Christopher M. Leblanc

christopher leblanc pharma qa and qc consultant bio pharma consulting group

Founder & Principal Consultant

Christopher LeBlanc is the founder and Principal Consultant of BioPharma Consulting Group, LLC, a patient passionate, innovative consulting agency that provides quality services to the biotechnology, pharmaceutical and biologics industries.

He has over 15 years of industry experience in cGMP operations, quality control (QC), quality assurance (QA), systems, validation, and analytical development. He has held quality chemist and leadership positions at several pharma/biopharma companies. At the beginning of his career as an analytical chemist, Chris was involved with analytical method development and validation while working for Avatar Pharmaceutical Services, a start-up company at the time, and contract research organization (CRO).

The last 10+ years he has worked for large corporation start up sites including Lonza, a contract manufacturing organization (CMO) and Novartis in Singapore. He was responsible for and assisted with establishing quality control departments, leading quality control teams with method development, transfers, validations, new equipment qualifications, calibrations and validations, designing and overseeing QC sample management workflows, result release and sample disposition processes, quality systems implementation and management, setting up and executing stability programs, conducting internal audits and participating in external customer and regulatory audits.

At Lonza Singapore, Chris participated in frequent inspections/audits including on site customer and regulatory inspections by United States (FDA), Europe (EU), Japan, Brazil and Turkey. In addition, he contributed to the successful regulatory audits at Novartis Singapore which resulted in the granting of the sites GMP Manufacturing certificate by the Singapore Health and Sciences Authority (HSA), Singapore’s Regulatory Agency, and approval for manufacturing and distributing a commercial Drug Substance/Product to the European Union by the European Medicines Agency (EMA).

Education
Chris holds a Bachelor of Science degree in Chemistry from Worcester State University, and a Master of Science degree in Analytical Chemistry from the University of Massachusetts.

Biotech & Pharmaceutical Consulting Services

Quality Control

Our Quality Control Consultants will follow and establish well-defined controls through procedures bringing value to our clients by meeting the product quality needs and expectations at every step from development to commercial final product release.

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Quality Assurance

Our Quality Assurance services focus on improving quality, integrity and compliance by providing certainty of the product and data. Guaranteeing effectiveness and efficiency as per client expectations and regulatory requirements with regard to patient safety.

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Project Management

BCG will manage client projects with technical competencies focused on quality design efficiency through customized strategies to meet all company goals and produce completed projects compliant to objectives and timelines.

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WHAT OUR CLIENTS SAY

Chris’s work ethic and style assure the achievement of a company’s diverse objectives.

In South East Asia, Chris worked for 2 global pharmaceutical companies, both seeking managers interested in working overseas. Each company wanted a proactive approach to promoting diversity and inclusion in business operations and workflows. He added value by providing international experience and innovative thinking practices. In working successfully with people from around the world, he gave each company a cutting-edge advantage in work policies and platforms.

Chris provided his Quality expertise and developed partnering relationships by adapting to the different work and social cultures of each company. He leveraged his experience with various pharma companies and regulatory agencies to the successful application of best practice approaches throughout all Quality Control/Assurance processes.

International Experience

Chris is a great Quality Lead for any start-up life sciences company.

Chris has worked for several bio/pharma start-up companies. In some cases, the Quality laboratories did not have any equipment, or the business site had not experienced their first audit. He was responsible for building Quality Control/Assurance departments, determining organizational structure, hiring teams and product manufacturing planning. This resulted in successful regulatory audits to obtain GMP manufacturing certificates, site commercial manufacturing, and approval to distribute medicinal products to targeted markets.

Start-up companies always face the challenge of working with limited resources. In start-ups, Chris assisted with hiring general contractors to perform all new equipment purchasing, intake, IQ/OQ/PQ, and he managed equipment calibration timelines, with QC/QA oversight and approval of all contractor activities. In addition, he contributed to hiring FTE laboratory personnel to establish essential laboratory workflows and processes such as 6S, Kanban, housekeeping, glass washing, gowning, storage unit alarm response, sample management and quality systems (deviations, investigations etc.). He also created lab work instructions (SOP’s and Protocols), enabling the companies to perform transfer work once new equipment were GMP released for use and prepared for commercial manufacturing.

Start-Ups with Limited Resources