Perform QC chemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, processes and procedures.
Essential Functions of the job:
Perform QC chemistry assay validation and transfer activities, including testing (e.g., 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, specification generation and revision, testing record keeping, etc.
Manage inventory of reagents and supplies for the laboratory.
Participate in laboratory investigations, including but not limited to OOS, Out of Trend, deviations, invalid assays, and associated corrective actions.
Participate in internal and external GMP audits where possible.
Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
Undertake any other duties as required.
Skills: Core Competencies, Knowledge, and Skill Requirements
Scientific degree (ideally chemistry, biochemistry, biotechnology or related).
Minimum of 2 years working experience in an FDA-regulated biotechnology or biopharmaceutical company are required.
Working knowledge and experience with Chemistry analytical methods for biological products (monoclonal antibodies), such as HPLC, UPLC, Container Closure Integrity (CCIT), Sub-visible Particles, N-glycan, UV spectrophotometer, including qualification, assay validation and transfer activities.
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.
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
Keywords:
Education: Education Required:
Minimum of 2+ years bachelor's or above in Chemistry, Biochemistry, Biotechnology, or related scientific discipline.
5+ years of experience preferred.
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