MSAT Process Engineer/Scientist II (Downstream)

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

Benefits offered by this job

Competitive salary & benefits

Career development opportunities

On-site work in Portsmouth, NH

Job summary

Lonza Portsmouth, NH is seeking an MSAT Process Engineer/Scientist II (Downstream) to provide primary technical support for mammalian manufacturing processes. The role emphasizes process transfer, batch records, and regulatory-ready documentation, with on-call support and cross-functional collaboration.

You will develop process understanding, perform gap analyses and prepare change controls, while guiding junior team members and interfacing with customers and regulatory bodies.

Qualifications

• Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering.
• 3+ years of biotech industry experience 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.

Responsibilities

• 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.

Skills

Process development

Scale-up

Mammalian manufacturing

Statistical analysis

Process transfer

Education

Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering

Job description

MSAT Process Engineer/Scientist II (Downstream)

United States, Portsmouth (New Hampshire)

MSAT Process Engineer/Scientist II – Downstream

Location: On-site, Portsmouth, NH.

The MSAT Process Engineer/Scientist II 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.

What we are looking for:

Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering.

3+ years of biotech industry experience (2+ years with Master’s) 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

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

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.