BeiGene

Drug Product Manufacturing Technician II, Fill/Finish Operation

Hopewell Full time

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, 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, labeling, visual inspection, packaging, document review.

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 washers (equipment prep, cleaning and sterilization)

    • Familiar with Vial washer, Tunnel, Filling, 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

Education/Experience Required:

  • Bachelor’s degree or 1+ years of GMP Manufacturing experience required

  • 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

  • Customer/Client Focus

Computer Skills:

  • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel:  International and domestic – periodically

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

Salary Range: $27.45 - $36.45 per hour

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.