Associate Manufacturing Engineer – Cell Culture - #1114605

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.

●        Ensure that the manufacturing operations for drug substances 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 higher qualification in Biological, Chemical, Pharmaceutical Engineering, or other related specialties; candidates with equivalent work experience will also be considered.

●        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.

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