Manufacturing Lead

Direct message the job poster from ESCO ASTER PTE LTD

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:

• Strong leadership and communication skills.
• 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.
• Cleanroom and GMP manufacturing settings.
• Requires standing for long periods, working with sterile systems, and wearing full gowning/PPE.
• May engage in overtime during campaign activities or urgent troubleshooting.

The Scope

To lead and manage the successful technology transfer, manufacturing execution, and commercial readiness of cell and gene therapy products in a cGMP environment, ensuring compliance, efficiency, and delivery excellence throughout the product lifecycle.

Primary work location: Ayer Rajah Crescent, Singapore

Job Responsibilities

• Lead cross-functional biotechnicians and act as the bridge between process development and manufacturing.
• Collaborate with internal/external stakeholders including QA, QC, MSAT, and commercial teams.
• Serve as Manufacturing Subject Matter Expert (SME) during audits, inspections, and due diligence.
• Manage end-to-end technology transfers (internal and external).
• Oversee execution of Process Performance Qualification (PPQ), Aseptic Process Simulations (APS), and engineering/pilot runs.
• Oversee cell culture, purification, and fill-finish operations in a single-use, aseptic, cGMP facility.
• Ensure readiness of raw materials, equipment, and team for autologous/allogeneic campaigns.
• Monitor, document, and troubleshoot manufacturing activities, ensuring compliance with SOPs and regulatory requirements.
• Author, review, and manage cGMP documentation: SOPs, batch records, risk assessments, protocols, etc.
• Lead manufacturing change control, deviation investigations and implement CAPAs.
• Lead the implementation of electronic batch records.
• Potentially leading a small team.
• Undertake other tasks as assigned by the management based on project needs.

Requirements

• Minimum Bachelor’s Degree in Biotechnology related disciplines, Chemical Engineering, Pharmaceutical Science or relevant discipline with 2 years or more experience in a cGMP/aseptic environment in biologics or cell and gene therapy.
• Minimum of 4-6 years in cGMP Biologics or cell and gene therapy manufacturing with relevant industry knowledge, hands on equipment experience and technical expertise.
• Strong knowledge of cGMP practices and global regulatory requirements such as USFDA GMP, EU GMP, HSA GMP and PIC/S GMP.
• In-depth knowledge of the drug development process and commercialization pathways.
• Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
• Able to work independently and task oriented in a dynamic environment.
• Strong team player with a strong set of interpersonal skills.
• Excellent written and verbal communication skills.
• Experience in bringing cell and gene therapy products through clinical development to market is an added advantage.
• Proven track record in regulatory strategy and interactions is an added advantage.

Apply now by submitting a Cover Letter and CV to .

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Management and Manufacturing