Biochemist II - GMP Recombinant Protein Manufacturing

About the Role

This GMP recombinant protein Biochemist will primarily be responsible for performing protein purification, conjugation, formulation, and quality control for GMP product release. The position assists in GMP protein manufacturing and plays a key role in supporting robust recombinant protein product manufacturing. Responsibilities include collaborating with manufacturing, quality assurance, and quality control teams to manage raw material, inventory, and batch records.

Responsibilities

• Conduct recombinant protein or antibody purification using affinity matrix such as IMAC and Protein A Sepharose, following standard procedures.
• Perform protein conjugation and polishing using various types of chromatography and AKTA FPLC.
• Conduct in-process quality testing, including purity analysis and endotoxin testing for in-house or customized bulk material of finished goods.
• Support internal safety and regulatory compliance audits.
• Assist in equipment operation training and validation activities for new processes and equipment.
• Provide benchwork support for product release or troubleshooting of manufacturing problems to ensure sustainable production.
• Review quality system documents and corrective actions (NCR, CAR) to ensure compliance with ISO9001:2008/13485:2016.
• Identify opportunities to improve manufacturing procedures for increased efficiency, consistency, and QA compliance.
• Support cross-functional manufacturing tasks, including work order processing and closure of pilot lots related to product release or validation.
• Assist in technical support, document control, validation, training, nonconformance, and CAPA systems.

Requirements

• Bachelor of Science in Life Science or a related field.

Preferred Qualifications

• Bachelor’s degree in Life Science or related field with at least 2 years of experience in biotech protein or antibody product manufacturing.
• Extensive experience in protein or antibody purification and formulation.
• Experience manufacturing under ISO/GMP environment.
• Demonstrated ability to be detail-oriented, organized, and work well in small groups.
• Proficiency in basic computer operations, including MS Office, Outlook, and other software.

Work Environment & Physical Demands

This role primarily operates in a laboratory environment with occasional data entry on a computer. Occasional exposure to a warehouse environment may occur. The employee is regularly required to use hands and fingers to handle objects, tools, or controls and must frequently stand, talk, and hear.

Pay

The base salary range for this full-time position is $20.00 - $30.00 per hour. The final offer will consider internal equity, work location, and factors such as job-related skills, experience, and relevant education or training. This range does not include bonuses, equity, or other benefits, which may be applicable depending on the position level.

Benefits

• Medical, Dental, and Vision Insurance Options
• Life and Disability Insurance
• Paid Time-Off
• Parental Benefits
• Compassionate Care Leave
• 401k with Company Match
• Employee Stock Purchase Plan

Note: Benefits are available for eligible full-time roles. Part-time and temporary roles may not qualify for all listed benefits.