- Perform laboratory work in a cGMP setting, primarily working with adult cell culture (MSCs) and differentiation, following bio-manufacturing procedures and manufacturing schedules to facilitate on-time delivery of high-quality finished products for clinical use.
- Previous experience in clinical-grade cell line development and Master Cell Bank management.
- Assess existing manufacturing site and equipment to identify improvements to facility and equipment to meet safety, quality, production and cost goals. Apply knowledge gained towards the designing, planning and building of future manufacturing sites.
- Lead the design, specification, commissioning and qualification of the building, equipment, and utilities.
· Responsible for project planning and accountable for costs and timelines and project delivery.
· Influence across departments (Research and Development, Process Development Engineering, Facilities, Quality Assurance and Quality Control) in the completion of projects.
· Reduce costs by investigating alternative equipment to improve efficiency, quality and yields in bottleneck areas.
· Liaise with the Process Development and Manufacturing teams in the transferring, and validation of new products into the manufacturing areas. Support design activities with business cases including economic analysis.
· Support daily production and assist in troubleshooting utilities and equipment.
· Write technical reports, facilities and utilities design specifications and protocols compliant with BioRestorative’s quality management system.
· BSc degree in cell biology or similar discipline with 2 to 8 years of industrial experience or a MSc with 1 to 6 years of industrial experience.
· Experience with current good manufacturing practices (cGMPs) in a regulated industry complying with 21 CFR part 210, 211 or 820.
· Excellent understanding of pharmaceutical manufacturing, aseptic technologies, facilities, utilities and equipment qualification and process validation.
· Extensive knowledge of flow (people, material, waste) improvements and optimization.
· Must be highly motivated, have excellent interpersonal and teamwork skills, be highly independent, and have effective organizational and verbal and written communication skills.