What are the responsibilities and job description for the Quality Control Biochemistry Analyst position at BeiGene?
BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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:
Perform QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, BeOne’s processes and procedures.
Essential Functions of the job:
- Perform QC biochemistry laboratory testing (e.g., DS, DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.
- Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, testing record keeping, etc.
- Manage inventory of reagents and supplies for the laboratory.
- Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
- Implement corrective actions and preventive actions (CAPAs).
- Participate in internal and external GMP audits, as needed.
- Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
- Train other junior level analysts and new hires.
- Subject matter expert in one or more areas of required testing.
- Undertake any other duties as required.
Core Competencies, Knowledge, and Skill Requirements
- 2 years’ experience with Bachelor’s in Chemistry, Biochemistry, or Biotechnology related scientific discipline.
- 2 years of working experience in an FDA-regulated biotechnology, pharmaceutical company are preferred.
- 5 years of experience preferred with no higher education.
- Working knowledge and experience with biochemistry analytical methods such as residual DNA by qPCR, host cell protein ELISA, Residual Protein A ELISA, binding activity ELISA, Capillary Electrophoresis (CE), capillary isoelectric focusing (cIEF), cell-based potency assay, etc.
- Working knowledge with USP/EP and cGMP/EU GMP regulations.
- Familiar with instrument and equipment validation.
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Strong leadership/team management skills and experience.
- Credible and confident communicator (written and verbal) at all levels.
- Strong analytical and problem-solving ability.
- Hands-on approach, with a ‘can do’ attitude.
- Ability to prioritize, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Committed to learning and development.
Significant Contacts
- Interacts with all levels of BeOne employees.
Computer Skills:
- Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Travel:
- Must be willing to travel approximately 10%.
- Ability to work on a computer for extended periods of time.
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
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 BeiGene, 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 and we value diversity. 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.
Salary : $77,500 - $107,500
