MSAT Senior Scientist

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The MSAT Senior Scientist is a critical individual contributor responsible for driving complex technical initiatives that support the Lonza site in Durham, NC. This role leads a variety of high-impact projects—including technology transfers, process validations, corrective and preventive action (CAPA) implementation, process optimization, and in-depth technical investigations. The Senior Scientist works cross-functionally to foster strong partnerships with Manufacturing, Quality, R&D, Tissue Acquisition, and Supply Chain teams. They serve as a subject matter expert (SME) in at least one key area: primary cell isolation, primary cell culture, technology transfer, or process optimization and validation.

Key Responsibilities:

• Accountable for project results, including planning and monitoring projects from initiation through completion using statistical tools to perform data mining, analyzing data, preparing reports, and generating presentations.

• Lead complex technical investigations and author technical protocols and reports often by leading multidisciplinary teams in a matrix structure to improve quality throughout the site.

• Perform process troubleshooting and optimization for manufacturing and quality.

• Finds opportunities for process improvement such as reducing process variability, streamlining manufacturing processes, growing efficiency, and evaluating and implementing new technologies.

• Responsible for tasks associated with tech transfers, process validation, process improvements, and quality/deviation/customer inquiry investigations.

• Manages operational excellence tasks to ensure site metrics are achieved.

• Manages Change Controls, Deviations/CAPAs following Lonza’s SOPs and Quality Systems tools.

• Establishes credibility and positive relationships with the key stakeholders and functional groups.

• Trains manufacturing technicians and quality analysts as needed.

• Follows all training and policy guidelines established for the facility.

• Perform other duties as assigned.

Quality Responsibility:

• Maintenance of quality systems for the business by ensuring all team members align with processes, procedures, and instructions for all activities in which the team participates.

Safety Responsibility:

• Is knowledgeable and aligns with all pertinent safety policies, rules, and regulations.  Ensures that all team members align with safety rules and regulations.

Key Requirements:

• 7+ years’ experience with animal/human primary cell isolations and/or cell culture experience.

• Proficient in various cell biology techniques including flow cytometry, ICC, PCR, etc.

• Proficient in using data analysis tools such as JMP, Minitab or Statistica.

• Experience in Tech Transfers and aseptic processing.

• Compliance minded with excellent technical writing skills.

• Excellent communication skills, able to professionally converse about highly technical concepts.

• Proven ability to perform root cause analysis, FMEA, and develop corrective and preventive actions to reduce likelihood of recurrence.

• Able to independently monitor, analyze, and report on problem record trends for the functional areas to reduce non-conformances.

• Able to translate opportunities into workable solutions.

• Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment

• Demonstrates strong business awareness.

• Leadership: ability to lead and influence team and collaborators

• Hands-on demeanor to get things done and ability to take calculated risks.

• Strong customer focus: dedicated to providing high-quality products and services that meet all expectations with solid follow-up skills and high attention to detail.

• Must possess excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.

Working Conditions:

• This role involves office work as well as work in manufacturing and laboratory settings. When working in manufacturing and laboratory sett