Chemist III​/Sr. Chemist Raw Materials

Position Summary

– The Chemist III/Sr. Chemist Raw Materials ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and external client.

• Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules, stability pull dates and timelines.
• Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks.
• Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements
• Interact with third party laboratories for microbial and analytical testing of raw materials
• Generate and/or review shipping paperwork for third part testing and prepare samples for shipment.
• Create purchase requisitions for lab supplies and third-party testing
• Perform weekly laboratory audit inspections
• Perform sampling of raw materials as needed
• Review third party laboratory investigations and protocols.
• Execute intermediate to advanced chemical and instrumental testing of raw materials using HPLC, GC, FTIR, UV-Vis, Karl Fischer titration, and wet chemistry.
• Ensure all testing meets compendial standards (USP/EP/JP) and regulatory expectations. Conduct peer reviews of data, Certificates of Analysis (COAs), and laboratory logbooks.
• Author and review GMP documentation including Standard Operating Procedures (SOPs), protocols, deviations, Corrective and Preventive Actions (CAPAs), and change controls.
• Provide technical guidance to junior analysts. Lead method verification, validation, and method transfer activities for incoming raw materials.
• Oversee the calibration, maintenance, and troubleshooting of laboratory equipment.
• Other duties as assigned

• Direct Reports:
  No
• Indirect Reports:
  None

• Manufacturing Operations
• Quality Assurance
• Analytical R&D
• Program Management
• None

• Minimum BA or BS in a scientific discipline required
• Minimum 5-8 years of Analytical chemistry experience with a cGMP/GLP environment, preferably at a CDMO or pharmaceutical company.

• Knowledge of cGMPs
• Good communication, organization and computer skills are required.
• Knowledge of Empower required; LIMS and Microsoft Office programs knowledge is desired.
• Ability and willingness to work additional hours as required by business need
• At least 5 years’ experience in a CRO environment
• Experience with USP, EP and JP monographs.
• Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators (Volumetric and Coulometric), and Particle size.
• Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders
• Excellent verbal and written communication skills
• Ability to work with minimal supervision
• Experience in Data Review of Analytical data per GDP guidelines.
• Proven ability to review and evaluate the compliance and completeness of analytical data.
• Able to multi-task productively, applying time management processes and procedures effectively.
• Works toward common goals by supporting, encouraging, and sharing information with colleagues.
• Strong analytical skills and ability to understand business and financial implications of contracts
• Self-directed

While performing the duties of this job, there may be certain physical demands required for the position.

• Requires frequent…