With more than 30 years of experience in analytical chemistry and quality control testing within a cGMP environment, specifically in the areas of extractables and leachables and container closure integrity testing for both pharmaceutical packaging systems and drug delivery devices, Jen brings a level of knowledge and understanding to the CS Analytical Team that can help and benefit our clients as they work to develop and qualify their package systems

CLIFTON, N.J., April 14, 2026 /PRNewswire/ -- CS Analytical Laboratory, the world's only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to package and container testing for the pharmaceutical, biotechnology, and medical device industries is excited to announce the appointment of Jennifer Roark to the position of Director of Scientific Affairs. In this position she will play a key management role in the continued growth and expansion of the CS Analytical service offering, will assist in the leadership development of key staff members and will represent CS Analytical amongst numerous industry groups to include ASTM, USP, and PDA.

"With more than 30 years of experience in analytical chemistry and quality control testing within a cGMP environment specifically in the areas of extractables and leachables and container closure integrity testing for both pharmaceutical packaging systems and drug delivery devices, Jen brings a level of knowledge and understanding to the CS Analytical Team that can help and benefit our clients as they work to develop and qualify their package systems," noted CS Analytical Chief Executive Officer Brian Mulhall. "We are extremely excited and fortunate to have her as part of the CS Analytical Team."

With a plethora of hands-on experience managing groups that perform quality control testing in a cGMP environment, Jen has been involved with numerous methods development and validation programs and has co-published a series of articles on analytical method validation. Other key career highlights include:

• Current voting member of ASTM Committee E55 on the Manufacture of Pharmaceutical and Biopharmaceutical Products, Subcommittee E55.06 Microbial Contamination Control.
   
• Current voting member of ASTM Committee F02 on Primary Barrier Packaging, Subcommittee F02.40 on Package Integrity.
   
• From 2018 until 2023 volunteered on the USP Expert Panel for the revision of general chapters <660> Containers – Glass and <1660> Evaluation of Inner Surface Durability of Glass Containers.
   
• In 2017 and 2018 Jen served as a co-instructor for three container closure integrity workshops for the Parenteral Drug Association (PDA) in Europe.
   
• In 2021, Jen served on the AAMI TIB-WG04 – Elastomeric parts, components, and packaging committee, where she contributed to the drafting of CR514 Guidance for closed system transfer device (CSTD) testing with hazardous drugs.
   
• She serves as a US Expert Member for ISO TC 76/WG 2 and WG 4, as the project manager for the revision of ISO 13926-2:2017 Pen Systems- Part 2: Plunger stoppers for pen-injectors for medical use.
   
• Numerous PDA and Industry Presentations to include MD&M Minneapolis 2018, CPHI Worldwide 2022, PDA Universe of Prefilled Syringes and Injection Devices 2024, and at the PDA Parenteral Packaging Conferences in both 2025 and 2026.
   
• Jen has published numerous blogs, whitepapers, and technical reports on container closure integrity topics and currently serves as a co-leader of the task force to revise PDA Technical Report 27 Pharmaceutical Package Integrity, in addition to being an independent expert on the USP General Chapters – Packaging and Distribution Expert Committee, chairing the subcommittee for the revision of USP <1207>.

About CS Analytical Laboratory

The world's only cGMP, FDA-registered contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, the CS Analytical Team includes world-leading experts and thought-leaders on FDA and EU regulatory expectations and USP and EP primary package testing requirements inclusive of container closure integrity (CCI) testing (CCIT). Test services include CCI method development, validation, and analysis, USP/EP/JP physical and physicochemical testing, and Comprehensive and Complementary services for all common or unique primary packaging components and systems inclusive of glass, plastic, elastomeric, and more. CS Analytical is the single source to ensure a regulated industry product-package system meets strict, complex, and ever-changing regulatory requirements. With recent growth and expansion programs, CS Analytical also offers FDA regulated test programs for all types of raw materials and excipients, USP and EP Gas Qualification testing and a variety of Microbiological testing services to include USP 87 and USP 788.

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SOURCE CS Analytical