Senior Analyst, QC Biochemistry

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 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

• 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), 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

Supervisory Responsibilities:  

• N/A

Computer Skills:   

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

Other Qualifications:   Interacts with all levels of BeOne employees

Education Required:

• Bachelor’s Degree required in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 4+ years of working experience in an FDA-regulated biotechnology, pharmaceutical company are required.
• Master’s degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 2+ years of working experience in an FDA-regulated biotechnology, pharmaceutical company are preferred.

Travel:   

• Must be willing to travel approximately 10%.

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: $89,100.00 - $124,100.00 annually

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 r