Manufacturing Technician I, Production Support
About this role
Description
Under supervision, the Manufacturing Technician, Production Support, will perform routine manufacturing activities in GMP manufacturing areas, solution preparation, dispensing raw material, bioprocessing support and autoclave operation. Operations will be performed according to Standard Operating Procedures (SOP), Work Instructions (WI) and Master Batch Records (MBR). Perform manufacturing steps, execute routine MBRs, and revise documents such as MBRs and SOPs as needed. Flexible shift schedules and overtime may be required.
Job Responsibilities:
- Perform GMP manufacturing activities in assigned areas.
- Perform routine cleaning activities in GMP manufacturing areas
- Follow Standard Operating Procedures (SOPs), cGMPs, plant safety guidelines and other established procedures during the manufacturing process to produce quality products.
- Set-up, operate, maintain and clean bioprocessing equipment.
- Demonstrate good aseptic technique.
- Perform dispensing raw material.
- 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.
- Draft and revise SOPs and batch records.
- Address production issues and report any compliance related concerns to the supervisor.
Requirements
Education and Experience:
- High School Diploma, Bachelor's or advanced degree in life sciences or related discipline, or equivalent education and experience.
- High school diploma with 3 or more years of experience in the pharmaceutical or biotech industry
- Bachelor's degree with 0-3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
Knowledge, Skills and Abilities:
- cGMP manufacturing for biological products is preferred.
- Fundamental 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.
- Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.
Company at a glance
Bora Biologics: Accelerating Success in Biologics Development
With a proven track record of over 100 successful cGMP manufacturing batches and the development of more than 42 biologics and biosimilars, Bora Biologics exemplifies how experience drives success. We offer agile, comprehensive end-to-end CDMO solutions that optimize time and cost efficiencies for biopharma companies around the world.
Leveraging our global CDMO capabilities, our state-of-the-art, FDA-registered facility in the U.S., and our deep expertise in biologics development and manufacturing, we provide efficient and effective pathways to market for clients.
We specialize in a diverse range of biologics, including monoclonal antibodies (mAbs), bi-specifics, fusion proteins, recombinant proteins, and enzymes. From cell line development to commercial manufacturing, our team brings extensive global and regional regulatory affairs expertise to ensure compliance and success at every stage of the process.
- Mammalian and Microbial GMP Manufacturing
- Early, Late-Stage and Commercial Production
- Integrated Process and Analytical Development
- Formulation and Drug Product Development
- Quality Control and Assurance
State-of-the-Art Facilities & Highlights
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Bora Biologics | San Diego, California, USA
+FDA Registered
+130,000 sf GMP and R&D space
+14,000 sf temperature controlled GMP warehouse
+Single-Use Bioreactors (SUBs): 2 x 50L, 2 x 250L, 4 x 1000L , 2 x 2000L (in plan)
+Stainless Steel Fermentors: 1 x 150L, 1 x 300L (SUF)
+3 GMP suites
Bora Biologics | Zhubei City, Taiwan
+70+ cGMP batches with 100% success rate continuously since 2014
+48,000 sf of GMP and R&D space
+cGMP, ICH, FDA, EMA, TFDA, PIC/S
+Single-Use Bioreactors (SUBs): 2 x 50L, 4 x 500L (2 in plan)
Partner with us today to discover how our EXPERIENCE can accelerate your success.
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