MSAT Process Engineer/Scientist III (Downstream)

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Competitive salary and benefits

Career development and advancement

Collaborative team environment

Access to cutting-edge technology and

Employee well-being and safety

Inclusive workplace culture

Recognition and rewards

Job summary

Lonza in Portsmouth, NH, is seeking an MSAT Process Engineer/Scientist III – Downstream to provide expert technical support for mammalian manufacturing processes and tech transfer.

You will lead process transfer activities, develop process understanding, and author critical documentation while solving complex data analyses. This role demands on-call readiness and cross-functional collaboration with customer and regulatory teams.

Qualifications

• Bachelor's degree in Biotechnology, Biological Sciences, or Chemical Engineering.
• 5+ years of biotech industry experience in process development and scale-up/manufacturing.
• Experience with large-scale mammalian manufacturing support and GMP/compliance.
• Advanced knowledge of cell biology, culture, scale-up, mass transfer and bioreactor operation.
• In-depth knowledge of large-scale manufacturing, GMP, and US/EU regulations.
• Willingness to provide 24/7 on-call support during manufacturing.

Responsibilities

• Provide primary technical support for mammalian manufacturing processes and tech transfer.
• Lead process transfer activities: gap analysis/FMEA, process models, and batch records.
• Author/review process descriptions, planned deviations, and change controls.
• Conduct data analyses (ANOVA, regression, multivariate) to troubleshoot and optimize processes.
• Represent MSAT on project teams and participate in audits and regulatory interactions.
• Guide junior team members on transfer and support activities.

Skills

Process development

Data analysis

Regulatory knowledge

Problem solving

Education

Bachelor's degree in Biotechnology/Biological Sciences/Chemical Engineering

Tools

Fishbone analysis

Kepner-Tregoe

Statistical analysis

Job description

MSAT Process Engineer/Scientist III – Downstream

United States, Portsmouth (New Hampshire)

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.

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.

Qualifications

• 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.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.