Tech Transfer Scientist/Engineer.

This position is responsible for taking an active role in the
technical transfer of processes into the clinical manufacturing facility
and/or transfer of processes out to commercial manufacturing or a CMO.
Some of the detailed responsibilities will include:
- Lead meetings to facilitate the Tech Transfer process.
- Identify, communicate, track, and hold team members accountable for project deliverables.
- Evaluate lab-scale processes and define the scaled up process for the clinical production facility.
- Interface with development scientists and propose options to resolve process fitting issues.
- Capture and convey process details by preparing detailed Process Flow Diagrams
- Provide raw material forecasts for clinical campaigns.
- Write master batch records and solution records for clinical production.
- Monitor the progression of the clinical campaigns and provide data summaries to stakeholders
- Write campaign summaries and provide information for regulatory filings
- Participate in and/or initiate continuous improvement projects.
- Provide support for engineering studi

Qualifications
Background in a biological or engineering discipline (Biotechnology, Biochemistry, Biochemical Engineering, or equivalent).
Experience with project management tools and methodologies is desirable.

What is the minimum education experience required?:

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$53hr

12 MONTHS