BeOne Medicines · 2 days ago
Manager, QC Analytical Instrument Operations, US Site (Hopewell, NJ)
Hopewell, NJ
Full-time
Onsite
Mid, Senior Level
$111K/yr - $151K/yr
5+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer, seeking experienced professionals for various roles. The Manager of QC Analytical Instrument Operations will oversee all Quality Control laboratory instrumentation and metrology activities to ensure compliance with GMP manufacturing and regulatory standards.
Pharmaceuticals
Responsibilities
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
Qualification
Required
Bachelor of Science degree and 5+ years of experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility required
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
Preferred
Bachelor's in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, Engineering or related scientific discipline
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase