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:
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
Proficiency in calibrating and troubleshooting a variety of laboratory instruments.
Working knowledge and experience with laboratory instrumentation, such as GC, HPLC, UPLC, titrators, Raman, UV spectrophotometer, FTIR, PCR, etc.
Working knowledge of laboratory operations and workflows in the pharmaceutical industry.
Working knowledge with USP/EP, ICH Guidelines and cGMP/EU GMP.
Strong knowledge of regulatory requirements for data management and compliance.
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.
Significant Contacts
Interacts with all levels of BeOne employees.
Supervisory Responsibilities: N/A
Experience/Education Required:
Bachelor of Science degree and 5+ years of experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility required.
Bachelor’s in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, Engineering or related scientific discipline preferred.
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.
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 accommodationsus@beonemed.com.