Open to opportunities

Amir ishak

@amirishak

Message

I’m a bioprocess engineer combining cGMP production leadership with algal and microbial R&D for scalable yield.

Malaysia

Message

What I'm looking for

I’m looking for a bioprocess role where I can combine cGMP production discipline with R&D process optimization—driving yield, cost, and quality improvements through strong documentation, aseptic execution, and data-led continuous improvement.

I’m a bioprocess professional focused on turning biological processes into reliable, scalable outcomes—from cGMP production execution to upstream/downstream optimization in microalgae and microbial systems. I’m at my best when I can connect technical controls, data-driven process improvement, and practical delivery.

In my current role as a Senior Associate (Production Drug Product) at Biocon, I plan and coordinate daily shift activities to hit production targets while adhering to cGMP, SOP, and GDP standards. I ensure compliance in cleanroom operations, monitor and record critical parameters (differential pressure, temperature, humidity), and oversee cleaning, fumigation, and sterilization activities including autoclave operations and chamber leak tests.

I also drive quality and readiness across the production system: I manage documentation (batch records, logbooks, checklists), coordinate with QA/QC/Warehouse/Engineering to resolve production issues, and support equipment calibration. I lead aseptic operations such as filling machine assembly/disassembly and aseptic connections, while participating in equipment qualification, validation, continuous improvement, and SIT support with deviation investigation and CAPA implementation.

Previously, as a Lead Bioprocess Engineer at Hutanbio, I designed and developed integrated bioprocesses for algal biofuel production, optimizing growth conditions and engineering large-scale cultivation systems for efficient mixing, aeration, and nutrient delivery. I applied Box-Behnken design and Minitab to improve productivity and yield, developed downstream biomass recovery methods (flocculation, centrifugation, filtration), and implemented QC protocols for consistent biomass composition, lipid content, and fuel quality—experiences I’ve built further through research roles spanning Euglena/UTM and KAUST.

Experience

Work history, roles, and key accomplishments

Current

Senior Associate

Current

Biocon Sdn Bhd

Nov 2024 - Present (1 year 6 months)

Planned and coordinated daily production shift activities to achieve targets while ensuring cGMP/SOP/GDP compliance for drug product manufacturing. Led cleanroom aseptic operations, monitored critical parameters, and maintained batch documentation while coordinating with QA/QC, Warehouse, and Engineering to resolve production issues and support SIT/deviations and CAPA.

GDP Compliance Clean Room Operation CAPA

Scientist

Euglena Co., Ltd

Oct 2023 - Oct 2024 (1 year)

Optimized microalgae and fungi cultivation in bioreactor systems to improve growth efficiency and yield. Improved downstream harvesting/dewatering processes, developed photosensor technology to enhance photon capture and CO2 utilization, and supported scale-up of sustainable bioprocesses.

Microalgae Production Harvesting And Dewatering Downstream Processing Process Scale Up

Lead Bioprocess Engineer

Hutanbio (M) Sdn Bhd

Jun 2019 - Sep 2023 (4 years 3 months)

Designed and developed integrated bioprocesses for algal biofuel production, optimizing growth conditions and selecting cultivation system configurations. Engineered large-scale cultivation setups, applied Box-Behnken/Minitab for process optimization, developed downstream harvesting/dewatering methods, and implemented QC/monitoring for biomass composition, lipid content, and fuel quality.

Mixing Aeration Nutrient Delivery Statistical Design Of Experiments (Box Behnken)Minitab Downstream Harvesting And Dewatering Filtration

Research Scientist

Kyanos Biotechnology

Nov 2017 - Apr 2019 (1 year 5 months)

Developed and optimized algal biofuel bioprocesses, including selection of growth conditions and cultivation system strategies (open ponds and closed photobioreactors). Applied Box-Behnken modeling with Minitab, and established QC and process monitoring to maintain biomass composition, lipid content, and biofuel quality while improving harvesting and dewatering methods.

Algal Biofuel Bioprocess Development Cultivation System Design Open Ponds Photobioreactors Box Behnken Modeling Minitab Process Optimization Harvesting Dewatering (Flocculation Centrifugation Filtration)Process Monitoring

Research Assistant

Institute Bioproduct Development (IBD)

Jul 2015 - Oct 2017 (2 years 3 months)

Performed R&D to develop high cell density Pichia pastoris cultivation for Trypsin Modulating Oostatic Factor production, using OFAT and statistical optimization approaches. Conducted lab-to-1000L bioreactor scale-up, executed analytical testing (HPLC, GCMS, ICP-MS, spectrophotometry), and compiled reports for internal and external auditors.

Pichia Pastoris Cultivation High Cell Density Fermentation OFAT Optimization Response Surface Design (Box Behnken)ICP MS Spectrophotometry