Purification, Manufacturing Technician lI

General Description:

The Purification Manufacturing Technician l position will directly enable the initial start-up 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 cell culture related activities required to design, build, commission, and license BeiGene'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

Core Responsibilities/Experience:

• Focused on execution of cGMP manufacturing activities required to deliver the production plan reliably and compliantly.

• Essential functions of the job include but not limited to:

• Follow cGMP procedures to support manufacturing execution and automated recipes

• Clean-In-Place (CIP) & Steam-In-Place (SIP)

• Buffer preparation & transfers / filtration

• Operational and cleaning of chromatography and filtration systems.

• Equipment & process troubleshooting

• Deviation identification, reporting and closure

• cGMP procedure development and optimization

Core Competencies, Knowledge and Skill Requirements

• High school education or GED 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 12 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: Microsoft Office

Travel:

• Must be willing to travel approximately 10%.

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.