Senior Drug Substance Process Lead – mAbs

Advanced Manufacturing Tech Solutions; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Advanced Manufacturing Tech Solutions (AMTSOL) in Singapore seeks an experienced Process Engineering SME / Lead – Drug Substance to drive the design and delivery of a major biopharmaceutical manufacturing project.

You will serve as technical SME for mAbs Drug Substance process systems, collaborating with engineering teams, equipment vendors, Operations, C&Q, and project stakeholders to deliver compliant, safe, and cost-effective solutions.

Qualifications

• Strong pharmaceutical/biopharmaceutical process engineering experience.
• Proven experience in mAbs / Drug Substance manufacturing.
• Solid knowledge of upstream and/or downstream bioprocessing systems.
• Experience with bioreactors, chromatography, TFF, and buffer/media systems.
• Experience with CAPEX, greenfield, brownfield projects.
• Strong GMP engineering, URS, DQ, and C&Q knowledge.
• Experience with engineering contractors and equipment vendors.
• Strong technical leadership and stakeholder management.
• Background: Senior Process Engineer / Process SME / Drug Substance SME / Bioprocess Engineering Lead.

Responsibilities

• Provide technical leadership for Drug Substance / mAbs process systems.
• Translate process requirements into engineering design deliverables.
• Develop URS, DQ, technical specifications, and equipment package documentation.
• Support engineering design reviews and Design Assurance activities.
• Review vendor submissions and assist equipment selection.
• Participate in HAZOP, SWIFT, LOPA and risk assessments.
• Drive value engineering while maintaining GMP, safety and operability.
• Collaborate with engineering contractors, vendors, Work Package Owners, and C&Q teams.
• Ensure GMP, GEP, SHE and maintainability in design.
• Act as the project SME for assigned Drug Substance process areas.

Skills

Biopharmaceutical Process Engineering

MAbs Drug Substance

Upstream/Downstream Bioprocessing

Bioreactors

Chromatography

TFF

GMP URS DQ CQ Knowledge

Vendor Liaison

CAPEX/Greenfield/Brownfield

Leadership & Stakeholder Mgmt

Job description

Advanced Manufacturing Tech Solutions (AMTSOL) in Singapore seeks an experienced Process Engineering SME / Lead – Drug Substance to drive the design and delivery of a major biopharmaceutical manufacturing project.

You will serve as technical SME for mAbs Drug Substance process systems, collaborating with engineering teams, equipment vendors, Operations, C&Q, and project stakeholders to deliver compliant, safe, and cost-effective solutions.