• Home
• Collaborations
• Biopharmaceutical manufacturing

Biopharmaceuticals: Business Structure

Our mission is to be GSK's Biopharmaceutical Manufacturing Center of Excellence enabling GSK and its customers to launch, supply and manage Biopharmaceutical products around the world.

We will use our experience and capabilities to deliver a diverse product portfolio of biopharmaceutical products, maximizing value for GSK and its customers.

Departments

• Administration
• Biopharmaceutical Technology
• Engineering Operations
• Manufacturing
• Quality Assurance and Control
• New Product Introduction
• Validation

Administration

From recruitment to financial management to purchasing material, the areas in this function help to support the day to day operations. Business areas include:

• Finance
• Business Development
• Human Resources
• Procurement
• Materials and Logistics
• Warehousing
• Operational Excellence
• Safety & Environment

Biopharmaceutical Technology (BPT)

BPT provides the following:

• Technical transfer documents, sample matrix, bill of materials
• Draft batch record preparation
• Tech transfer/scale up studies: mixing and mass transfer, hold studies, performance and cleaning, media qualification, aseptic qualification, process qualification
• Manufacturing Support: Troubleshooting, product impact assessment, process improvements, control charting process performance
• Development Laboratory: Process demonstration, scale-down studies, process improvements and troubleshooting

Engineering Operations (Eng-Ops)

Eng-Ops provides the following:

• Engineering technical services to maintain the facility, utility systems, computerized controls and process equipment in a fully ready and cGMP compliant state
• Validation function - Equipment validation (IOPQ's) for all process, support and utility systems
• Supporting the NPI team in the design and execution of capital projects for processing areas by providing equipment and automation control system engineering resources

Manufacturing

Manufacturing areas include:

• Cell Culture and fermentation - Seed lab and bioreactor operations, production bioreactor maintenance and harvest operations
• Purification - Utilizing different purification methods to separate out the desired protein (Ultrafiltration, Diafiltration, Chromatography etc.)
• Support Services - Preparation of the media/buffers, and sterile preparation of equipment.

Quality Assurance (QA)

QA provides the following:

• cGMP Training, Documentation Control
• Process Samples Management, Batch Records Review
• Product Disposition, Raw Materials Disposition
• Investigation/CAPA, Change Control
• Validation Approval, Internal/External Audit

Quality Control Laboratories (QCL)

QCL provides the following:

• Microbiology - In-Process/final product testing, Environmental/ personnel monitoring, Utility monitoring, Validation samples testing
• Biochemistry - In-Process testing, Sampling and inspection of Raw Materials, Components, Utility monitoring (chemical), Validation support

New Product Introduction (NPI)

NPI provides the following:

• Establishment of the critical goals of the transfer by working with clients early in the project
• Project management for the transfer of internal or external products into the sites for manufacturing
• Delivery on agreed timelines and budgets

Typical role descriptions in US Bulk manufacturing facility

Below are some of the types of jobs that make up our day to day operations.

Biopharmaceutical Manufacturing Associate - Prepare growth media, buffers and other solutions used in production processes. Conduct manufacturing operations in compliance with cGMP. Support start-up, validation of the facility. Prepare and sterilize process equipment. Clean equipment and maintain area in clean and orderly fashion.

Production Supervisor - Responsible for development and revisions of batch records and standard operating procedures. Ensures timely delivery of scale-up and manufacturing activities. Provides technical support to process and assists in selection and/or development of process equipment and raw materials.

Associate Manufacturing Specialist - Assist with the development of technical programs for new manufacturing associates. Assist with the development and co-ordination of cGMP and safety training programs for the supervisors to deliver. Assist with the planning of production schedules for all three major unit operations at the site. Assist with non-inventory item management. Co-ordinates validation activities in the manufacturing areas to ensure minimal interruption to routine operations. Co-ordinates maintenance activities in the manufacturing areas to ensure minimal interruption to routine operations. Fill in as Supervisor.

Engineer - Provide engineering and technical support for instrumentation and control systems in the Biopharmaceutical Operations facility. Evaluate and develop technology, plan and implement modifications and upgrades to control systems, and provide technical support.

Validation Engineer - Hands-on responsibility for equipment and facility validation projects; writing validation protocols, completing data sheets, scheduling and performing validation tests, gathering and analyzing data, and writing final validation reports. Represent validation issues on project teams. Lead specific validation projects.

Senior Technology Associate - Responsible for providing support to production by assuring technologies are properly transferred to operations and by providing technical know how as needed for training, procedure development and problem resolution. Also responsible for providing technical leadership in identifying process problem areas and devising resolutions. The Senior Technology Associate is also responsible for devising process improvements and technology implementation strategies and overseeing scale-up activities and process introductions to the plant.

Senior QA Coordinator - Issue, track and review completed Batch Production Records, conduct internal and external audits, perform data collection and trend analysis, and assist in the training program.

For current job opportunities go to www.gsk.com/careers.