Manager QC Chemistry, US site

BeiGene 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 :

Supervises all QC Chemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA / EU regulations, applicable International Regulations, BeiGene processes and procedures. Establishes and implements QC Chemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the QC Chemistry laboratory.

Essential Functions of the job :

• Lead the new QC Chemistry laboratory set up.
• Oversee QC Chemistry laboratory related quality systems to ensure conformance with regulations and BeiGene Global quality standards.
• Supervise a highly efficient QC Chemistry team. Identify and develop key talents.
• Manage QC Chemistry laboratory routine operations, including but not limited to validation, SOPs, specifications, testing records, personnel training and assessment, scheduling, etc.
• Execute laboratory bench work as required.
• Ensure Chemistry laboratory compliance with Environmental Health and Safety (EHS) standards.
• Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations.
• Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
• Implementation of effective corrective actions and preventive actions (CAPAs).
• Participate in internal and external GMP audits where possible.
• Manage QC Chemistry method transfers and method validation activities, including transfer / validation strategy and approval of protocols and reports.
• Ensure that the QC Chemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.
• Undertake any other duties as required.

Core Competencies, Knowledge and Skill Requirements

Significant Contacts

Supervisory Responsibilities :

Computer Skills :

Other Qualifications :

Travel :

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

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

BeiGene 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 BeiGene 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.

Salary : $108,100 - $148,100