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?:
Backg
$53hr
12 MONTHS
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.