Hackathon on November 6. Both events took place on the expo floor. The Bluemix Developer Playground, for developers of all levels, highlighted the ease of use of Bluemix, its services and functionalit...
Some developers believe that monitoring is a function of the operations team. Some operations teams firmly believe that monitoring the systems they maintain is sufficient to run the business successfully. Most of them are wrong. The complexity of today's applications have gone far and beyond the capabilities of "traditional" system-level monitoring tools and approaches and requires much broader knowledge of business and applications as a whole. The goal of DevOps is to connect all aspects of app...
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
Want to enable self-service provisioning of application environments in minutes that mirror production? Can you automatically provide rich data with code-level detail back to the developers when issues occur in production? In his session at DevOps Summit, David Tesar, Microsoft Technical Evangelist on Microsoft Azure and DevOps, will discuss how to accomplish this and more utilizing technologies such as Microsoft Azure, Visual Studio online, and Application Insights in this demo-heavy session.
When an enterprise builds a hybrid IaaS cloud connecting its data center to one or more public clouds, security is often a major topic along with the other challenges involved. Security is closely intertwined with the networking choices made for the hybrid cloud. Traditional networking approaches for building a hybrid cloud try to kludge together the enterprise infrastructure with the public cloud. Consequently this approach requires risky, deep "surgery" including changes to firewalls, subnets...
DevOps is all about agility. However, you don't want to be on a high-speed bus to nowhere. The right DevOps approach controls velocity with a tight feedback loop that not only consists of operational data but also incorporates business context. With a business context in the decision making, the right business priorities are incorporated, which results in a higher value creation. In his session at DevOps Summit, Todd Rader, Solutions Architect at AppDynamics, discussed key monitoring techniques...
Cultural, regulatory, environmental, political and economic (CREPE) conditions over the past decade are creating cross-industry solution spaces that require processes and technologies from both the Internet of Things (IoT), and Data Management and Analytics (DMA). These solution spaces are evolving into Sensor Analytics Ecosystems (SAE) that represent significant new opportunities for organizations of all types. Public Utilities throughout the world, providing electricity, natural gas and water,...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happe...
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
The Internet of Things is tied together with a thin strand that is known as time. Coincidentally, at the core of nearly all data analytics is a timestamp. When working with time series data there are a few core principles that everyone should consider, especially across datasets where time is the common boundary. In his session at Internet of @ThingsExpo, Jim Scott, Director of Enterprise Strategy & Architecture at MapR Technologies, discussed single-value, geo-spatial, and log time series dat...
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and asse...
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, discussed how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money!