Now Hiring: DS Manufacturing Engineer - Bioconjugation

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 3 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