Biotechnician I (Hopewell, NJ)

BeiGene•Hopewell, VA

1d•Onsite

About The Position

The Biotechnician I position will directly support the startup phase of the Hopewell manufacturing facility and then shift focus to hands-on execution and support of cGMP manufacturing operations. The role involves supporting the design, build, commissioning, and licensing of BeOne’s first biopharmaceutical plant in the United States, followed by hands-on execution of cGMP manufacturing activities to ensure reliable and compliant production. This includes media preparation, cell culture operations, harvest, buffer preparation, chromatography, filtration, troubleshooting, deviation management, change control, procedure development, material verification, formulation, aseptic filling, visual inspection, labeling, packaging, batch documentation, cleanroom operations, and environmental monitoring.

Requirements

High school education or GED required.
Evidence of good verbal and written communication.
Ability to work in fast paced dynamic environment with competing priorities.
Demonstrated ability to collaborate within and between diverse groups.
Aptitude for learning moderately complex technical systems.
Able to receive and incorporate feedback
Familiarity with computer-based systems.
Word, Excel, and PowerPoint a must.

Nice To Haves

AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred.
passion for ongoing professional development a plus.

Responsibilities

Design review
Equipment selection, procurement and testing
Protocol development and execution
Acceptance testing and equipment/automation debugging
Technical training
Follow cGMP procedures to support manufacturing execution and automated recipes
Media preparation & transfers / filtration
Cell culture sampling, monitoring & transferring
Harvest operations
Buffer preparation & transfers / filtration
Operational and cleaning of chromatography and filtration systems
Equipment & process troubleshooting
Deviation identification, reporting, drafting, investigate closure
Change control drafting, presenting, closure
cGMP procedure development and optimization
Requesting, staging, and verifying materials for production activities
Setup and preparation of equipment for formulation and filling
Final filtration and formulation of drug product
Aseptic filling of vials inside a Grade A isolator using automated filling equipment
Performing in-process visual inspection for quality assurance
Labeling and packaging of finished drug product in compliance with cGMP
Completing batch documentation and reviewing records for accuracy
Supporting routine cleanroom operations, equipment sanitization, and environmental monitoring
Assisting in deviation investigations and participating in CAPA implementation as needed
Operation of Distributed Computer System (DSC)
Operation of equipment’s such as Clean-in-Place (CIP), Steam-in-Place (SIP) skid, Caustic skid, autoclave, part washer, filter integrity tester, biowelders, etc.
Operation of SoloVPE protein concentration analyzer
Cleaning of the facility
Collection of samples for environmental monitoring
Removal of process waste
Support supervisor managing day to day activities, including staff availability and task load
Self-directed leadership within both predictable and ambiguous work environments
Thoughtfully escalates issues/concerns in a timely manner as appropriate