Perform QC sampling and chemistry testing of raw materials under FDA/EU regulations, applicable International Regulations, processes and procedures to support GMP manufacturing.
Essential Functions of the job:
Perform compendial (USP/EP) testing of raw materials (starting materials, excipients, primary packaging, manufacturing water).
Perform QC sampling and chemistry laboratory testing of raw materials (starting materials, excipients, primary packaging, manufacturing water) to ensure timely generation and reporting of test results in support of manufacturing operations.
Perform routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, specifications generation and revision, raw material sampling and testing, record keeping, etc.
Support QC sample management with the receipt of in-process samples and issuance of controlled documentation
Manage receipt and inventory of reagents and supplies for the laboratory.
Participate in internal and external GMP audits where possible.
Undertake any other duties as required.
Skills:
Core Competencies, Knowledge, and Skill Requirements
Scientific degree (ideally chemistry, biochemistry, biotechnology or related).
Working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
Working knowledge and experience with raw material sampling in a cleanroom environment.
Working knowledge and experience with physiochemistry analytical methods such as HPLC, GC, TOC, FTIR/NIR/Raman, Karl Fischer, osmolality, melting point, optical rotation, and wet chemistry compendial methods.
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.
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)
Education:
Education Required:
Minimum of 2+ years with a Bachelor's or above in Chemistry