cGMP Bio -Manufacturing Engineer

Full-time - Mid Level

Melville, NY

Miscellaneous Manufacturing

About the position

BioRestorative Therapies, Melville, NY is recruiting for a cGMP bio-manufacturing engineer. This role provides outstanding opportunities for talented self-motivated individuals, ideally with experience in (stem) cell biology, immunology, and/or molecular biology, who can contribute to our ongoing efforts to generate clinical grade cell-based therapeutics. We are most interested in connecting with qualified individuals who aspire to support the development of therapeutics and/or life science products and tools to support research endeavors.

Responsibilities

• 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.
• 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 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.

Requirements

• 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.