![The Fountain Group](https://media.trabajo.org/img/noimg.jpg)
Bioprocess Specialist
2 months ago
Job Description:
**ONSITE: Monday-Friday 8am-5pm**
- The MS&T Specialist provides technical support to Princeton, NJ Facility. Manufacturing processes in a GMP environment.
- Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process.
- The MS&T Specialist works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions.
- Other responsibilities include participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site.
- The MS&T Specialist works to identify and drive continuous improvements to the manufacturing process.
- Responsibilities:
- Functions as a technology and process subject matter expert.
- Provides on-the-floor and on-site technical support to manufacturing when necessary.
- Author, review and approve, as needed, various documents (eg. Batch records, SOPs).
- Author, and approve protocol and reports in accordance with internal and external regulatory expectations (Client, Engineering, Tech Transfer).
- Analyze and summarize manufacturing data to support impact assessments and investigations.
- Owner of change controls for process and procedure changes.
- Lead and executes CAPA system investigations.
- Leads technology transfer efforts for new processes and product implementation.
- Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs.
- Applies continuous improvement tools to identify and close procedural and compliance gaps
- Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.
- Represent MSAT and interface with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
- Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirement specifications, and participating on impact assessments.
- Ability to perform gowning activities and enter the manufacturing plant.
- Some travel will be required.
- Required:
- BS, MS, or PhD (advanced degree preferred)
- 5+ years pharma
- 3+ years cell therapy biologic manufacturing process/tech support
- Scientific understanding in bioprocessing principles
- Experience in Process qualification, validation
- Experience working with external parties and/or cross-functional teams
- Experience interfacing with clients
- Preferred:
- Familiarity with cGMP
- Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
- Experience with program management software and tools
Compensation: Up to $60 per hour depending on experience
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