MSAT Process Engineer/Scientist III (Downstream)

About the role

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, and it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required.

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.

Requirements

• 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.

Qualifications

• None specified

Skills

• Problem-solving skills
• Data analysis skills
• Writing and reviewing technical documents
• Understanding of large-scale manufacturing processes
• Knowledge of US/EU regulations
• Ability to provide on-call support

Benefits

• Competitive salary
• Comprehensive benefits package
• Career development and advancement opportunities
• 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 contributions

Pay

• Not specified

Schedule

• Not specified