ASSISTANT MANAGER
Date: Jan 20, 2026
Location: Johor bahru, MY
Company: bioconbiolP2
Company Overview
Role Purpose
Academic Stream
Work experience (in months)
Job Responsibility and key Decisions
Responsibilities
Lead MSAT USP, DSP DP activities for the assigned product group, including tech transfers, investigations, validation, and process improvements.
Serve as the technical SME for the product group, supporting site operations and crossfunctional project teams.
Drive root cause investigations and correctivepreventive actions CAPAs for deviations, Change controls, outoftrend OOT, and outofspecification OOS results.
Review technical documents such as process validation protocols, batch records, process development reports, and control strategies.
Collaborate with other PGs within MSAT and RD teams for new product introductions NPIs and postapproval changes.
Guide the implementation of new technologies and digital tools to enhance process understanding, performance and compliance.
Support audit and inspection readiness by ensuring robust documentation and control of critical processes.
Key Decisions
Approve technical strategies for all GMP campaigns such as developmentengg runs, clinical batches, process validation, scale up and tech transfer internal to external, internal and external to internal , and lifecycle management for the product group.
Decide on temporary or permanent process modifications based on risk and scientific justification.
Prioritize team workload and allocate resources for support activities across the product lifecycle.
Provide input on facility, equipment, and process changes with potential product impact.
Make recommendations for change controls, deviations, and regulatory commitments.
