Scientist II, Manufacturing

We are seeking a detail-oriented Protein Manufacturing Associate to support the production of protein standards, protein blends, and dye-labeled proteins used in research, biotechnology, and diagnostic applications. This role is ideal for candidates with hands-on protein laboratory experience who enjoy working in a regulated manufacturing environment and are passionate about producing high-quality scientific products. The successful candidate will perform protein purification, characterization, and chromatography-based manufacturing processes while ensuring compliance with quality and documentation standards.

• Manufacture protein standards, protein blends, and dye-labeled proteins according to established production schedules and standard operating procedures (SOPs).
• Perform protein purification, protein characterization, and chromatography-based workflows to support manufacturing operations.
• Prepare buffers, reagents, and laboratory solutions required for daily production activities.
• Operate laboratory equipment including chromatography systems, centrifuges, spectrophotometers, pipettes, and other analytical instruments.
• Support routine equipment maintenance and ensure laboratory readiness.

• Analyze protein banding patterns, gel results, and protein intensity data to evaluate product quality and consistency.
• Identify subtle product variations, abnormalities, or deviations during manufacturing processes.
• Investigate manufacturing deviations, document findings, and support corrective and preventive actions (CAPA) when appropriate.
• Participate in continuous improvement initiatives to enhance manufacturing efficiency and product quality.

• Maintain accurate production records and complete manufacturing documentation in accordance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
• Ensure compliance with established quality systems, procedures, and regulatory requirements.
• Collaborate with Quality, Manufacturing, and Scientific teams to support successful product release and operational goals.

• Bachelor's degree in Biology, Biochemistry, Molecular Biology, Microbiology, Chemistry, or a related scientific discipline.
• 2+ years of laboratory, manufacturing, biotechnology, or research experience.
• Hands-on experience with protein-related techniques, including:
  Protein purification
• Protein characterization
• Protein assays
• SDS-PAGE or gel electrophoresis
• Chromatography methods
• Experience preparing laboratory buffers, reagents, and solutions.
• Strong attention to detail with the ability to recognize subtle differences in protein data and analytical results.
• Ability to follow detailed procedures while maintaining high levels of accuracy and documentation quality.
• Strong organizational, communication, and teamwork skills.
• Ability to manage multiple priorities in a fast-paced laboratory environment.

• Experience with resin chromatography, FPLC/AKTA systems, or related protein purification platforms.
• Knowledge of GMP, GLP, or regulated manufacturing environments.
• Experience reviewing analytical data and troubleshooting protein manufacturing processes.
• Familiarity with quality systems, deviation investigations, and documentation best practices.
• Experience working in biotechnology, life sciences manufacturing, or diagnostic product development environments.

• Protein Analysis
• Protein Purification
• Protein Characterization
• Resin Chromatography
• FPLC / AKTA Systems
• Buffer Preparation
• SDS-PAGE / Gel Analysis
• Laboratory Documentation
• GDP & GMP Compliance
• Spectrophotometry
• Quality Investigations
• Root Cause…