BioSpace
Sr. Technician / Specialist, Bioprocess - Upstream processing
BioSpace, Pennington, New Jersey, us, 08534
Sr. Technician / Specialist, Bioprocess - Upstream Processing
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group founded in 2002 with a presence in North America, Europe, Greater China, and Asia Pacific. Its businesses include a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. GenScript is committed to being the most reliable biotech company to improve human and natural health through biotechnology.
Job Scope The Technician/Specialist, Bioprocess – Upstream Processing will work within the Upstream Processing group and perform the following activities while executing upstream operations:
Preparation of stock solutions, buffers and media.
Filtration of stock solutions, buffers and media.
Set‑up and operation of disposable fermenters / bioreactors and other disposable bioprocess equipment including depth filtration.
Passage and expansion of microbial and mammalian cell lines.
Support relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Execute routine complex manufacturing assignments; recognize deviations from procedures and raise issues for resolution.
Adhere to cGMP and SOPs.
Perform routine microbial and mammalian cell culture using aseptic techniques; monitor fermenters and bioreactors.
Weigh and check raw materials, assemble process equipment, and monitor processes.
Complete work instructions and maintain clean‑room environment to comply with regulatory requirements; remove red bag waste as required.
Operate all production equipment in the assigned functional area per written procedures.
Author solution preparation Master Batch Records (MBRs) by transferring technical information from scientific and development documents.
Propose and route revisions to existing SOPs for the functional area equipment.
Participate in low‑risk deviation investigations; assist with CAPA action items within agreed timelines.
Conduct safety and GMP self‑auditing walkthroughs; document observations and track.
Log and submit samples in LIMS; track results and compile data.
Review own work for completeness on executed MBRs.
Coordinate return of executed records to Quality department for review.
Coordinate with Logistics to ensure needed materials are delivered timely; monitor material supply to alert Logistics of shortfalls.
Perform other tasks and assignments as needed and specified by management.
Qualifications
Bachelor’s degree in science or engineering with 0–5 years of relevant experience, or Associate’s degree with minimum 3 years, or High school diploma with minimum 7 years.
Demonstrated ability to follow written instructions and procedures.
Demonstrated strict attention to detail.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work collaboratively in a fast‑paced, matrixed team environment with internal and external stakeholders.
GenScript USA Inc./ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. The Company’s policy is to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc./ProBio Inc. maintains a drug‑free workplace.
Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/ProBio does not request personal information from candidates through individual email or any other platform.
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Job Scope The Technician/Specialist, Bioprocess – Upstream Processing will work within the Upstream Processing group and perform the following activities while executing upstream operations:
Preparation of stock solutions, buffers and media.
Filtration of stock solutions, buffers and media.
Set‑up and operation of disposable fermenters / bioreactors and other disposable bioprocess equipment including depth filtration.
Passage and expansion of microbial and mammalian cell lines.
Support relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Execute routine complex manufacturing assignments; recognize deviations from procedures and raise issues for resolution.
Adhere to cGMP and SOPs.
Perform routine microbial and mammalian cell culture using aseptic techniques; monitor fermenters and bioreactors.
Weigh and check raw materials, assemble process equipment, and monitor processes.
Complete work instructions and maintain clean‑room environment to comply with regulatory requirements; remove red bag waste as required.
Operate all production equipment in the assigned functional area per written procedures.
Author solution preparation Master Batch Records (MBRs) by transferring technical information from scientific and development documents.
Propose and route revisions to existing SOPs for the functional area equipment.
Participate in low‑risk deviation investigations; assist with CAPA action items within agreed timelines.
Conduct safety and GMP self‑auditing walkthroughs; document observations and track.
Log and submit samples in LIMS; track results and compile data.
Review own work for completeness on executed MBRs.
Coordinate return of executed records to Quality department for review.
Coordinate with Logistics to ensure needed materials are delivered timely; monitor material supply to alert Logistics of shortfalls.
Perform other tasks and assignments as needed and specified by management.
Qualifications
Bachelor’s degree in science or engineering with 0–5 years of relevant experience, or Associate’s degree with minimum 3 years, or High school diploma with minimum 7 years.
Demonstrated ability to follow written instructions and procedures.
Demonstrated strict attention to detail.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work collaboratively in a fast‑paced, matrixed team environment with internal and external stakeholders.
GenScript USA Inc./ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. The Company’s policy is to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc./ProBio Inc. maintains a drug‑free workplace.
Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/ProBio does not request personal information from candidates through individual email or any other platform.
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