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Full-timeDescription
SUMMARY
Under supervision, the Manufacturing Associate II, will perform routine manufacturing activities in GMP manufacturing areas including solution preparation, fermentation and/or cell culture and the associated sub-processes/preparation. Operations will be performed according to Standard Operating Procedures (SOPs) and batch records. Perform manufacturing steps, execute routine batch records, and revise documents such as batch records and SOPs as needed. Flexible shift schedules and overtime may be required.
JOB RESPONSIBILITIES
Essential
- Initiate Quality Events – IRs, DEVs, and OOTs.
- Set-up, operate, maintain and clean bioprocessing equipment.
- Demonstrate good aseptic technique.
- Basic troubleshooting of bioprocess equipment.
- Perform manual cleaning and sterilization of parts and components.
- Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the good manufacturing documentation practices.
- Address production issues and report any compliance related concerns to supervisor.
Supplementary Responsibilities
- May initiate Change Controls and Master Control DCRs
- May draft and revise SOPs and batch records.
- Perform GMP manufacturing activities in assigned areas.
- Follow Standard Operating Procedures (SOPs), cGMPs, plant safety guidelines and other established procedures during the manufacturing process to produce quality products.
JOB REQUIREMENTS
Education and Experience Required
- High School Diploma/GED greater or equal to 6 years of professional relevant experience or BS degree greater or equal to 3 years of professional relevant experience in the pharmaceutical or biotech industry.
Knowledge, skills and abilities
- cGMP manufacturing for biological product preferred.
- Upstream experience in cell passaging, aseptic technique, working with bioreactors, fermentors, and harvest filtration systems.
- Media and Buffer solution preparation experience
- Basic knowledge of current biologics regulations and cGMP for drug substance operation.
- Proficient with Microsoft Word and Excel.
- Able to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.
- Demonstrated ability to follow and document activities in written procedures and/or logbooks.
- Detail oriented, strong team player.
- Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.
Salary Description67,150 - 80,000
