Biologics Manufacturing Scientist

Scope of Position

In this role, you will be determining and implementing permanent solutions to performance issues, and improving existing and new technologies and processes, using statistical tools and DOE techniques in problem‑solving and process/product improvement. This hands‑on position will involve documentation and presentation of data and findings, statistical data analysis, and collaborating with cross‑functional team members. You will ensure product claims are met by supporting new or existing products or processes, contamination control, process improvements and product manufacturing through release.

You will support new product introductions through equipment installation, process validation, documentation, and training; providing technical expertise to determine the root cause of issues and put permanent solutions in place. We look for you to lead or support efforts to identify and troubleshoot process, material, or lab instrument problems to minimize production schedule delays and improve yield. We look for you to provide disciplined project direction across multiple stages of innovation for new product, process, cost reduction, capital and capacity improvement initiatives.

Bachelor’s degree in Biological Sciences or Biomedical / Chemical / Bio‑related Engineering or Biotechnology.

Minimum 3 years lab experience within the life sciences or pharmaceutical industry.

• Experience with biological manufacturing processes including cell culture, protein purification, extra‑cellular matrix, lyophilization, centrifugation and vialing.
• Proficiency within the laboratory, including aseptic/sterile technique, recording data, problem‑solving and analytical data skills.
• Problem‑solving techniques to own and perform investigations.
• Experience working in a regulated environment and/or under a quality management system such as ISO requirements, GMP (good manufacturing practices) or GLP (good laboratory practices).
• Experience providing technical feedback to engineering and operations staff; proven experience working on cross‑functional teams.
• Experience with continuous improvement methodologies and tools including LEAN (5S/Kaizen/Kanban & others), DMAIC, SPC, DOE and product/process validation (IQ, OQ and PQ).

• Provide day‑to‑day production / continuous improvement support toward attaining plant goals and objectives in the areas of quality, cost, safety, and waste.
• Act as a team member to support the development and execution of plans to evaluate new manufacturing processes or improvements in existing processes.
• Assure the quality and repeatability of processes and products.
• Identify, justify and implement cost reduction, capacity enhancement, capital equipment, and other improvement initiatives.
• Design and/or specify new equipment (semi‑automated / automated) or modify existing equipment to continuously improve process performance.
• Lead validation projects in a cross‑functional team, coordinating installation, debugging and initial operation of new and existing equipment.
• Develop in‑depth knowledge of materials, processes and/or equipment in focused areas of manufacturing or engineering by process observations in the lab and exploring technology for process improvements, thereby becoming subject‑matter expert for key product lines.
• Schedule and coordinate project activities to align with cross‑functional team deadlines and budgets.
• Work in a multidisciplinary team with Operations and Quality to resolve technical problems, analyze manufacturing capability, anticipate major problems, and implement manufacturing changes when necessary.
• Utilize continuous improvement tools to improve productivity and lower standard product cost.
• Function as subject‑matter expert in process control, SPC, SQC, OEE, Design of Experiments, and other performance‑excellence processes.
• Execute laboratory studies to aid in improved product concepts.
• Document studies and perform data analyses to draw scientific conclusions.
• Develop protocols for use ensuring quality and regulatory compliance.
• Support Quality with NCM investigations and justification of…