• Biotechnician II (Hopewell, NJ)

    BeOne Medicines (Pennington, NJ)


    General Description:

    The Biotechnician II position will directly enable the startup phase of the Hopewell manufacturing facility and then shift focus to hands-on execution and support of cGMP manufacturing operations.

     

    **Facility Start-Up** : Focused on related activities required to design, build, commission, and license BeOne’s first biopharmaceutical plant in the United States.

    **Essential Functions of the Job:** include but not limited to:

    + Design review

    + Equipment selection, procurement and testing

    + Protocol development and execution

    + Acceptance testing and equipment/automation debugging

    + Technical training

    **Hands-On cGMP Operations** : Focused on execution of cGMP manufacturing activities required to deliver the production plan reliably and compliantly.

    + 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

    **Leadership Skills** :

    + Support supervisor managing day to day activities, including staff availability and task load

    + Self-directed leadership within both predicable and ambiguous work environments

    + Thoughtfully escalates issues/concerns in a timely manner as appropriate

    Education / Experience Required:

    + High school education or GED and 1+ years’ experience in biopharmaceutical company required.

    + AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred.

    **Physical Requirements** :

    + Must be able to stand for long periods, up to 8 to 10 hours/day.

    + Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.

    + Must be able to work scheduled 40 hours with the ability to work overtime as needed.

    + Must be comfortable in working in varying temperatures.

    + Frequent lifting, pushing, pulling, and carrying. Ability to lift to 40 lbs.

    + Regular reaching, bending, stooping, and twisting.

    + Repetitive motion and substantial movement of the wrists, hands, and/or fingers.

    + Environment requires dedicated gowns, depending on area.

    + Work with hazardous materials and chemicals.

    + Willing to work any shift.

    **Computer Skills:** Familiarity with computer-based systems. Word, Excel, and PowerPoint a must.

    Other Qualifications:

    + 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.

    + Proactive identification and implementation of continuous improvement opportunities.

    + Aptitude for learning moderately complex technical systems.

    + Able to receive and incorporate feedback – passion for ongoing professional development a plus.

    **Travel:** International and domestic as required

     

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.