Biotechnician II

BeiGene•Hopewell, NJ

8d•Onsite

About The Position

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. The Biotechnician II position will work in a cleanroom environment and follow cGMP batch records and SOPs to manufacture drug products. Employees will support projects in conjunction with other GMP Manufacturing personnel (Leads, Supervisors, Managers). Employees will prepare suites for manufacturing operation and operate in a safe and compliant manner. The primary responsibility of the Biotechnician II will be to participate in the execution of all phases and facets of drug product formulation, filling, lyophilization, visual inspection, labeling, and packaging. This will include requesting materials, setup, preparation, final filtration, formulation, filling vials inside a Grade A isolator with an automated filling machine, lyophilization, labeling, visual inspection, packaging, and document review.

Requirements

Demonstrated ability to successfully gown into aseptic manufacturing areas
Excellent organization and time-management skills required
Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure
Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Self-Confidence & Ability to Accept & apply Lessons Learned as needed
Works with a sense of urgency, while engaging and listening to experts
Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills
Strong organizational skills with the proven ability to prioritize
Must be dependable and punctual
Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word
Must be flexible to work 1st or 2nd shift with holidays, weekends and overtime as per business needs
Bachelor’s degree or 1+ years of GMP Manufacturing experience required
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Responsibilities

Support all site validation protocol execution and report generation
Equipment start-up, troubleshoot, and perform acceptance testing
Support the team by training other team members
Execute on the floor operations during clinical and GMP campaigns
Procedural design (SOP’s, MBR’s, etc.) and approval
cGMP Manufacturing Equipment cleaning and sterilization
Solution preparation and transfer
Room and Equipment Cleaning
Equipment and process troubleshooting
Sterile Filtration / Integrity testing
Good Documentation Practices
Environmental Monitoring
Autoclaves and parts washers (equipment prep, cleaning and sterilization)
Familiar with and operate Vial washer, Tunnel, Filling, Lyophilizer, CIP skid, Inspection and Packaging DP equipment set up
Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace
Under the direction of the Production Supervisor, the Filling technician will work hands on, under ISO7, ISO8, ISO5 area and CNC with a variety of manufacturing production equipment and technologies