#USA #CS Analytical #Clifton #Jennifer Roark #Scientific Affairs

Jennifer Roark Appointed Director of Scientific Affairs at CS Analytical Laboratory

CS Analytical Laboratory, recognized globally as the only cGMP, FDA-registered contract laboratory entirely focused on package and container testing for the pharmaceutical, biotechnology, and medical device sectors, has announced the appointment of Jennifer Roark to the pivotal role of Director of Scientific Affairs. This strategic move comes as part of the company’s ongoing commitment to advance its service offerings and industry leadership.

With a robust background encompassing over 30 years in analytical chemistry and quality control testing, Jen Roark brings a wealth of knowledge in the specific domains of extractables and leachables, as well as container closure integrity testing for pharmaceutical packaging systems and drug delivery devices. Her extensive experience and expertise are expected to greatly benefit CS Analytical's clientele in their endeavors to develop and qualify their packaging systems effectively.

Brian Mulhall, CEO of CS Analytical, expressed enthusiasm about Roark’s appointment, stating, "With her breadth of experience managing quality control testing in a cGMP setting, Jen is an invaluable addition to our team. Her proficiency will enable us to better support our clients and enhance our scientific programs. We are incredibly fortunate to have her onboard."

Throughout her distinguished career, Roark has played a significant role in various methods development and validation projects and has co-authored numerous articles related to analytical method validation. Notable achievements in her career include:

• - Serving as a voting member of the ASTM Committee E55, focusing on the manufacture of pharmaceutical and biopharmaceutical products, as well as the Microbial Contamination Control Subcommittee E55.06.
• - Actively participating as a voting member in ASTM Committee F02 which oversees primary barrier packaging, contributing specifically to the Package Integrity Subcommittee F02.40.
• - Volunteering on the USP Expert Panel for revising critical general chapters related to container standards between 2018 and 2023.
• - Lead co-instructor for container closure integrity workshops organized by the Parenteral Drug Association (PDA) in Europe during the years 2017 and 2018.
• - Involvement in AAMI TIB-WG04, where she helped draft guidance for closed-system transfer device (CSTD) testing specifically for hazardous drugs.
• - Serving as a U.S. expert for ISO projects, particularly overseeing revisions to the specifications for pen injectors used in medical settings.
• - Presenting at several significant industry conferences such as MDM Minneapolis and PDA Universe of Prefilled Syringes, where she contributed her insights on packaging integrity and safety.

Beyond her hands-on management experience, Roark has also authored various blogs, whitepapers, and technical documents, significantly contributing to the field of container closure integrity. She currently leads efforts to revise the PDA Technical Report 27 on Pharmaceutical Package Integrity and serves as a crucial expert on the USP General Chapters – Packaging and Distribution Expert Committee.

CS Analytical is dedicated to upholding the highest standards in testing services, particularly regarding container closure integrity (CCI) testing, ensuring compliance with stringent regulatory requirements governing the pharmaceutical and biotechnology sectors. With Roark’s leadership, the laboratory aims to enhance its offerings in developing methodologies and conducting validation programs that meet the evolving demands of regulatory authorities.

As CS Analytical continues to expand its capabilities, Roark’s role will be pivotal in fostering innovation and excellence in service provision. The laboratory remains committed to supporting its customers in navigating the complexities of package testing, guaranteeing that their products meet both safety and efficacy requirements. Given her extensive background and vision for scientific advancement, Jennifer Roark's leadership will undoubtedly steer CS Analytical towards new heights of success in the industry.

For further information regarding CS Analytical and its wide-ranging laboratory services, please refer to their website or contact their office directly.

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