President, PSC Europe
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Heather Kelly comes to PSC Biotech Corporation as an experienced senior director across engineering sectors with over 20 years dealing with complex technical and legal issues combined with analytical and technical knowledge, fiscal responsibilities, conflict resolution, software, CAPA, non-conformance regulatory compliance, manufacturing, six sigma and global business startups.
As a leader in engineering and biochemistry fields, project management, and global organization experience Heather spearheads PSC’s efforts in Europe. She holds certifications such as GMS CRP ERC visa and immigration expert, audit quality appraisal and delivery, project management professional, advanced sciences, among others. With Heather’s background, we expect to continue to prosper in Europe and beyond.
President & CEO
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John has more than 29 years of experience working hands-on in the life science industry. Prior to founding PSC Biotech Corporation, he worked for the United States Department of Defense (Naval Ordnance Station), CPI Plants Inc., Lockwood Greene Engineers, Johnson and Johnson and Fluor Daniel and has a bachelor’s of science in chemical engineering from the University of Rhode Island.
John is a former Past President of the International Society of Pharmaceutical Engineers (ISPE) Los Angeles Chapter. He is also a member of the Parenteral Drug Association (PDA), American Society of Quality (ASQ) and Regulatory Affairs Professionals (RAPS). He is passionate about value creation for his clients in the field of life science.
Zhu Hong Chong
Managing Director, Asia
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Zhu Chunhong has more than 23 years of experience in the chemical engineering, pharmaceutical and biotechnology industries. She specializes in qualification, validation and cGMP compliance services to pharmaceutical and biotechnology plants, which includes laboratory, manufacturing facility, equipment and utilities. Her experience in validation and cGMP compliance ensures her team is directed by expert management. She has successfully supported four sterile injectable Chinese domestic manufacturers achieve marketing authorization for their sterile injectable cephalosporin products and led two green field commissioning and qualification projects in Singapore for sterile facility and biotechnology facility. We only expect her skillset to spearhead PSC Biotech Corporation’s growth in Asia.
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Davy Mao comes to PSC Biotech Corporation with over 20 years of experience in biotechnology, pharmaceutical processes, engineering, information technology, business development, portfolio management and operational management. Davy has played an instrumental role in PSC Biotech Corporation’s growth and success. He is a dependable leader, with proven track record, who leads by example. He enjoys mentoring and building successful individuals and teams. Davy holds a bachelor of science degree in biomedical and biochemical engineering from the University of Southern California.
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Gilbert Wong has over 30 years of experience in finance management specific in planning and control, developing financial policy, implementing management reporting systems, and finance and accounting management. Gilbert joined PSC Biotech Corporation as Controller in 2008 and promoted to Chief Financial Officer in 2011 to lead the finance and accounting function for PSC group. He is responsible for managing the group’s finance and accounting, planning and control, business investment, treasury, and tax planning.
Gilbert has an extensive track record in setting and driving the company to achieve the financial goals, risk management, and directing the finance and accounting functions to meet with required accounting standards and the legal compliance. Gilbert holds an masters of business administration, a CPA from the Hong Kong Institute of Certificated Public Accountants, a CPA from the Washington State Board of Accountancy, and was a FCCA from the United Kingdom Association of Chartered and Certified Accounts. Gilbert is located at PSC’s headquarters in Pomona, California.
Dr. Charles’s Heldebrant
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Charles Heldebrant, Ph.D. has over 40 years of experience in biological and pharmaceutical product development, regulatory affairs, quality systems, process design, equipment and process validation, nucleic acid based diagnostics, analytical methods validation and computer validations.
Dr. Heldebrant is responsible for the entirety of PSC Biotech Corporation’s scientific and quality systems worldwide. He has performed numerous compliance, gap assessment and mock agency audits for foods, drugs, biologics, medical devices, botanicals and nutritional supplements throughout the world. He has conceived, developed and licensed biologic products; designed, executed and reviewed process validation studies and programs for biologic products and processes; prepared successful biologic license applications, new drug applications and investigational new drug applications; inspected, taught and validated aseptic filling of monoclonal antibodies and terminally sterilized emulsions; designed and operated stability studies and programs; and validated viral inactivation processes and medical devices; and provided quality assurance for contract manufacturing and software organizations. Dr. Heldebrant embodies the integrity and leadership of PSC.
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Justin has been a part of the PSC Biotech Corporation leadership team for over 5 years, based out of the Pomona corporate headquarters and supporting clients throughout Southern California. Justin develops new business, oversees client accounts, directly manages projects, and mentors personnel. In addition, Justin helps to guide and implement PSC’s strategy for continuous expansion and improvement.
Prior to joining PSC, Justin held successive leadership roles in operations departments of companies such as Gilead Sciences, Alpha Therapeutics, and Genentech as part of a 25+ year career in the life science industry. His experience managing large capital projects at Gilead Sciences’ San Dimas facility as been instrumental to his success with PSC, and his background in manufacturing has provided a strong knowledge base that has been leveraged to the benefit of PSC’s clients.
Justin remains heavily involved in the Los Angeles chapter of ISPE as a past President, now supporting programs and social media activities. He has an masters in engineering in pharmaceutical manufacturing from Stevens Institute of Technology, and a bachelor’s of science in chemical engineering from Michigan State University. Justin is an avid reader and is learning how to play guitar (which his wife and kids hope he gets better at very quickly).
Director, Business Development & Operations
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Brandon Clough has over 20+ years of experience in both Quality Assurance, Quality Control and Production in Life Science, Biotech, Personnel Care, and Animal Health industries. While at MilliporeSigma (formerly Sigma-Aldrich) Brandon managed the Corporate Auditing team (100+ people) which performed external and internal audits. He was involved in evaluating the health, compliance, and process improvements at multiple Sigma-Aldrich sites. He performed due diligence audits of potential accusation targets and was key in the integration of newly acquired sites. While at Huvepharma, Brandon managed the operations of 3 US manufacturing sites focused on animal drug development and production. The Huvepharma sites produced API’s, finish solid dose drugs, liquid drugs, and vaccines. Brandon holds a Bachelor of Science degree in Biology, a Bachelor of Arts degree in English, and a Master’s Degree in Business. He also holds Certifications from the American Society of Quality in Certified Pharmaceutical GMP Professional (CPGP), Certified Manager of Quality Organizational Excellence, and Certified Quality Auditor. He participated in authoring the second and third exam for Certified Pharmaceutical GMP Professional (CPGP). Brandon has hosted over 27 FDA inspections, 3 MHRA inspections, 2 AFIA inspections, 3 EPA inspections, 2 OSHA inspections, and 4 Board of Pharmacy inspections. He is also a trainer on process improvements and operational excellence as a certified Advance Program Improvement leader. He is currently on the committees of Parental Drug Association (PDA) International Working Group, International Society for Pharmaceutical Engineering (ISPE) Women in Pharma mentorship program, and the St. Louis American Society of Quality mentorship program.