Biochemist II - GMP Recombinant Protein Manufacturing

Job Summary

This GMP recombinant protein Biochemist at Bio Legend will primarily be responsible for performing protein purification, conjugation, formulation, and quality control for GMP product release. This position will assist in GMP protein manufacturing for GMP products. The position plays an important part in the success of the robust GMP recombinant protein product manufacturing and will actively support team members in managing raw material, inventory, and batch records through efforts collaborating with other departments such as manufacturing, quality assurance, and quality control teams.

This Biochemist will perform purifying recombinant proteins using various preparative chromatography methods and separation using methods such as IMAC, size exclusion, and ion exchange, conjugation and formulate the recombinant proteins according to standard operating procedures compliant with ISO and GMP regulation.

This position will also support a variety of cross-function manufacturing tasks including work order processing and closure of pilot lots related to product release or validation.

His/her role also assists in activities for technical support, document control, validation, training, nonconformance, and CAPA systems.

• Following standard procedures to conduct recombinant protein or antibody purification using affinity matrix such as IMAC and Protein A Sepharose.
• Following standard procedures to conduct protein conjugation and polishing using various types of chromatography and AKTA FPLC.
• Conduct the in-process quality testing such as purity analysis, endotoxin testing for the in-house made or customized bulk material of finished goods.
• Support internal safety and regulatory compliance audits
• Support equipment operation training and validation activities for new process and equipment validation
• Provide benchwork support for product releasing or troubleshooting of complicated manufacturing problems in recombinant protein production to ensure sustainable manufacturing design
• Support reviewing of quality system documents and corrective actions (NCR, or CAR) to ensure laboratory setting and procedures are in compliance with ISO
  9001:2008/ 13485:2016
• Proactively identify opportunities to improve current manufacturing procedures in order to increase efficiency and consistency to ensure QA compliance in traceability and equivalency.
• Other projects or responsibilities may be required.

• Bachelor of Science in Life Science or related area.

• Bachler's Degree in Life Science or related area with at least 2 years of working experience in related biotech protein or antibody product manufacturing.
• Extensive experience in protein or antibody purification.
• Experienced in purification and formulation of recombinant protein or antibody.
• Experienced in manufacturing under ISO/GMP environment.
• Demonstrated ability to be detail-oriented, organized and work well in small work groups
• Able to perform basic computer operations such as MS Office and Outlook and other computer-based software

While performing the duties of this job, the employee regularly works in a laboratory environment with occasional data entry on a computer. Occasional exposure to a warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.

The…