Bachelor's, Master's, or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Chemistry, or related field.
Significant experience in Manufacturing Science and Technology (MSAT) and biopharmaceutical manufacturing.
Strong expertise in deviation investigations and root cause analysis.
Proven ability to lead technical projects in a GMP-regulated environment.
Experience with evaluating process changes and their impacts on quality.
Excellent technical writing and communication skills.
Knowledge of cGMP regulations and quality systems.
Responsibilities
Lead process transfer and support for commercial manufacturing processes.
Drive continuous improvement of MSAT practices and procedures.
Provide technical leadership to cross-functional teams for complex challenges.
Evaluate process changes and major deviations for manufacturing impact.
Conduct root cause investigations and implement corrective actions.
Assess new technologies for suitability in production environments.
Interface with customers and provide technical updates during meetings.
Benefits
Agile career and dynamic working culture.
Opportunities to lead high-impact technical initiatives.
Exposure to advanced biopharmaceutical manufacturing technologies.
Collaboration with global teams and industry experts.
Compensation programs recognizing high performance.
Medical, dental, and vision insurance.
Professional development and leadership growth opportunities.
Full Job Description
Senior Scientist, MSAT Process Transfer & Support Portsmouth, New Hampshire, USA
1st Shift Monday - Friday 8am - 5pm
In this role, you will provide technical leadership for process transfer, process support, and continuous improvement initiatives while partnering with manufacturing, quality, engineering, and customers to ensure robust and reliable commercial operations.
What you will get
An agile career and dynamic working culture.
Opportunities to lead high-impact technical and cross-functional initiatives.
Exposure to advanced biopharmaceutical manufacturing technologies.
Collaboration with global teams, customers, and industry experts.
Compensation programs that recognize high performance.
Medical, dental and vision insurance.
Professional development and leadership growth opportunities.
What you will do
Lead process transfer and process support activities for commercial manufacturing processes while driving continuous improvement of MSAT practices and procedures.
Provide technical leadership to cross-functional teams to address complex manufacturing, process performance, and product quality challenges.
Evaluate process changes, major deviations, and post-release issues for impact on manufacturing performance and product quality.
Conduct advanced root cause investigations using structured problem-solving tools and lead implementation of effective corrective and preventive actions.
Assess new technologies and manufacturing approaches for suitability and process fit within the production environment.
Interface directly with customers through IPT, JPT, JTT, and Joint Steering Committee meetings, providing technical updates and support while escalating significant business or operational risks when appropriate.
Author and review technical documentation, support change control assessments, participate in customer and regulatory audits, and represent MSAT across site and customer-facing initiatives.
What we are looking for
Bachelor's, Master's, or PhD degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Chemistry, or a related scientific discipline.
Significant experience in Manufacturing Science and Technology (MSAT), process transfer, technology transfer, process support, or biopharmaceutical manufacturing.
Strong expertise in deviation investigations, root cause analysis, data interpretation, and structured problem-solving methodologies.
Demonstrated ability to lead technical projects and influence cross-functional teams in a GMP-regulated environment.
Experience evaluating process changes, change controls, and manufacturing impacts on process performance and product quality.
Strong technical writing, communication, and customer-facing skills with the ability to effectively engage multiple stakeholders.
Working knowledge of cGMP regulations, quality systems, regulatory expectations, and commercial biologics manufacturing operations.
Ready to shape the future of life sciences? Apply now.
About Lonza America Inc
Lonza America Inc is a subsidiary of Lonza Group, a Swiss multinational company that provides products and services to the pharmaceutical, biotech, and specialty ingredients markets. Lonza America Inc is responsible for the North American market and offers a range of products and services, including custom manufacturing, research and development, and quality control testing. The company has a strong focus on sustainability and has implemented various initiatives to reduce its environmental impact. Lonza America Inc was founded in 1897 and has since grown to become a leading provider of products and services in the pharmaceutical and biotech industries.
