Senior Biologics Process Development Engineer

Nusantara Prime Consulting Pte. Ltd.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Performance bonus

Job summary

Nusantara Prime Consulting Pte. Ltd. seeks a Senior Process Development Engineer to support new product introductions and technology transfers for commercial biologics manufacturing.

You will independently drive NPI workstreams, provide expert technical leadership to the PD team, and ensure readiness for PPQ with a focus on process characterization and risk mitigation. The role requires deep biologics process knowledge, manufacturing experience, and strong scientific judgment to resolve

Qualifications

• Master’s Degree and 4 years of directly related experience OR Bachelor’s / Advanced Degree in Engineering, Science or related field and 6+ years of directly related experience.
• 6+ years of relevant work experience in the commercial manufacturing environment within biotechnology or pharmaceutical industries.
• At least 4 years’ experience with regulated environments (i.e. cGMP) required.
• In depth cell culture and/or purification process knowledge, including single-use technologies and harvest technologies.
• Strong communication skills (technical writing and verbal communication/presentation).
• Ability to independently determine when additional resources are required to solve problems.
• Ability to lead small team and lead projects.

Responsibilities

• Independently lead assigned NPI and technology-transfer technical workstreams, including process knowledge transfer, facility/process fit assessment, technical documentation and risk identification.
• Translate process characterization, scale-up and manufacturing knowledge into ASM requirements and support readiness for engineering runs and PPQ.
• Identify technical gaps and risks, develop recommendations and mitigation options, and elevate key decisions through the designated Technology Transfer Lead and PD leadership.
• Provide scientific and engineering support to the commercial PD team for cell culture, harvest and/or purification processes.
• Evaluate manufacturing performance and complex process issues using process knowledge, historical experience and engineering principles to develop technically sound recommendations.
• Partner with Manufacturing, Quality and other technical functions to resolve process challenges and support reliable commercial manufacturing.
• Lead or provide senior technical guidance for complex deviation investigations, including hypothesis development, data assessment, root cause evaluation and technical impact assessment.
• Integrate process, equipment, manufacturing and historical data to develop scientifically justified conclusions and risk-based recommendations.
• Coach PD engineers in structured problem solving, investigation strategy and clear technical communication to Manufacturing, Quality and leadership.
• Any other tasks as assigned by the supervisors.

Skills

Process development

Technology transfer

cGMP

Cell culture

Purification processes

Problem solving

Technical writing

Leadership

Cross-functional collaboration

Education

Master’s Degree in Engineering/Science

Bachelor’s/Advanced Degree in Engineering/Science

Job description

Nusantara Prime Consulting Pte. Ltd. seeks a Senior Process Development Engineer to support new product introductions and technology transfers for commercial biologics manufacturing.

You will independently drive NPI workstreams, provide expert technical leadership to the PD team, and ensure readiness for PPQ with a focus on process characterization and risk mitigation. The role requires deep biologics process knowledge, manufacturing experience, and strong scientific judgment to resolve