Analyst, QC Stability, US Site (Hopewell, NJ)

BeiGene 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:

Oversee the planning, execution, and documentation of QC stability studies under FDA/EU regulations, applicable International Regulations, BeiGene processes and procedures to support GMP manufacturing.

Essential Functions of the job:

• Develop, implement, and oversee QC stability testing protocols and schedules.
• Generate comprehensive stability reports with statistical analysis summaries.
• Apply statistical methods and tools to analyze stability data and trends.
• Perform routine operations, including instrument qualification and maintenance, SOP generation and revision, specifications generation and revision, sample management, record keeping, etc.
• Manage inventory of reagents and supplies for the laboratory.
• Conduct laboratory investigations, including OOS, Out-of-Trend, and deviations.
• Implement corrective actions and preventive actions (CAPAs).
• Participate in internal and external GMP audits, as needed.
• 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

• Bachelor's Degree or above in Chemistry, Biochemistry, Microbiology, or Biotechnology related scientific discipline.
• Minimum of 2 years of working experience in an FDA-regulated biotechnology, pharmaceutical company are required.
• 5+ years of experience preferred with no higher education.
• Proficiency in using LIMS software and related data analysis tools.
• Working knowledge of chemistry analytical methods such as HPLC, GC, subvisible particles, container closure integrity test (CCIT), and compendial methods.
• Working knowledge of biochemistry analytical methods such as qPCR, ELISA, cell-based potency assay, Capillary Electrophoresis (CE), etc.
• Working knowledge with USP/EP, ICH Guidelines and cGMP/EU GMP.
• 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 BeiGene employees.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• Ability to work on a computer for extended periods of time.

Travel:

• Must be willing to travel approximately 10%.

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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: $73,800.00 - $103,800.00 annually

BeiGene 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. BeiGene 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.