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Manufacturing Manager - Purification

Salary undisclosed

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Work Location: Tuas Biomedical Park

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

Responsibilities:

As a shift leader, you will be responsible for performing 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 SOPs and relevant documents.
  • Prepare and review 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 manufacturing operations of drug substances comply with quality and safety regulations.
  • Complete other tasks assigned by superiors.
  • Participate in shift production as required, ensuring compliance with SOP requirements.
  • Train junior employees and SMEs to meet GMP manufacturing requirements.
  • Communicate with relevant departments and lead cross-functional discussions of issues during manufacturing.
  • Participate in agency and client audits as a technical SME.

Qualifications:

  • Diploma or above in Biological, Chemical, Pharmaceutical Engineering, or related fields; more than 5 years of protein purification and conjugation experience and at least 3 years of management experience, with experience leading multiple manufacturing teams preferred.
  • Extensive experience with technical transfer, facilities fit, and gap analysis of antibody and recombinant protein projects.
  • Ability to participate as an expert during agency and client audits.
  • 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.
  • Good communication skills in Mandarin and English, with strong pressure tolerance.

Career Development:

  • Through comprehensive systematic training, you will quickly grow into a production-scale cell culture technology expert.
  • Performance-oriented promotion system and XDS department's unique growth incentive plan will help your career development, regardless of educational background.
  • Enhance your management skills, grow with the team, and pave the way for a successful career.
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