Biologics Manufacturing Scientist

Requisition Number: 74703

The company built on breakthroughs. ​  
Join us.​          

Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible.  ​  

How do we do this? With our people. They break through limitations and expectations – not once in a career, but every day. They help move our company, and the world, forward. ​  

​At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more.​   

​Come break through with us.  

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.

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 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.

Required Education:

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

Required Years and Area of Experience: 

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

Required Skills: 

• 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).

Day to Day 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.

Travel Requirements:

• Negligible

Hours of work/work schedule/flex time:

• Standard business hours; Monday – Friday; at least 40 hours/week; availability to provide weekend advisement as needed. Prefer hours of 8:00 am – 5:00 pm.

Desired Experience / Qualifications / Skills:

• 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

Soft Skills:

• 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.

This position does not support immigration sponsorship.  

The range for this position is $70,776.00 - $97,317.00  assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education. 

A job that shapes a life.  

Corning offers you the total package.  

We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.

Corning is committed to providing equal employment opportunities and considers requests for reasonable accommodations in accordance with applicable laws. Individuals with disabilities or sincerely held religious beliefs may request reasonable accommodations to participate in the application or interview process, perform essential job functions, or access other benefits and privileges of employment. To submit a request for reasonable accommodation related to disability or religion, please contact us at accommodations@corning.com.