Job Description

The Opportunity Esco Lifesciences Group provides enabling technologies, products and services to the life sciences and healthcare industries, supporting academic research and scientific discoveries, clinical practice, as well as biopharmaceutical R&D and manufacturing. Headquartered in Singapore, Esco has an extensive sales network in over 100 countries, direct sales and service offices in over 24 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1500 employees worldwide. Esco is poised to benefit from the sustained growth of the healthcare and biopharma industries in Asia and globally. Esco has achieved market leadership in China, and globally, in multiple categories within some of the fastest-growing segments \xe2\x80\x94 with China being its largest and fastest growing market. As a Singapore-headquartered company, Esco is a nexus of East and West, bridging technologies, products and talent across the world, with global operations spanning the US, Europe and Asia. The Scope You will be part of Esco Aster\xe2\x80\x99s Manufacturing team and contribute to the overall site mission and objectives. You will ensure pharmaceutical operation activities and tasks are planned and executed in an efficient and compliant manner, while adhering to cGMP standards. You will work with the Leadership team of Manufacturing to develop a continuous improvement mindset and engage in teamwork with cross-functional departments. We are looking for someone equipped who has excellent organizational skills and the ability to prioritize their workload to be part of our plant start up team. Primary work location: Ayer Rajah Crescent, Singapore Job Responsibilities
Safety

• Foster a safety-first mindset and adhere to company safety policies/procedures
• Identify and report potential safety issues or near-misses/hits
• Support the development of workplace safety risk assessments

General

• Perform activities that can include periods of rigorous, repetitive work
• Work in a cleanroom environment, wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work
• Maintain an organized and clean workspace

Quality

• Always ensure strict adherence to cGMP requirements.
• Follow GMP documents (SOPs, Batch Records) with strict adherence to safety and compliance
• Complete documentation (e.g. batch records, logbooks, deviation reports) following Good Documentation Practices / ALCOA principles
• Author, revise or review documents (e.g. SOPs, BRs and Logbooks)
• Perform timely review of documentation
• Support deviation investigation and implementation of CAPA

Operations

• Support process / equipment commissioning or qualification activities
• Operate process and analytical equipment per defined standard operating procedures (SOPs)
• Perform critical processes and in-process sampling per defined Batch Records (BRs)
• Ensure good housekeeping of production facility and equipment
• Adhere to daily production schedule
• Report and discuss with supervisors regarding any problem arising during the manufacturing process, which may lead to stoppages.
• Ability to perform basic troubleshooting
• Identify, recommend, and implement improvements

We are seeking individual with unique experiences in the respective fields and are also providing unique learning/training opportunities as well:
Production Support

• Perform production activities, including set-up, operation for the following, but not limited to:
  • Buffer and media preparation
  • Manual Cleaning
  • Filter Integrity Testing
  • Autoclaving

Drug Substance

• Perform production activities, including set-up, operation for the following, but not limited to:
  • Aseptic processing in Isolators and Biosafety Cabinets
  • Mixer Tanks
  • Incubators
• Perform in-process sampling and monitoring of cell culture process

Drug Product

• Perform production activities, including set-up, operation for the following, but not limited to:
  • High-speed filling machines
  • Isolators
  • Compounding tanks
• Dispense, compound, and fill active biological product.
• Perform in-process sampling on semi-finished drug products
• Perform visual inspection, labeling and packaging on semi-finished drug products.

Requirements

• Higher Nitec or Diploma in Biotechnology/Chemical/Mechanical Engineering and/or Life Sciences and/ or Biology
• Minimum 2 years of working experience in pharmaceutical manufacturing.
• Good knowledge in applying regulatory guidelines especially in manufacturing process
• Experience in a start up environment will be a plus
• Possess a continuous learning mindset
• Able to work in teams to complete operational tasks
• Able to maintain good working relationships with QA, QC and Engineering.
• Able to regularly lift up to 10 KG, push and pull objects that require up to 20 KG of force, and work on your feet for long durations

Apply now by submitting a Cover Letter and CV to jobs@escoaster.com.