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

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 Chemistry laboratory activities to support GMP manufacturing testing and release of materials intermediates and finished products under FDA/EU regulations applicable International Regulations BeOne processes and procedures. Establishes and implements QC Chemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Chemistry laboratory. This position reports to the QC Manager and is located full time at the Hopewell NJ site.

Essential Functions of the Job:

• Perform routine and non-routine testing using HPLC UPLC UV-Vis capillary electrophoresis and other techniques (PS-20 HPLC-SEC TOC Conductivity CZE etc.) in the QC Chemistry and Raw Materials 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.

• Ensure appropriate investigation of OOS events discrepancies lab errors and equipment failures.

• 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 other junior level analysts and new hires on instrumentation GMP practices and data analysis.

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

Undertake other duties as required.

• Ensure timely completion of testing (e.g. In-process control DS release DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.

• Review of laboratory test results ensuring adherence to Good Documentation Practices.

• Expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment ensuring compliance with industry standards and regulations through hands-on laboratory experience.

• Working knowledge and experience with analytical methods such as GC HPLC UPLC IEF TOC UV FTIR etc.

• Knowledgeable with USP/EP and cGMP/EU GMP regulations.

• Familiar with instrument and equipment validation.

• Expert knowledge of quality control principles practices and standards for the biopharmaceutical industry.

• Impressive demonstrable track record and skills/experience gained within a similar position(s) at a similar level.

• Credible and confident communicator (written and verbal) at all levels.

• Strong analytical problem-solving ability with excellent attention to detail with the ability to work accurately in a busy and demanding environment.

• Hands-on approach with a can do attitude.

• Ability to prioritize demonstrating good time management skills.

• Self-motivated with the ability to work proactively using own initiative.

• Committed to learning and development.

• Interacts with all levels of BeOne employees

• Undertake any other duties as required.

Education/Experience Required:

• Bachelors or above in Chemistry Biochemistry or Biotechnology related scientific discipline.

• Minimum of 4 years of working experience in an FDA-regulated biotechnology pharmaceutical company are required.

• Familiar with Waters Empower Chromatography Data System.

• Familiar with instrument and equipment validation. Impressive demonstrable track record and skills/experience gained within a similar position(s) at a similar level. Working knowledge with USP/EP and cGMP/EU GMP regulations.

• 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.

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%

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 .