Target Onboarding:
September 2026
Location:
Singapore (Biopharmaceutical Manufacturing Operations)
Job Description
We are seeking a
Technical Specialist
to support our core biopharmaceutical manufacturing operations on a contract basis across three critical phases:
Operational Readiness, Run, and Release
. In this role, you will play a pivotal part in supporting seamless technology transfers, driving continuous operational reliability, and leading complex deviation investigations to ensure timely product release.
Key Responsibilities
1. Operational Readiness
Support technology transfers and process campaigns by developing and revising Master Batch Records (MBRs), Change Requests (CRs), and operational documentation.
Manage operational risk assessments, facilitate pre-campaign training sessions, and ensure all readiness tasks are fully executed prior to campaign startup.
2. Operational Run
Support the evaluation of manufacturing deviations within the Deviation Review Board (DRB).
Manage CAPAs, Change Control System Requests (CSCCs), rejected material processes, and associated campaign tasks.
Participate actively in audits and quality reviews focused on manufacturing process and deviation topics.
3. Operational Release
Lead technical deviation investigations and trend analyses to identify root causes using structured problem-solving methodologies.
Conduct precise product impact assessments and design effective CAPAs to support the timely disposition and release of manufactured lots.
Requirements
Experience & Knowledge:
Strong understanding of biopharmaceutical/pharmaceutical manufacturing processes and hands-on operational knowledge of manufacturing equipment.
Technical Competencies:
Proven experience in technical writing, root cause analysis (RCA), and managing Quality Management System (QMS) elements (Deviations, CAPAs, Change Controls).
Soft Skills:
Excellent verbal communication and presentation skills.
Adaptability:
High degree of agility to manage shifting deliverables and dynamic operational priorities.
At Anter Consulting, we offer bespoke strategic consultation. We promise unrivalled market knowledge and an extensive network of exceptional candidates.
We focus on delivering tailored solutions, through attentive consultancy services for your team, and finding the right people for your business.