Senior Analyst, QC Chemistry

BeiGene; Hopewell (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

BeOne is seeking a QC Chemistry Analyst to execute routine and non-routine testing in support of GMP manufacturing. The role involves generating timely test results for in-process, release, and stability programs, and ensuring compliance with internal procedures.

The ideal candidate has 4+ years' FDA-regulated lab experience, familiarity with HPLC/UPLC and related QC practices, and a strong attention to detail.

Qualifications

• BS degree in Chemistry/Biochemistry/Biotechnology or related field.
• 4+ years of FDA-regulated biotech/pharma lab experience.
• Experience with GMP, GMP audits/inspections.
• Experience with analytical data review and reporting.
• Familiarity with OOS investigations and CAPAs.

Responsibilities

• Perform routine and non-routine testing using HPLC, UPLC, UV-Vis, and other techniques to generate compliant results for release and stability testing.
• Review, interpret, and report analytical data per GMP and internal procedures.
• Investigate OOS events and lab discrepancies, and implement CAPAs.
• Participate in method transfer and validation activities, including protocols and reports.
• Maintain instrument qualification, SOPs, and data records; manage lab inventory.
• Train junior analysts and ensure adherence to quality systems.

Skills

HPLC

UPLC

UV-Vis

Capillary electrophoresis

GMP

OOS investigations

CAPA implementation

Education

Bachelor's degree in Chemistry/Biochemistry/Biotech

Tools

Waters Empower CDS

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.

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. 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 t