(CW) QC Analyst Contract

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia, PKU (phenylketonuria), CLN2 (a form of Batten disease), and several forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few options. With the recent acquisition of Amicus, our portfolio now includes therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and scaling production for the commercial market. This team of engineers, technicians, scientists, and support staff builds and maintains cutting-edge manufacturing processes, ensures quality assurance and control to meet regulatory standards, and coordinates the global movement of our drugs to patients.

This is a contract role with a shift schedule of Wednesday through Saturday (onsite 4 days), swing shift (1:00 PM – 11:30 PM).

Purpose

The Quality Control Analytical In-Process (QCA-IP) Analyst performs analytical test methods on in-process intermediates and drug products under minimal supervision and within cGMP guidelines to support manufacturing of commercial and clinical therapeutics. This role involves expertise in analyses such as protein determination by A280, Bradford, UV Absorbance, enzyme activity, HPLC/UPLC, and method validation.

Responsibilities

• Facilitate timely receipt and accessioning of incoming samples, decipher batch assignments across assay types following best practices.
• Execute analytical methods for in-process testing under cGMP guidelines and report results promptly to meet internal customer timelines.
• Evaluate assay validity, calculate and summarize results, and analyze data against expected or specification ranges.
• Assist in compiling and verifying trend analysis reports.
• Collaborate on general housekeeping activities and maintain laboratory systems to ensure inspection readiness.
• Monitor and control laboratory supply and critical reagent inventories.
• Qualify as a trainer for specified methods and provide training to less experienced staff.
• Proactively communicate compliance risks and deviations, initiating investigation records within required timeframes.
• Support test method validation, investigations, technical studies, and method transfer protocols.
• Attend team huddles and department meetings, contributing ideas for laboratory infrastructure improvements and method optimization.
• Identify opportunities to improve operational excellence by reducing non-value-added activities and increasing process efficiency.
• Perform other responsibilities as assigned.

Qualifications

• Bachelor of Science degree.
• 0-3 years of relevant laboratory experience; QC-specific experience preferred.
• Experience with quality management systems, current Good Manufacturing Practices (cGMP), and QC principles.
• Demonstrated working knowledge of certified functional activities.
• Strong documentation, written, and verbal communication skills.
• Ability to perform tasks with minimal supervision.
• Computer literacy with proficiency in Microsoft Word, Excel, and PowerPoint.
• Familiarity with BINOCS or similar scheduling systems is preferred.
• Familiarity with SAP or similar enterprise systems is preferred.
• Quality service attitude, flexibility, and willingness to work additional hours to meet production or laboratory process requirements.

Schedule

• Wednesday – Saturday (onsite 4 days), swing shift (1:00 PM – 11:30 PM).