
Manufacturing Sciences Engineer II
- Lexington, MA
- $70,000-110,000 per year
- Permanent
- Full-time
- Assist in design and execution of continuous process improvements, aimed at improving robustness, capacity, and productivity.
- Provide technical expertise in identifying opportunities/areas, planning, designing and conducting experiments, analyzing data and documenting results towards continuous process improvement, including reducing recurring deviations, and increasing level of safety and/or compliance.
- Provide high quality of written study proposals, research and development reports, and investigation reports.
- Provide technical expertise in troubleshooting and root cause analysis for process discrepancies and quality investigations of a complex technical nature
- Independently design and execute cell culture experiments related to characterization of cell culture parameters
- Apply engineering principles in scaling up from bench to pilot plant or GMP manufacturing scale.
- Manage and maintain data in an organized manner. This includes keeping proper GLP lab documentation, authoring technical reports, tech transfer documents and preparing scientific presentations as needed.
- Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively.
- Be customer focused, results oriented, science driven and embrace Takeda's values.
- Have the attitude to proactively learn new technologies and manage changes in cell culture process development and improvement.
- Execute cell culture or clarification process improvement, troubleshooting and manufacturing technical support.
- Assist in analyzing complex technical problems, then finding and implementing solutions.
- Apply fundamental scientific and biological principles to practical technical challenges.
- Under supervision, plan and execute experimental studies.
- Work with his/her supervisor and coworkers in managing multiple work streams and projects.
- Provide input to departmental management towards making functional decisions.
- BS in Biochemistry or Chemical Engineering or related disciplines
- 1 year work experience in the biotechnology industry.
- Ability to work in a fast-paced environment with demonstrated capacity to juggle multiple tasks and demands.
- Hands-on experience in cell culture or depth filtration, ultra-filtration in lab or manufacturing scale would be ideal.
- Knowledge of GMP working environments would be ideal.
- Have basic knowledge of mammalian cell culture
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.