Providing cloud-native, highly configurable, enterprise quality management systems
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One Centralized, Secure, and Organized Location for All of Your Business's Documents
Keep Training Up-To-Date with ACE LMS®
Schedule, Plan, and Execute Audits for Suppliers, Vendors, and More to Ensure High Quality Production.
Be Proactive and Prepare Your Company for Potential Risks.
Stay Prepared for Inspections Any Day, and Any Time.
Handle All Quality Events in One Place While Keeping All Records Organized.
Manage Your Clinical Trials and Track Your Milestones with Ease.
PSC Software® provides software products and solutions to best fit your company's needs.
PSC provides a wide range of professional services including auditing, technical writing, engineering, metrology and calibration, and much more.
PSC serves all companies in highly regulated industries.
At PSC Software®, we are passionate about providing innovative software solutions that empower businesses to achieve their full potential. With a dedicated team of experts and a commitment to excellence, we have established ourselves as a leading provider of cutting-edge software solutions in the industry.
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.
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.
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.
Justin Jay comes to this role after serving as PSC Biotech’s East Coast Director of Technical Operations. Overall, he brings more than 20 years of operations and business development experience in the private and public sector to his role as Chief Operating Officer of PSC Biotech.
With a career devoted to life science, Justin has first-hand experience in almost every aspect of the business – from research and development to clinical project management to manufacturing operations to commercial oversight. His diversified background, entrepreneurial spirit, and agile adaptivity allow Justin to deliver operations leadership, sales management, strategy, and innovation that optimize projects of all sizes, complexity, and duration for success.
As an operations and business development executive, Justin brings skills and experiences that align well with PSC Biotech’s priorities – spearheading and executing time-sensitive clinical and commercial manufacturing initiatives for global pharmaceutical, biotechnology, and medical device organizations.
His past work in the life science industry includes serving as a project and portfolio management leader for global biologics manufacturing sites, directing late-stage drug development projects for major global pharmaceutical companies, and designing project management infrastructures that seamlessly incorporate into larger global development planning efforts.
An adept cross-team facilitator with a successful track record in developing, optimizing, and scaling projects and technologies, Justin’s background is making a significant contribution to helping PSC Biotech work effectively under aggressive timelines, challenging logistics and complex requirements.
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.
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.
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).
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.
Gilbert leads PSC Biotech Corporation’s technology capabilities through the division PSC Software™. He is responsible for both the oversight of product development as well as directly developing all cloud-based applications, and additionally, leading the strategic planning of all application hosting capabilities. Bringing over 15 years of expertise across many development platforms, Gilbert has a wealth of technical knowledge and skills. Gilbert graduated with a bachelor’s of science in business administration from California State Polytechnic University, Pomona. PSC Software™ continues to grow year after year under Gilbert’s expertise, and we plan to see this trend continue.
Thomas Tschirhart is the Head of Sales at PSC Software®, responsible for driving the company’s sales strategy and leading a high-performing sales team. With a proven track record in sales and a deep understanding of the software industry, Thomas plays a vital role in driving revenue growth and establishing strong customer relationships.
With over a decade of experience in sales and business development, Thomas has a keen understanding of the challenges and opportunities in the software market. His strategic mindset, combined with his strong leadership skills, allows him to align sales efforts with the company’s overall objectives and deliver exceptional results.
Thomas is known for his ability to build and nurture long-term partnerships with clients. By thoroughly understanding their unique needs and requirements, he ensures that PSC Software®’s solutions align with their goals and provide maximum value. His customer-centric approach fosters trust and confidence, making him a trusted advisor to clients across various industries.