Biologics Manufacturing Scientist

Corning•Bedford, MA

8d•Onsite

About The Position

As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries. 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 be supporting 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.

Requirements

Bachelor’s degree in Biological Sciences or Biomedical / Chemical / Bio-related Engineering or Biotechnology degree.
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, to include 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 processes) 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).

Nice To Haves

Knowledge of lab equipment validations.
Knowledge of documentation and documentation procedures.
Six Sigma Green Belt certification
Lean green belt certification
Project Management experience
SAP / EtQ or similar MRP/Quality systems
Lab manufacturing / engineering experience
Clear communications skills, both written and verbal, and ability to present data and findings.
Must be action and detail oriented, possess excellent organizational and problem-solving skills.
Effective people skills; team-oriented individual.
Must be able to work independently and prioritize and multi-task projects.
Flexible – may need to come outside of work timings including weekends.

Responsibilities

Provide day-to-day production / continuous improvement support toward attaining plant goals and objectives in the areas of quality, cost, safety, and waste.
Will act as a team member to support the development and execution of plans to evaluate new manufacturing processes or improvements in existing manufacturing processes.
You will be assuring the quality and repeatability of processes and products.
Identifying, justifying and implementing cost reduction, capacity enhancement, capital equipment, and other improvement initiatives
Designing and/or specifying new equipment (semi-automated / automated) or modifying existing equipment to continuously improve process performance
Lead validation projects working in a cross-functional team. Coordinating installation, debugging and initial operation of new and existing equipment.
Developing in-depth knowledge of material, processes and/or equipment in focused areas of manufacturing or engineering by process observations in 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 multi-disciplinary team with Operations and Quality to resolve technical problems, analyze manufacturing capability, anticipate major problems to key operations and implement manufacturing changes when necessary.
Utilizing continuous improvement tools to improve productivity and lower standard product cost.
Function as Subject-Matter-Expert in process control/discipline, 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 product release.
Support GSM with identification/analysis of raw materials to avoid supply disruption
Executing cost reduction and improvement (DMAIC & LEAN) projects in line with business objectives. Provide updates to the site & senior leadership. Performs investigations and analysis activities in support of resolution of failures, contamination events, etc.
Training production associates on improvements; observations; findings; best practices; new equipment and processes on a regular basis.
Any other tasks assigned by plant operations management.