Biotechnician I
BeiGene
Summary
The Biotechnician I position will directly support the startup phase of the Hopewell manufacturing facility and then shift focus to hands-on execution and support of cGMP manufacturing operations.
Job description
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
- Design review
- Equipment selection, procurement and testing
- Protocol development and execution
- Acceptance testing and equipment/automation debugging
- Technical training
Hands-On cGMP Operations
- 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 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
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
Education Required
- High school education or GED required
- AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred
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
Requirements
- High school education or GED required
- AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred
- Familiarity with computer-based systems; Word, Excel, and PowerPoint a must
- Must be able to stand for long periods, up to 8 to 10 hours/day
- Ability to lift up to 40 lbs
- Willing to work any shift
- 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
- Aptitude for learning moderately complex technical systems
Benefits
- Medical, Dental & Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Annual bonus plan
- Discretionary equity awards
- Employee Stock Purchase Plan
Company overview
BeiGene, Ltd., now rebranding as BeOne Medicines, is a global commercial-stage biotechnology company specializing in the discovery, development, manufacturing, and commercialization of innovative oncology medicines. Founded in 2010 by John V. Oyler and Xiaodong Wang, the company has grown into a multinational organization with headquarters in Cambridge, Massachusetts, Beijing, China, and Basel, Switzerland. BeiGene focuses on developing targeted and immune-oncology therapies for cancer treatment, with a diverse pipeline that includes internally discovered products like BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor, and Tevimbra (tislelizumab), a PD-1 inhibitor. The company operates across six continents with over 45 countries participating in clinical trials and has enrolled more than 30,000 patients in its research programs. With approximately 12,000 employees worldwide, BeiGene has established itself as a significant player in global oncology, particularly with strong market presence in China and expanding operations in the United States and Europe. The company's mission centers on expanding access to high-quality cancer therapies worldwide through persistent innovation and challenging traditional approaches to drug development.