About Next X Labs

Next X Labs LLC is seeking an experienced GMP QC Chemist to assist with the build-out of a scalable analytical testing lab supporting pharmaceutical product release, API batch release, and 503A stability studies.

Position Summary:

The Senior QC Chemist will serve as the technical leader for the Analytical Chemistry Laboratory at Next X Labs and play a critical role in establishing a world-class GMP analytical testing operation from the ground up.

During the laboratory startup phase, this individual will lead the selection, and IQ/PQ/OQ of analytical instrumentation; develop standard operation procedures (SOPs), training programs, support Quality Assurance initiatives, and serve as the chemistry technical expert during client and audit interactions as appropriate.

This position will be heavily focused on technical writing and equipment/process qualification during the initial build-out, completing product method development, routine testing, and coordinating with QA to support cGMP operations and ISO/IEC 17025 accreditation. As laboratory operations mature and validated methods are released for routine use, the role will transition into technical and operational leadership of the analytical QC chemistry group.

Responsibilities will expand to include:

-Supervision and professional development of QC analysts

-Oversight of sample scheduling and prioritization, lab workflow and throughput optimization

-Inventory management and equipment calibration/preventative
-Coordinating closely with QC Microbiology
-Supporting QC investigations

-Contribute to drafting and executing stability studies

-Expansion of test catalog to support business growth

Key Test Methods:

-HPLC/LC-MS identity, assay/potency, degradation, impurities, and related substances
-Gas Chromatography: Residual solvents
-Karl Fisher Titrator: Water determination

-pH, conductivity, and osmolality

-Willingness and ability to learn other analytical test methods to meet internal needs or support client requests.

Regulatory Knowledge:

Strong working knowledge of USP <621> Chromatography, <467> Residual Solvents, <1225> Validation of Compendial Procedures, <1224> Transfer of Analytical Procedures, <1058> Analytical Instrument Qualification, <41> Balances, <1251> Weighing on an Analytical Balance, applicable USP monographs, 21 CFR Parts 210/211, 21 CFR Part 11, FDA Data Integrity guidance, and familiarity with ISO/IEC 17025 is a plus.

Qualifications:

-Bachelor's degree in Chemistry or related science (Master's preferred).

- 7+ years of GMP pharmaceutical analytical chemistry experience.

-Strong technical writing and validation experience.

-Experience supporting regulatory inspections and client audits.

-Excellent communication and project management skills.

Compensation & Growth:

Competitive salary commensurate with experience, bonus eligibility, benefits, continuing education support, and advancement to Laboratory Manager or Director of QC Chemistry as Next X Labs expands.

Pay: $80,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Work Location: In person