Biotechnician III

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The Biotechnician III position will directly phase 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:

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 (if working in cell culture group)
Cell culture sampling, monitoring & transferring (if working in cell culture group)
Harvest operations (if working in cell culture group)
Operational and cleaning of chromatography and filtration system (if working in purification group)
Buffer preparation & transfers / filtration

Equipment & process troubleshooting

Deviation identification, reporting, drafting, investigate closure

Change control drafting, presenting, closurecGMP 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 (if working in Drug Product group)
Performing in-process visual inspection for quality assurance (if working in Drug Product group)
Labeling and packaging of finished drug product in compliance with cGMP (if working in Drug Product group)
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 (DCS)
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.

Cleaning of equipment and facility.

Collection of samples for environmental monitoring

Removal of process waste

Leadership

Skills:

Perform as acting supervisor/leader in the absence of supervisor.

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

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.

Education Required:

High school education or GED and 3+ years’ experience in biopharmaceutical company required.

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