Senior Analyst, QC Chemistry

BeiGene, Ltd.; Northern (KY); Hybrid; USD 91,000 - 126,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

FSA/HSA

Paid time off

Wellness program

Job summary

BeOne is seeking a QC Chemistry professional for its Hopewell, NJ site to support GMP manufacturing, testing, and release of materials and finished products. You will perform routine analytical testing, review data, and ensure compliance with GMP regulations.

The role requires strong expertise in QC and analytical methods, with experience in audits, data integrity, and CAPA. Join a globally expanding team focused on cancer therapies and patient access.

Qualifications

• Experience in QC within GMP environments.
• Hands-on with analytical methods such as HPLC, UPLC, UV-Vis, and other techniques.
• Capable of interpreting data and ensuring compliant reporting.

Responsibilities

• Perform routine and non-routine testing to support GMP manufacturing, testing, and release.
• Review and report analytical data per GMP and internal procedures.
• Lead CAPA investigations and participate in method validation activities.

Skills

HPLC/UPLC

GMP compliance

CAPA investigations

Data interpretation

Education

Bachelor’s or above in Chemistry or related

Tools

Waters Empower Chromatography Data System

Job description

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 Sr. 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 large molecule 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 and inspections, 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.

Qualifications and Experience

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.

Supervisory Responsibilities

Bachelor’s 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. 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.

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

$90,900.00 - $125,900.00 annually

Benefits

The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Equality and Diversity

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 [e-mail].

About BeOne

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.

Contact Information

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland.

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At BeOne, how we work is just as important as the work we do.

• Patients First
• Driving Excellence
• BOLD Ingenuity
• Collaborative Spirit