PCI Synthesis Adds Manufacturing, QC, Business, and R&D Expertise

February 1, 2012

PCI Synthesis, Inc., a 12-year-old custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products, has significantly increased its bench strength in quality control and research and development with the hiring of several experts in recent months.

New in-house experts include:

  • Elie Saikali, Ph.D., Director of Manufacturing: A holder of seven patents and a rich publication history, Elie Saikali oversees and directs all manufacturing operations according to cGMP, FDA and ICH guidelines. Dr. Saikali comes to PCI Synthesis from Lonza Inc. where he held increasingly responsible positions in process research and development ultimately holding the title of product manager. He earned his doctorate at Wake Forest University, and a master’s of science from North Carolina Agricultural and Technical State University.
  • Mehdi Yazdi, Ph.D., Director of Quality Control and Analytical Services: With a doctorate from the University of Mississippi, Mehdi Yazdi is focused on improving PCI’s entire Quality Control and Analytical Development function. In his short time at PCI Synthesis, Dr. Yazdi has been instrumental in revamping the entire department, including improving training, ensuring consistency, building an analytical development team that has significantly improved outcomes. He joined the company from Clariant Life Science Molecules, where he was served as QC Manager; prior to that he was with DPT, responsible for the analytical development of both large and small molecule finished dosage forms.
  • Don Dickison, Director of Business Development: With a successful career in pharmaceutical sales and sales management, Don Dickison is responsible for the day-to-day business development activities for fine and specialty chemicals including emerging Pharma. His prior experience includes posts at PRS Pharma and almost a decade and a half with Eli Lilly in various sales and sales management roles. Dickison holds a bachelor’s degree from the University of New Brunswick.
  • Paul Nichols, Ph.D., Director of cGMP Kilo Lab: In this role, Paul Nichols is responsible for early phase clinical drug substance development and manufacturing for PCI’s’ clients. Dr. Nichols comes to the company after several years at Array BioPharma, where he held the position of Senior Research Investigator. Before that, Dr. Nichols worked at Abbott Labs as a Research Scientist. He earned a doctorate from the University of Colorado at Boulder, a master’s of science from San Diego State University and a bachelor’s degree from the University of California at San Diego.

These new hires are part of PCI Synthesis’ strategic initiative that has included the completion of major expansion of the company’s Devens, Mass Research and Development facility. The expansion, which was completed last month, includes several new research hoods, analytical instruments, additional support equipment, additional staff, and a major expansion to the site's existing kilo lab capacity, was initiated to support PCI’s expanding activities in early- and late-stage clinical candidate programs. Since September 1st, the company has brought on board 20 new staff members in several functional areas to further support its growth in development of new compounds.

All together the additional staff and capacity enables PCI to offer its biotech and pharmaceutical customers a bridge from lab scale development to commercial manufacturing. This represents an important intermediate step as customers work on new compounds for new therapies, conduct clinical trials and seek to bring products to market. The 30-percent capacity increase positions PCI to handle increased customer demand. Part of the expansion was driven by a new collaboration agreement with Biogen Idec to work closely with its process research group to augment its internal small-molecules capabilities and optimize a number of new compounds.

Norman Birnbach

Birnbach Communications, Inc.




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