Drug Substance Manufacturing Senior Engineer

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading biopharmaceutical company in Singapore is seeking a technician to cultivate antibody intermediates in a GMP environment. Ideal candidates will have a diploma in relevant fields and experience with cell culture processes. The role offers comprehensive training and development opportunities, including potential for internal job rotation.

Benefits

Comprehensive in-house training program

Opportunity for career development and internal job rotation

Cross-cultural learning

Qualifications

• Candidates with equivalent work experience will also be considered.
• Ability to adapt to a GMP cleanroom environment.
• Good working attitude and strong work ethic.

Responsibilities

• Cultivate and express antibody intermediates in industrial-scale cell culture using single-use technologies.
• Perform GMP-compliant production tasks including cell culture management.
• Monitor processes and resolve anomalies during production operations.

Skills

Communication

Adaptability

Working attitude

Education

Diploma or higher qualification in Biological, Chemical, Pharmaceutical Engineering

Job description

Responsibilities

• Cultivate and express antibody intermediates in an industrial-scale cell culture platform using single-use technologies.
• Perform vial thawing, cell expansion and passage, cell culture, and harvest manufacturing in drug substance facilities in accordance with GMP requirements.
• Operate equipment and appliances following the guidance of SOPs and relevant documents.
• Prepare relevant documents, such as production batch records, SOPs, and validation reports.
• Communicate and resolve any inconsistencies and/or anomalies in production operations.
• Monitor processes, including real-time review of process parameters and process data/trends.
• Participate in shift production as required and ensure that shift production meets SOP requirements.

Qualifications

• Diploma or higher qualification in Biological, Chemical, Pharmaceutical Engineering, or other related specialties; candidates with equivalent work experience will also be considered.
• 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.

Career Development

• Comprehensive in-house training program (E-learning / OJT / Mentorship)
• Dual career development tracks – Professional & Managerial Tracks
• Opportunity for internal job rotation / Cross-BU transfer / Cross-country assignment
• Cross cultural learning
• GMP greenfield start-up experience