Manager QC Chemistry, US site
BeiGene
**_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_**
+ Scientific degree (ideally in Chemistry, molecular biology, biotechnology or related).
+ Minimum of 5-4 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
+ Working knowledge and experience with Chemistry analytical methods such as size exclusion chromatography, capillary electrophoresis, cIEF, oligo and peptide mapping as well as instruments such HPLC, UHPLC, Capillary Electrophoresis, etc.
+ Knowledgeable with USP/EP and cGMP/EU GMP regulations.
+ Familiar with instrument and equipment validation.
+ Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry.
+ Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
+ Credible and confident communicator (written and verbal) at all levels.
+ Strong analytical and problem-solving ability.
+ Excellent project management skills.
+ 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 BeiGene employees;
**Supervisory Responsibilities:**
+ Manage direct reports within the QC Chemistry laboratory.
**Computer Skills:**
+ Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
**Other Qualifications:**
No
**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.
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