MSAT Upstream Scientist/Process Engineer (Midlevel and Senior)

Lonza - Portsmouth, NH

Full-time - Mid Level

Portsmouth, NH

Professional, Scientific, and Technical Services

About the position

Lonza in Portsmouth, NH is seeking a driven Upstream Manufacturing Science and Technology (MSAT) Scientist or Process Engineer to join our team. In this role, you will primarily serve as a Subject Matter Expert (SME) for upstream manufacturing processes. The ideal candidate should possess experience in supporting at-scale upstream processing. This position presents a fantastic opportunity for individuals with varying levels of experience to enter a MSAT role, focusing on upstream aseptic techniques and mammalian cell culture. As a key member of our team, you will represent Manufacturing Science and Technology (MSAT) on project teams, interfacing with customer technical and quality representatives. You will develop a deep understanding of processes and author, review, and own process-related documentation, including process descriptions and batch records. Additionally, you will be responsible for authoring and reviewing change controls, managing the implementation of changes as the assigned change agent. Monitoring and reporting on process performance through manufacturing data analysis and delivering data in the form of live presentations will also be part of your responsibilities. This is an individual contributor position and will not have direct reports.

Responsibilities

• Represents Manufacturing Science and Technology (MSAT) on project teams as a technical subject matter expert (SME) and interfaces with customer technical and quality representatives.
• Develops process understanding and expertise.
• Authors, reviews, and owns process-related documentation, such as process descriptions and batch records.
• Authors/reviews change controls, including managing the implementation of the change as the assigned change agent.
• Monitors and reports on process performance through manufacturing data analysis and delivers data in the form of live presentations.

Requirements

• Minimum of Bachelor of Science degree required, preferably in Biotechnology, Biological Sciences, or Chemical Engineering.
• A range of experience with biotech, process development, process scale-up, tech transfer, and/or manufacturing.
• Experience with cell biology, cell culture, scale-up and mass transfer, bioreactor operation, disc stack centrifugation, and statistical data analysis.
• Strong knowledge of aseptic technique and mammalian cell culture.
• Experience with large scale 2 kL bioreactors preferred, with mammalian manufacturing support preferred, and ability to follow cGMP and US/EU regulations.
• Strong communication skills, able to clearly express ideas and points of view both verbally and in writing, with good interpersonal skills.
• Shows commitment and dedication, striving to be ahead of schedule.
• Practices safety awareness at all times and considers the impact of actions prior to executing activities.
• Ability to share 24/7 on-call support while the process is being manufactured.