Who works at the bmc
Our experts: a look at our departments?
Production
At the heart of BMC operations is a highly technical manufacturing team structured in four (4) areas: upstream, downstream, media/washing sterilizing and filling/packaging.
This skilled and seasoned team with extensive expertise is responsible for all the steps of manufacturing and allows the BMC to act as a real one stop shop: from growing cell cultures to purification of the drug substance and aseptic fill and finish.
With the support of cross functional teams (QA, QC, Supply Chain, Facilities Engineering), this industry-leading team thrives to deliver the highest quality product and executes all manufacturing activities by rigorously following GMP standards.
A key part of this team are the Manufacturing science and technology experts who support and guide these complex biologics processes from scale up to on-going manufacturing assistance.
Quality Assurance and Compliance
At the BMC, quality is built in at every step, into every process, at every level, and by design, it is everyone’s responsibility.
The quality assurance (QA) team ensures compliance and adherence to regulatory GMP guidelines by integrating quality management system elements in all GMP activities performed at the BMC.
The QA team oversees all BMC operations related to premises, systems, equipment, utilities, materials, products, processes, and testing including review, approval, and/or authorization of all quality related data, documents, and records.
This team is critical in ensuring your GMP activities are accomplished by trained personnel and according to current effective standard operating procedures (SOPs). They develop quality metrics that lead to continuous process improvement, and they guide the BMC into sound quality risk management.
Quality Control
The Quality Control team is a comprised of result-oriented industry experts in Biochemistry and Microbiology with the capacity to deliver complete analytical packages from method development and validation up to stability studies for in-process control/testing, and release of Drug Substance (DS)/Drug Product (DP) as well as Raw material and packaging method verification and release testing.
Our experts are well-versed in comparability studies along with critical environmental monitoring and cleaning validation support.
This team also includes a logistics department, whose primary responsibility is to ensure the quality control lab itself consistently meets GMP requirements.
Facilities & Engineering
The Facilities & Engineering and Facilities Department at the BMC is responsible for providing a wide range of services related to the maintenance and calibration of production and laboratory equipment, as well as the maintenance of the campus facility including the BMC building and utilities. We work closely with various stakeholders including production, quality control laboratory and warehouse staff, and administrators to ensure that our facility provides a safe, efficient, and productive environment for everyone.
The Facilities & Engineering team is composed of highly skilled and experienced professionals and engineers in the fields of project management, engineering, and facilities operations. We pride ourselves on our ability to take on complex projects and deliver them on time. Our activities include planning, design and maintenance of buildings, grounds, and utility systems on site.
We are continuously looking for ways to enhance the quality of our facility while being mindful of our impact on the environment and generated products. We work on delivering the projects on time and we make sure to execute all the tasks under GMP standards and pharmaceutical compliance.
Supply Chain and Warehouse
The Supply Chain and Warehouse team are recognized for their agility to ensure an “end to end” material flow tailored to our client’s requirements. With expertise in purchasing, supplier management, demand forecasting, warehousing, supply planning, and inbound/outbound logistics, the team thrives at every stage of the supply chain.
The Supply Chain team has key performance factors to achieve the highest level of reliability, flexibility, and resource management within our manufacturing processes to consistently supply the highest level of quality to our clients.
Other experts and supporting roles
The team at the Biologics Manufacturing Centre also includes experts in Information Technology & Automation:
- Health, safety and environment – to provide expert technical information, monitoring, reporting and advisory services
- Manufacturing science – to provide scientific and technical support
- Project management – to track and report on all required activities
- Technology transfer – to collaborate with clients on planning and executing technology transfers for each specific client project