DS Manufacturing Engineer - Bioconjugation

Company not disclosed

Tuas, West Region, Singapore
Salary not specified
Posted
Full-time
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Job Description

Job Responsibilities 1. Manufacturing Operations & Process Execution - Execute manufacturing operations in compliance with SOP and MBR requirements, ensuring activities are completed as scheduled and all records are completed accurately and timely. - Perform drug conjugation reactions, purification, weighing, sampling, and sample management activities. - Operate and support equipment related to conjugation and purification processes to ensure safe and efficient manufacturing operations. 2. Equipment Qualification & Facility Support - Participate in FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and IOPQ (Installation, Operational, and Performance Qualification) activities. - Support workshop and facility maintenance to ensure production equipment and facilities operate as intended and meet operational requirements. 3. Quality Compliance & Documentation - Draft, review, and maintain SOPs and relevant process documentation according to leadership direction. - Support activities related to deviations, change control, audits, and other quality system processes as assigned. - Participate in and support internal and external audits and inspections, providing documentation and operational support as required. - Utilize and maintain records within electronic systems, including MasterControl, LIMS, MDH, OneBPM, and other applicable systems. 4. Leadership & Team Support - Act as supervisor delegate in the absence of the supervisor, ensuring continuity of operations and task coordination. - Support team leadership to ensure smooth daily operations, including shift execution and task alignment. - Represent the team in communication with internal and external stakeholders, ensuring alignment on operational and quality-related matters. - Support project production readiness, including participation in project scheduling activities. - Assist in drafting and reviewing solution lists and Bill of Materials (BOM) to ensure timely material and resource availability. 5. Other Responsibilities - Complete other ad-hoc or interim tasks assigned by leadership to support operational and business needs. Requirements - Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field. - Minimum of 1-2 years of hands-on experience in biopharmaceutical manufacturing. Priority consideration accorded to candidates with proven senior-level expertise in antibody manufacturing processes. - Familiar with GMP regulatory requirements and expectations of HSA, FDA, China NMPA, EU, and ICH guidelines. - Solid understanding of sterile pharmaceutical manufacturing processes and pharmaceutical quality systems. - Familiar with the application of Single-Use Technologies (SUT) in biopharmaceutical manufacturing. - Familiar with downstream processing and/or bioconjugation manufacturing processes. - Open to 12 hours shift schedules

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