Welcome!

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
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
DevOps promotes continuous improvement through a culture of collaboration. But in real terms, how do you: Integrate activities across diverse teams and services? Make objective decisions with system-wide visibility? Use feedback loops to enable learning and improvement? With technology insights and real-world examples, in his general session at @DevOpsSummit, at 21st Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, explored how leading organizations use data-driven DevOps to close th...
Continuous Delivery makes it possible to exploit findings of cognitive psychology and neuroscience to increase the productivity and happiness of our teams. In his session at 22nd Cloud Expo | DXWorld Expo, Daniel Jones, CTO of EngineerBetter, will answer: How can we improve willpower and decrease technical debt? Is the present bias real? How can we turn it to our advantage? Can you increase a team’s effective IQ? How do DevOps & Product Teams increase empathy, and what impact does empath...
As many know, the first generation of Cloud Management Platform (CMP) solutions were designed for managing virtual infrastructure (IaaS) and traditional applications. But that's no longer enough to satisfy evolving and complex business requirements. In his session at 21st Cloud Expo, Scott Davis, Embotics CTO, explored how next-generation CMPs ensure organizations can manage cloud-native and microservice-based application architectures, while also facilitating agile DevOps methodology. He expla...
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software. They hope to capture value from emerging technologies such as IoT, SDN, and AI. Ultimately, irrespective of the vertical, it is about deriving value from independent software applications participating in an ecosystem as one comprehensive solution. In his session at @ThingsExpo, Kausik Sridhar, founder and CTO of Pulzze Systems, discussed how given the magnitude of today's application ...
Modern software design has fundamentally changed how we manage applications, causing many to turn to containers as the new virtual machine for resource management. As container adoption grows beyond stateless applications to stateful workloads, the need for persistent storage is foundational - something customers routinely cite as a top pain point. In his session at @DevOpsSummit at 21st Cloud Expo, Bill Borsari, Head of Systems Engineering at Datera, explored how organizations can reap the bene...
With tough new regulations coming to Europe on data privacy in May 2018, Calligo will explain why in reality the effect is global and transforms how you consider critical data. EU GDPR fundamentally rewrites the rules for cloud, Big Data and IoT. In his session at 21st Cloud Expo, Adam Ryan, Vice President and General Manager EMEA at Calligo, examined the regulations and provided insight on how it affects technology, challenges the established rules and will usher in new levels of diligence arou...
You know you need the cloud, but you're hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You're looking at private cloud solutions based on hyperconverged infrastructure, but you're concerned with the limits inherent in those technologies. What do you do?
Recently, WebRTC has a lot of eyes from market. The use cases of WebRTC are expanding - video chat, online education, online health care etc. Not only for human-to-human communication, but also IoT use cases such as machine to human use cases can be seen recently. One of the typical use-case is remote camera monitoring. With WebRTC, people can have interoperability and flexibility for deploying monitoring service. However, the benefit of WebRTC for IoT is not only its convenience and interopera...
Sanjeev Sharma Joins June 5-7, 2018 @DevOpsSummit at @Cloud Expo New York Faculty. Sanjeev Sharma is an internationally known DevOps and Cloud Transformation thought leader, technology executive, and author. Sanjeev's industry experience includes tenures as CTO, Technical Sales leader, and Cloud Architect leader. As an IBM Distinguished Engineer, Sanjeev is recognized at the highest levels of IBM's core of technical leaders.
In his general session at 21st Cloud Expo, Greg Dumas, Calligo’s Vice President and G.M. of US operations, discussed the new Global Data Protection Regulation and how Calligo can help business stay compliant in digitally globalized world. Greg Dumas is Calligo's Vice President and G.M. of US operations. Calligo is an established service provider that provides an innovative platform for trusted cloud solutions. Calligo’s customers are typically most concerned about GDPR compliance, application p...
Mobile device usage has increased exponentially during the past several years, as consumers rely on handhelds for everything from news and weather to banking and purchases. What can we expect in the next few years? The way in which we interact with our devices will fundamentally change, as businesses leverage Artificial Intelligence. We already see this taking shape as businesses leverage AI for cost savings and customer responsiveness. This trend will continue, as AI is used for more sophistica...
The 22nd International Cloud Expo | 1st DXWorld Expo has announced that its Call for Papers is open. Cloud Expo | DXWorld Expo, to be held June 5-7, 2018, at the Javits Center in New York, NY, brings together Cloud Computing, Digital Transformation, Big Data, Internet of Things, DevOps, Machine Learning and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding busin...
SYS-CON Events announced today that Synametrics Technologies will exhibit at SYS-CON's 22nd International Cloud Expo®, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Synametrics Technologies is a privately held company based in Plainsboro, New Jersey that has been providing solutions for the developer community since 1997. Based on the success of its initial product offerings such as WinSQL, Xeams, SynaMan and Syncrify, Synametrics continues to create and hone inn...
Smart cities have the potential to change our lives at so many levels for citizens: less pollution, reduced parking obstacles, better health, education and more energy savings. Real-time data streaming and the Internet of Things (IoT) possess the power to turn this vision into a reality. However, most organizations today are building their data infrastructure to focus solely on addressing immediate business needs vs. a platform capable of quickly adapting emerging technologies to address future ...