Industry professionals earn ISPE-PCC credential

Timothy Howard, Robert Lechich and Allan MacDonald have met the global competency standard and have been conferred the Certified Pharmaceutical Industry Professional (CPIP) credential by the ISPE Professional Certification Commission (ISPE-PCC). They are three of 12  professionals to be awarded this new certification and were assessed through demonstrated education, industry experience and a rigorous examination. The credential offers the first competency-based international certification for pharmaceutical professionals and covers a range of competencies from drug product development through manufacturing.

The new certification offers enhanced credibility, peer respect and recognition, and greater opportunities for professional advancement.

Howard is a regulated services business lead for Commissioning Agents Inc., providing C&Q program consulting and project planning services. Previously, he spent 3.5 years with Eli Lilly at a greenfield site and was responsible for leading the C&Q effort and the maintenance and facility engineering group. An ISPE member since 1994, Howard’s service to the society includes serving on the ISPE Task Team that developed the ASTM standard E2500, acting as chairman of the Carolina/South Atlantic (CASA) Chapter membership committee, and serving on ISPE’s International Education executive committee in 2007 and 2008. Howard is currently the chair of ISPE’s North American education committee, having served on that committee since 2002, and is a CASA chapter board member. He is a qualified trainer for the ISPE training course on C&Q Applications, speaks regularly at conference seminars, and is published in Pharmaceutical Engineering magazine. He is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. Howard earned a bachelor of science degree in mechanical engineering from North Carolina State University and is a registered Professional Engineer in North Carolina.

Lechich is currently the operational excellence manager in the Biotech External Supply organization of Wyeth Pharmaceuticals focusing on contract manufacturing pharmaceutical and biotechnology industries and has worked in many areas including manufacturing, quality assurance, process engineering, facilities engineering and management, automation and information systems, and supply chain management. He holds a bachelors degree in chemical engineering and a masters degree in technology management from Stevens Institute of Technology in Hoboken, N.J.; as well as a certificate in supply chain and logistics from Georgia Institute of Technology in Atlanta. Lechich is currently a doctoral candidate in information management and lectures in business process management and supply chain information systems at Stevens Institute of Technology. In addition to being a certified Six Sigma black belt, he holds certifications in project management, production and inventory management, and supply chain management.

MacDonald has more than 25 years of experience in the pharmaceutical industry. He is currently an independent contractor providing engineering support for bio/pharmaceutical companies in the Boston area. His experience includes engineering and operations with pharmaceutical companies, an architectural and engineering firm, and an equipment manufacturer. MacDonald has held positions at Alkermes, Fluid Air, Parsons,Therion Biologics and Wyeth. He served on the ISPE Boston chapter’s board of directors for two years and co-chaired the bulk pharmaceutical chemicals discussion forum (formerly SIG) for four years. His article, “Do You DQ?,” appeared in the March 2005 issue of Pharmaceutical Engineering magazine. MacDonald holds a bachelors degree in chemical engineering and a certificate in management from McGill University in Montreal.

To learn more and obtain a CPIP eligibility application (free download) visit www.ISPE-pcc.org.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Fla.; its European office in Brussels, Belgium; its Asia Pacific office in Singapore; and its newly established office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.

About the ISPE-PCC and Certified Pharmaceutical Industry Professional (CPIP)
The ISPE Professional Certification Commission (PCC), an autonomous governing body within ISPE, develops certification programs to benefit credential holders and their employers, as well as government, academia, and the public health product consumer. The PCC is composed of 12 commissioners, including senior-level industry professionals representing Argentina, Australia, Japan, North America, and the United Kingdom, as well as academia, the US Food and Drug Administration (FDA), and the general public.

The Certified Pharmaceutical Industry Professional (CPIP) credential represents an international competency standard in both knowledge and skills. For those professionals with less than seven years of experience, the certification can be used as a professional development pathway to build a bridge from academia to the intricate business of developing drug products and bringing them to market through manufacturing. For those with more than seven years of experience, the CPIP credential is a solid testament to accumulated experience, knowledge, and the ability to apply innovative thinking and solutions.

Employers who require contemporary pharmaceutical industry knowledge and skill competencies from their employees turn to CPIP to confirm competency based on a global industry standard. Service and equipment providers have proposed CPIPs on their project teams to confirm that they have the most qualified staff. In short, the CPIP credential is all about competency; having it, validating it, maintaining it, and leveraging it for the benefit of one’s self, one’s employer, and the progression of the pharmaceutical industry.

Visit www.ISPE-pcc.org for additional certification information.