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General Description:

Perform QC chemistry laboratory activities to support GMP manufacturing, testing and release of raw materials, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne's processes and procedures.

Essential Functions of the job:

+ Perform QC chemistry laboratory testing (e.g., raw material, DS, DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.

+ Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, testing record keeping, etc.

+ Manage inventory of reagents and supplies for the laboratory.

+ Lead investigations of OOS, discrepancies, errors, failures requiring documented review and action.

+ Participate in internal and external GMP audits, as needed.

+ Lead method transfer and method validation activities, prepare protocols and reports.

+ 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

+ 6+ years of experience with General education, 4+ years with Scientific degree (ideally chemistry, biochemistry, biotechnology or related). 2+ years’ experience with PHD.

+ 4+ years’ working experience in an FDA-regulated biotechnology, pharmaceutical company are preferred.

+ Working knowledge and experience with chemistry analytical methods such as HPLC, UPLC, GC, CE, IEF, TOC, UV, FTIR/NIR/Raman, Karl Fischer, osmolality, melting point, optical rotation, and wet chemistry compendial methods, etc.

+ Working knowledge with USP/EP and cGMP/EU GMP.

+ Familiar with instrument and equipment validation.

+ 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.

Computer Skills:

+ Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

Travel:

+ Must be willing to travel approximately 10%

+ Ability to work on a computer for extended periods of time

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.