Manager, QC Analytical Instrument Operations, US Site (Hopewell, NJ)

Quality Control Laboratory Manager

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.

Manages all Quality Control (QC) laboratory instrumentation 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 to support GMP manufacturing, ensuring the accuracy and reliability of laboratory instruments to minimize downtime.

Essential Functions of the Job :

• Manage / perform the calibration, verification, and qualification of basic laboratory instruments and equipment, including but not limited to balances, pH meters, centrifuges, etc.
• Provide dedicated support for equipment life cycle management- calibration and maintenance scheduling, and documentation
• Management of vendor contracts and relationships for equipment needing specialist service, including but not limited to HPLC, GC, spectrophotometers.
• Ensure all calibration activities comply with regulatory guidelines (e.g., cGMP, USP / EP, etc.).
• Maintain detailed records of calibration, maintenance, and repair activities, including calibration certificates and reports.
• Support the qualification of new laboratory instruments, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Generate and review qualification protocols and reports.
• Manage the inventory of calibration standards and supplies.
• Perform routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, specifications generation and revision, record keeping, etc.
• Lead investigations of equipment out-of-tolerance (OOT), discrepancies, errors, and failures.
• Implement corrective actions and preventive actions (CAPAs).
• Assist in the preparation for internal and external GMP audits related to instrument calibration.
• 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 :

Significant Contacts :

Supervisory Responsibilities : N / A

Experience / Education Required :

Salary Range : $108,100.00 - $148,100.00 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 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.