Manufacturing Science & Technology Scientist- Research Triangle Park

The Manufacturing Science and Technology Scientist is responsible for ensuring the successful transfer and continued technical support for the company’s processes in order to meet established timelines and quality objectives.  Will work with Manufacturing, Research and Technology (R&T), Project Management, Marketing, and Quality to successfully transfer processes and systems into Manufacturing.

Primary Responsibilities:

• Perform all functions associated with process transfer and scale up to manufacturing, e.g. develop process understanding, perform gap analysis/FMEA, generate process models, author/review Process Descriptions and Batch Records, support equipment commissioning, process training and validation activities.
• Participate in site safety awareness programs as applicable.  Example: site training, safety committee or ergonomics team.  Educate and train manufacturing personnel on process safety.
• Assist with evaluation of process requirements to ensure facility and equipment capability design can accommodate.  Perform calculations to predict volume, time and yield projections.  Assist with evaluation of new proposals from prospective customers.
• Provide process equipment troubleshooting to resolve issues that may arise during a manufacturing campaign.  Initiate and drive equipment utility change controls to ensure equipment is implemented or repaired within required timeframes. 
• As needed, interface with customer technical and quality representatives, represent MSAT group in Project Teams
• Work directly with Manufacturing, Project Management, Marketing, Supply Chain and R&T and Marketing to develop a bill of materials, to assist in part set-up and write the transfer documents as needed for an incoming process.
• Perform all functions associated with process monitoring and lot releases e.g. manufacturing data summary and analysis, data presentation; author campaign summary reports, assess deviations and process changes. 
• Play a key role in resolving technical issues for all functions to improve compliance throughout the Site.  Serve as investigation lead for process-impacting deviations and investigations.  Provide technical guidance on change controls and how they might impact the processes and product specifications. 
• Keep current with advances in technology as related to the Biosciences product lines.
• Plan and execute corrective actions to reduce process variability, improve product quality, or streamline production processes.  Own CAPAs from start to finish, including implementation.
• Organize, manage and improve Operations activities in support of the development of new products or processes and the manufacture of clinical and commercial products according to cGMPs and/or ISP regulations in a timely manner, right first time in accordance with department objectives.
• Communicate and coordinate clearly/extensively internally with other departments and all stakeholders to drive project completion.
• Supports manufacturing directly on isolations as needed to solve problems, improve processes by recognizing areas of opportunity through hands on experience, and support production goals. 

Education Requirements:

• Bachelors Degree in Related Science/Engineering Field
• Masters and PhD preferred

Experience Requirements:

• Intermediate to Advanced years of corporate experience in direct related work

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.