Biotechnician III

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, 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 (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.

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

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 may be required (< 5%).

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.