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 clients
Essential Functions- 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
Supervisory responsibilities- Direct Reports: No
- Indirect Reports: None
Key Relationships- Manufacturing Operations
- Quality Assurance
- Analytical R&D
- Program Management
Travel requirements:Education and Experience- 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, Skills, and Abilities- 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
Physical Demands and Work EnvironmentWhile performing the duties of this job, there may be certain physical demands required for the position.
- Requires frequent sitting and walking
- Requires carrying under 20 LBS, occasionally 20 - 60 LBS
- Requires pushing, & pulling under 20 LBS, occasionally 20-60 LBS
- Requires occasional bending, twisting, reaching, & gripping
- Requires constant seeing & hearing
Other DutiesYou may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and DisclaimerThe 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.
