Manager, Quality Control Chemistry

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 with a primary focus on capillary electrophoresis techniques to support GMP manufacturing testing and release of material intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations applicable International Regulations and BeOne Medicines processes and procedures.

Essential Functions of the job:

• Perform routine and non-routine testing using capillary electrophoresis techniques (e.g. CE-SDS CZE icIEF) in the QC biochemistry laboratory to ensure timely and compliant generation and reporting of in-process release and stability test results in support of manufacturing operations.

• Review interpret and report analytical data in accordance with GMP regulations and internal procedures.

• Lead troubleshooting efforts for analytical methods and instrumentation related to CE.

• Conduct laboratory investigations including OOS Out of Trend deviations and invalid assays.

• Implement corrective actions and preventive actions (CAPAs).

• Participate in transfer and method validation activities including protocol preparation protocol execution and report preparation.

• Support routine operations including but not limited to instrument qualification and maintenance SOP generation and revision test record keeping etc.

• Maintain equipment in a qualified and calibrated state coordinating with metrology or vendors as needed.

• Manage inventory of reagents and supplies for the laboratory.

• Participate in internal and external GMP audits as needed.

• Train analysts and new hires on CE instrumentation GMP practices and data analysis.

• Serving as subject matter expert in one or more areas of required testing.

• Undertake 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.

• Familiar with Waters Empower Chromatography Data System.

• 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.

Supervisory Responsibilities:

• Manage 2 QC Analysts

• Experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources

Education/Experience Required:

• Bachelors Degree in Chemistry Biochemistry or Biotechnology related scientific discipline with 5 years of GMP testing using capillary electrophoresis techniques in an FDA-regulated biotechnology pharmaceutical company is required.

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 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 .