Biotechnician III

beigene; Hopewell (VA); On-site; USD 42,000 - 64,000; Full time

Job summary

BeOne in Hopewell, VA is seeking a Biotechnician III to help launch its first US biopharmaceutical plant, then transition to hands-on manufacturing support.

Responsibilities include cGMP operations, media prep, cell culture sampling, purification operations, documentation, and equipment maintenance, with potential for leadership in supervisor absence.

Qualifications

• 3+ years of experience in a biopharmaceutical setting.
• AS/BS/BA in science related field preferred.
• Strong technical aptitude and ability to work in a fast-paced environment.
• Experience with cGMP and regulatory compliance.

Responsibilities

• Perform hands-on cGMP manufacturing activities to deliver production plan.
• Follow cGMP procedures for manufacturing execution.
• Media preparation and transfers / filtration (cell culture group if applicable).
• Cell culture sampling, monitoring and transferring (cell culture group).
• Validation and operation of CIP/SIP equipment and other processing systems.
• Complete batch documentation and review records for accuracy.

Skills

cGMP Operations

Troubleshooting

DCS operation

Cell culture

Quality documentation

Communication skills

Education

AS/BS/BA in science related field

High school + 3+ years biopharmaceutical experience

Tools

Word

Excel

PowerPoint

Job description

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, 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 (

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity