Total 2 manufacturing production job vacancies in Singapore

Downstream Purification/Bioconjugation Engineer

Work Location: Tuas Biomedical Park

Shift work (including night shift) might be required based on production need

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 operation, nano filtration operation, ultrafiltration washing and filtration operation, and final bulk dispensing.
• 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 inconsistencies and/or anomalies in production operations.
• Monitor processes, including real-time review of process parameters, data, and trends.
• Ensure that the manufacturing operation of drug substances complies with quality and safety regulations.
• Complete other tasks assigned by superiors.
• Participate in shift production as required, ensuring compliance with SOP requirements.

Qualifications:

• Bachelor's degree or above in Biological, Chemical, Pharmaceutical Engineering, or related fields; more than 2 years of experience in antibodies purification or conjugation is preferred.
• Possess rigorous scientific thinking and habits, with strong execution and planning abilities.
• Adapt to the GMP cleanroom environment, wearing dust-free clothing, masks, and goggles.
• Good communication and comprehension abilities.
• Obey leadership arrangements, demonstrate a hardworking spirit and a positive work attitude.
• Accept temporary work requirements, such as overtime on weekends or weekdays and other tasks.

Career Development:

• Through comprehensive systematic training, you will quickly grow into a large-scale cell culture technology expert.
• Our performance-oriented promotion system and the unique growth incentive plan of the XDS department will help your career development, regardless of your educational background.
• Explore your management potential, advance alongside a dedicated team, and pave the way for a successful career.

Work Location: Tuas Biomedical Park

Responsibilities:

• Prepare buffers and media for drug substance manufacturing in compliance with GMP standards.
• Participate in and execute production projects, ensuring timely completion of production plans.
• Maintain and complete production records in accordance with GMP requirements.
• Assist in the drafting, revision, and improvement of SOPs, URS, PQ, and other relevant documentation.
• Perform additional tasks and responsibilities as assigned by leadership.

Qualifications:

• Bachelor’s degree or higher in biology, chemistry, pharmaceutical engineering, or related specialties, or equivalent work experience.
• Experienced in biopharma manufacturing process, including buffer / media preparation work.
• Understanding of the DS manufacturing process with strong GMP and compliance awareness.
• Excellent communication and presentation skills with the ability to handle stress.