Lead Engineer, MSAT - Purification

recruitmatic pte. ltd.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Pharmaceutical Company Singapore is seeking a Process Development/MSAT specialist to lead and support cell culture and purification operations at its Singapore facility. You will monitor processes, investigate deviations, update batch records, and mentor MSAT teammates while upholding data integrity and regulatory compliance.

Applicants should have 5+ years in biotechnology with a graduate degree in chemical/biochemical engineering or related field.

Qualifications

• 5+ years of biotechnology process development or related manufacturing experience.
• Experience in purification processes.
• Graduate degree in Chemical engineering, biochemical engineering, biochemistry/chemistry, or related field.

Responsibilities

• Lead preparation, execution, process monitoring, and post-campaign activities for cell culture or purification stages at the Singapore facility.
• Monitor processes regularly to identify issues and lead investigations across departments and customers.
• Review purification process batch records and provide input to technical writers; train operators.
• Update batch records to enable robust manufacturing operations; support GMP runs and investigations.
• Support APR and CPV summaries and assist BLA filing.
• Maintain data integrity and mentor MSAT team; uphold data policies.

Skills

Biotech experience

Process development

Purification domain exp

Education

Graduate degree in Chemical/biochemical Engineering or related field

Job description

My client is a big Pharmaceutical Company in Singapore.

What you will do:

• Process Support:Lead the preparation, execution, process monitoring, and post-campaignactivities for cell culture or purification stages of the customer’smanufacturing processes at Singapore production facility. Becomeproficient with all processes in the facility and develop the ability tosupport/lead activities across multiple processes.
• Monitor processeson a regular basis to further understand process behavior and prospectivelyidentify process issues. Develop the ability to generalize issues acrossprocesses. Lead investigations into process trends, issues, or deviationsinvolving multiple departments and customers. Write change requests and driveto implementation.
• Review purificationprocess manufacturing batch records and provide technical input to MFGtechnical document writing specialists. Identify training needs and providetraining materials for MFG operators on cell culture or purification processbatch records.
• Work with MFG toupdate process batch records to enable robust manufacturing operations. SupportGMP and commercial runs, perform technical investigations, and help authortechnical reports to support close-out of deviations, trouble-shoot processexcursions/issues for purification processes.
• Support Preparationof Annual Product Review (APR) and Continued Process Verification (CPV) summaryreports, perform work-stages to support customer BLA filing.
• Maintain processdatabases and monitor batch-to-batch consistency of operations. Supportinspections and audits by customers and regulatory authorities. Providetechnical mentorship and share process knowledge with MSAT team members andother departments. Uphold data integrity principles in accordance with policies. Proactively evaluate, identify, and improve the data integrityprocess. Any other duties as assigned by your Supervisor/Manager.

What we are looking for:

• Over 5 years of experience in biotechnology process development, process support, research, or a related manufacturing environment.
• Graduate degree in Chemical engineering, biochemical engineering, biochemistry/chemistry/biological science, or a related field.
• Prior experience in the purification domain.