Manufacturing Principal Engineer - Purification/Bioconjugation

Responsibilities

• Bioconjugation Reactions and Purification of Antibody Intermediates and Conjugated Drug Substances
• Perform downstream protein purification manufacturing operations for drug substances under the guidance of SOPs. This includes, but is not limited to, chromatography system operation, conjugation, low pH viral inactivation, nanofiltration, ultrafiltration washing and filtration, and final bulk dispensing.
• Operate equipment and appliances following SOPs and relevant documents.
• Prepare relevant documents, such as production batch records, SOPs, and validation reports.
• Communicate and resolve inconsistencies and/or anomalies in production operations.
• Monitor processes, including real-time review of process parameters and data/trends.
• Ensure that drug substance manufacturing operations comply with quality and safety regulations.
• Perform other tasks assigned by leadership.
• Participate in shift production as required and ensure that shift production meets SOP requirements.

Requirements

• Diploma or Degree in Biological, Chemical, Pharmaceutical Engineering, or other related specialties with min 3-5 years of relevant working experience
• Possess thorough scientific reasoning and methodical work habits, with strong execution and planning abilities.
• Ability to adapt to a GMP cleanroom environment, including the requirement to wear dust-free clothing, masks, and goggles.
• Possess good communication ability and comprehension ability.
• Display a good working attitude, strong work ethic, and willingness to follow leadership directives.
• Be open to accepting temporary work assignments, including overtime on weekends or weekdays, and other roles as required.