Title: Manufacturing Process Specialist
Location: Greater Boston
Summary: A Biotechnology Research company is currently seeking a driven, and motivated Process Specialist to join their Technical Operations team in the Greater Boston Area. You will play a key role in supporting GMP manufacturing, continuous improvement projects, and more. In addition to that, you will be able to make a direct impact on the company by being the SME for drug product manufacturing processes.
The Manufacturing Process Specialist will have these Key Responsibilities:
- Work cross-functionally and represent the TechOps team as the subject matter expert (SME) and provide assessment for process changes and transfers in a cGMP Manufacturing environment
- Write and review inspections technical documentation and process validation for drug product manufacturing processes
- Troubleshoot deviations and complex problems by performing data analysis and technical reports, and propose data-based improvements and solutions while working in a cross functional team
- Perform technology evaluations and support implementation of projects at site level
The Manufacturing Process Specialist will have the following qualifications:
- Bachelor's Degree; Strong knowledge of pharmaceutical manufacturing, specifically with cell culture and aseptic processing
- Must have knowledge of statistical process controls and data management tools, as well as validation, lifecycle management, and process development
- Ability to work in a cross functional team and lead investigations/deviations, as well as other technical documentation experience
This company offers a competitive and flexible benefit plan, along with a focus on your well-being, which will allow you to have a healthy work-life balance.
- Generous paid time off, wellness offerings, and more
- Career development opportunities, internal growth