Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering.
5+ years of biotech industry experience (3+ years with Master’s, 2+ years with PhD) in process development and manufacturing.
Experience with large scale manufacturing support, preferably mammalian, and knowledge of current Good Manufacturing Practices.
Advanced knowledge of cell biology, cell culture, and bioreactor operation.
In-depth understanding of US/EU regulations related to manufacturing processes.
Willingness to provide 24/7 on-call support during manufacturing.
Responsibilities
Perform process transfer and support functions, including developing process understanding and conducting gap analysis.
Guide junior team members on process transfer and support activities.
Assess major deviations impacting product quality and identify root causes systematically.
Utilize problem-solving tools and conduct complex data analysis, including regression and multivariate analysis.
Author and review process documentation, including batch records and change controls.
Evaluate change controls for their impact on process performance and product quality.
Represent MSAT on project teams and during customer and regulatory audits.
Benefits
Competitive salary and comprehensive benefits package.
Opportunities for career development and advancement.
Supportive and collaborative team environment.
Access to cutting-edge technology and tools.
Commitment to employee well-being and safety.
Inclusive workplace culture.
Recognition and reward for your contributions.
Full Job Description
MSAT Process Engineer/Scientist III – Downstream
Location: On-site, Portsmouth, NH.
The MSAT Engineer/Scientist III is responsible for being the primary technical support for mammalian manufacturing processes. This person has in-depth experience with supporting manufacturing processes and/or technical transfer. The supervisor provides direction and oversight, as this level of Process Engineer/Scientist is expected to have a good grasp of the requirements of the role. The individual is a subject matter expert for key aspects of the role, and it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required.
What you will get:
Competitive salary and comprehensive benefits package.
Opportunities for career development and advancement.
Supportive and collaborative team environment.
Access to cutting-edge technology and tools.
Commitment to employee well-being and safety.
Inclusive workplace culture.
Recognition and reward for your contributions.
Access to our full list of global benefits: https://www.lonza.com/careers/benefits
What you will do:
Performs all functions associated with process transfer and process support, e.g. develop process understanding, perform gap analysis/FMEA, generate process models, author / review Process Descriptions and Batch Records, author/review planned deviations and change controls, perform process monitoring author campaign summary reports, perform activities for lot release.
May provide guidance on process transfer and support activities to junior members of the team.
Assess all major deviations including those that impact product quality and identify potential root causes using a systematic approach.
Experience using variety of problem solving tools e.g. Fishbone, Kepner-Tregoe etc. Able to identify potential solutions. Performs or is able to understand all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis.
Author and review process descriptions, definitive formulations, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates.
Assess change controls for impact of any change to the process, equipment or procedures that can affect process performance and product quality. Supports documentation preparation for regulatory purposes.
Represent MSAT on project teams and interfaces with customer technical and quality representatives. Represent MSAT on internal teams (e.g. Deviation and Run Daily Management System meetings). Participate in Customer and Regulatory Audits.
What we are looking for:
Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering.
5+ years of biotech industry experience (3+ years with Master’s, 2+ years with PhD) in process development and process scale up / manufacturing.
Experience with large scale manufacturing support (mammalian preferred), current Good Manufacturing Practices, US / EU regulations.
Advanced knowledge of cell biology, cell culture, scale up and mass transfer, bioreactor operation, disc stack centrifugation, filtration and intermediate knowledge of statistical data analysis.
In depth knowledge of large scale manufacturing, current Good Manufacturing Practices and US/EU regulations.
Willingness to provide 24/7 on-call support during manufacturing.
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.
