Biotechnologist

ESCO ASTER PTE LTD; Singapore; On-site; SGD 28,000 - 42,000; Full time

Job summary

Esco Lifesciences Group unit Esco Aster Pte Ltd in Singapore is seeking a Manufacturing Documentation & Materials Associate to support daily aseptic, cGMP manufacturing activities. Fresh graduates are welcome; a Diploma or Bachelor's in Biotechnology, Chemical Engineering or Pharmaceutical Science is preferred.

You will handle batch records, SOPs, and material movements with GDP discipline. Join a team working with QA/QC/MSAT to ensure compliant operations and readiness of raw materials and

Qualifications

• Minimum Diploma or Bachelor’s Degree in Biotechnology, Chemical Engineering, Pharmaceutical Science or a related discipline.
• Good documentation skills and attention to detail; interest in manufacturing and inventory documentation.
• Proactive, able to work independently and in a team; proficient with MS Office.
• Fresh graduates welcome; prior cGMP/biologics experience is a plus but not required.

Responsibilities

• Support day-to-day manufacturing activities in a single-use, aseptic, cGMP facility.
• Maintain accurate manufacturing documentation and data entry in GDP.
• Prepare and maintain inventory and material movement documentation; manage raw materials and consumables.
• Assist with manufacturing documentation: batch records, SOPs, protocols, and cGMP documents.
• Support change controls, deviation investigations, CAPAs and other quality activities.
• Support QC sampling and process-related activities; assist with cell culture, purification, fill-finish as needed.
• Ensure readiness of materials, equipment and documentation for manufacturing activities.
• Collaborate with QA, QC and MSAT to maintain cGMP compliance.

Skills

Documentation skills

MS Office proficiency

Communication skills

Teamwork

Education

Diploma/Bachelor in Biotechnology or related (Biotech/Chemical Eng/Pharmaceutical Sci)

Tools

MS Office Suite

Job description

Esco Lifesciences Group is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.

Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.

Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.

Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.

Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.

We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.

The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.

Join us as we redefine BioSolutions for One World and One Health for the current and future generations to come.

One World Biosolutions for One Health.

Who we’re looking for

Physical / Mental Requirements / Work Environment:

• Ability to stay focused under pressure and adapt proactively.
• Critical thinker with a systematic and meticulous approach.
• Curious and self-motivated to stay updated on cell/gene therapy and emerging technologies.
• Committed to safety, quality, compliance, and timely delivery.
• Willingness to work in cleanroom and GMP manufacturing settings.
• Physically fit and able to handle and move materials/media weighing 20 kg or more as part of a two-person lift, where required.
• May engage in overtime during campaign activities or urgent troubleshooting.

The Scope

To support manufacturing activities for cell and gene therapy products in a cGMP environment, with a primary focus on manufacturing documentation, material and inventory management, process support, and ensuring compliance with Good Manufacturing Practices.

Primary work location: Ayer Rajah Crescent, Singapore

Job Responsibilities

• Support day-to-day manufacturing activities in a single-use, aseptic, cGMP facility.
• Maintain accurate and timely manufacturing documentation and data entry in accordance with Good Documentation Practices (GDP).
• Prepare and maintain inventory and material movement documentation, and support the management of raw materials and consumables.
• Assist with manufacturing documentation, including batch records, SOPs, protocols and other cGMP-related documents.
• Support manufacturing change controls, deviation investigations, CAPAs and other quality-related activities as required.
• Support QC sampling and other process-related activities as required.
• Support cell culture, purification, and fill-finish operations as required.
• Assist with ensuring the readiness of raw materials, equipment, documentation and other requirements for manufacturing activities.
• Work closely with internal teams including QA, QC and MSAT to support manufacturing activities and maintain compliance with cGMP requirements.
• Develop an understanding of cleanroom concepts, aseptic practices and cGMP requirements.
• Undertake other tasks as assigned by management based on project and manufacturing needs.

Requirements

• Minimum Diploma or Bachelor’s Degree in Biotechnology, Chemical Engineering, Pharmaceutical Science or a related discipline.
• Fresh graduates are welcome to apply. Previous experience in cGMP, biologics, cell and gene therapy or a manufacturing environment is preferred but not required.
• Good documentation skills and attention to detail, with an interest in working with manufacturing and inventory-related documentation.
• Proactive and willing to take initiative in completing assigned tasks.
• Able to work independently while also being a good team player in a dynamic environment.
• Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
• Good written and verbal communication skills.
• Experience in cell and gene therapy manufacturing or other cGMP manufacturing environments is an added advantage.