MSAT Process Engineer/Scientist III - Downstream

Lonza Group; Portsmouth, Northern (NH, KY); Hybrid; USD 110,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Career development

Collaborative team

Cutting-edge technology

Well-being & safety

Inclusive culture

Recognition rewards

Job summary

Lonza is seeking an MSAT Process Engineer/Scientist III – Downstream in Portsmouth, NH to provide primary technical support for mammalian manufacturing processes. The role involves process transfer, data analysis, and authoring critical manufacturing documents.

A strong background in GMP and process development is essential. You will join a collaborative MSAT team, contribute to regulatory documentation, and support 24/7 on-call manufacturing activities.

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 mammalian manufacturing support and GMP, US/EU regulations.

Responsibilities

• Perform process transfer and provide technical support for mammalian manufacturing processes.
• Develop process understanding, conduct gap analysis/FMEA, generate process models, and author/review process descriptions and batch records.
• Author/review planned deviations and change controls; perform process monitoring and campaign summary reports; support lot release.

Skills

Mammalian manufacturing

Process transfer

Data analysis

Root cause analysis

Batch records

Process validation

Education

Bachelor’s degree in Biotechnology/Biology/Chemical Engineering

Tools

Fishbone

Kepner-Tregoe

Job description

MSAT Process Engineer/Scientist III - Downstream

United States, Portsmouth (New Hampshire)

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.

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

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.

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.