Chemist III/Sr. Chemist Raw Materials

• 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

• None

• →Direct Reports: No
• →Indirect Reports: None

• Manufacturing Operations
• Quality Assurance
• Analytical R&D
• Program Management

• 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

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.