Associate Manufacturing Engineer - Purification/Bioconjugation

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 45,000 - 60,000; Full time

Job summary

A leading biopharmaceutical firm in Singapore is seeking a candidate for bioconjugation reactions and purification of antibody intermediates. The ideal applicant has a Diploma or Degree in a relevant field, with 3-5 years of experience. Responsibilities include ensuring compliance with quality standards in drug substance manufacturing operations. Candidates should possess strong communication skills and the ability to adapt to a GMP cleanroom environment. This role may require temporary assignments, including overtime.

Qualifications

• Min 3-5 years of relevant working experience.
• Ability to adapt to a GMP cleanroom environment.
• Willingness to accept temporary work assignments and overtime.

Responsibilities

• Perform bioconjugation and purification of antibody intermediates.
• Monitor and ensure compliance with quality and safety regulations.
• Communicate and resolve production inconsistencies.

Skills

Scientific reasoning

Methodical work habits

Communication ability

Strong work ethic

Education

Diploma or Degree in Biological, Chemical, Pharmaceutical Engineering

Job description

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.