Lonza
MSAT Process Engineer/Scientist III (Downstream)
US - Portsmouth, NH · Mid
Sponsorship not specifiedDetected 13 days ago
Data AnalysisCustomer SupportCell CultureCollaborationProblem Solving
About the role
- MSAT Process Engineer/Scientist III - Downstream Location: On-site, Portsmouth, NH.
- Represent MSAT on internal teams (e.g. Deviation and Run Daily Management System meetings).
- Participate in Customer and Regulatory Audits.
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.
- Performs or is able to understand all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis.
- 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.
- Willingness to provide 24/7 on-call support during manufacturing.
Requirements
- This person has in-depth experience with supporting manufacturing processes and/or technical transfer.
- 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.
- 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.
- 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.
Nice to have
- Experience with large scale manufacturing support (mammalian preferred), current Good Manufacturing Practices, US / EU regulations.
Skills
- Competitive salary and comprehensive benefits package.
- Opportunities for career development and advancement.
- Access to cutting-edge technology and tools.
- Commitment to employee well-being and safety.
- Inclusive workplace culture.
- Recognition and reward for your contributions.
Compensation
- Competitive salary and comprehensive benefits package.
Benefits
- https://www.lonza.com/careers/benefits
Company info
- What we are looking for:
- 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.
This listing is sourced directly from Lonza's careers page and normalized into a canonical job model.