Cell Line Creation Scientist

ESCO ASTER PTE LTD; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

Esco Aster Pte Ltd in Singapore is seeking a seasoned Cell Line Development Lead to drive immortalization, cell banking, and characterization for therapeutic manufacturing. You will collaborate with clients and internal teams to ensure successful technology transfer and regulatory readiness.

The role requires leadership in GMP cell line workflows, with experience in transfection methods and regulatory documentation. Join a pioneering CDMO advancing cell-based products.

Qualifications

• Advanced degree with 5+ years in cell line development.
• Experience with GMP, MCB/WCB establishments.
• Expertise in hTERT immortalization and single-cell cloning.
• Ideally familiar with ICH guidelines for cell substrates.
• Proficient in data analysis and regulatory documentation.

Responsibilities

• Design and execute cell line creation strategies for primary human cell types and substrates used in therapeutic manufacturing.
• Lead immortalization programs from vector selection to cloning, expansion and stability.
• Evaluate and implement gene delivery methods for stable transgene introduction.
• Support client technology transfer for proprietary workflows as needed.
• Establish and qualify Master/Working Cell Banks per ICH Q5D and GMP.
• Define pre-cloning pool testing strategies and MCB characterization plans.
• Prepare and review cell banking protocols, batch records, and certificates of analysis.
• Design cell characterization programs covering identity, safety, and stability.
• Interpret data in regulatory context and assist with documentation.
• Maintain knowledge of FDA/EMA/PMDA guidance relevant to novel substrates.
• Act as internal SME and mentor, collaborate across teams.

Skills

Data interpretation

Protocol authoring

SOPs and batch records

Problem solving

Laboratory adaptability

Cell immortalization expertise

GMP MCB/WCB experience

ICH Q5A/Q5B/Q5D/Q6B knowledge

Non-viral and viral gene delivery

Excel data analysis

Excellent communication

Independent and team work

Education

Master or PhD in Cell Biology or related

Tools

STR profiling

Karyotyping

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

• Ability to read, analyze and interpret scientific data and publications.
• Ability to author or review protocols, technical reports and technology transfer documents.
• Ability to author and review standard operating procedures, batch records, protocols, data, reports and other related documents.
• Ability to define problems, collect data, establish facts, and draw conclusions.
• Repetitive motions due to certain laboratory techniques.
• Ability to adapt and keep up with rapid changes in a fluid and dynamic environment as this is a rapidly evolving space.

The Scope

You will be part of Esco Aster’s scientific division and contribute to the company’s CDMO mission by leading cell line development and characterization programmes for therapeutic manufacturing applications. Working closely with internal and external stakeholders, clients, and partners, you will drive activities related to cell immortalization, GMP-compliant cell banking, cell characterization, technology transfer, and regulatory support, while providing scientific leadership across client and development projects.

Job Responsibilities

Cell Line Development & Immortalization

• Design and execute cell line creation strategies for a range of primary human cell types and cell substrates used in therapeutic manufacturing.
• Lead immortalization programmes from vector selection and delivery through to single-cell cloning, expansion, and stability assessment.
• Evaluate and implement gene delivery methods (viral and non-viral) for stable transgene introduction.
• Support client technology transfer activities related to proprietary cell line creation workflows, as required by project scope.

Cell Banking (MCB/WCB)

• Establish and qualify Master Cell Banks and Working Cell Banks in compliance with ICH Q5D and applicable GMP guidelines.
• Define pre-cloning pool testing strategies and MCB characterisation plans with appropriate risk-based justification, in alignment with ICH Q5A and Q5B requirements.
• Prepare and review cell banking protocols, batch records, and certificates of analysis.

Cell Characterisation & Safety Testing

• Design and oversee comprehensive cell characterisation programmes covering identity (STR profiling, karyotyping), safety (adventitious agents, LIVCA/RT assay, HERV screening, mycoplasma), and stability (population doubling, phenotype).
• Interpret characterisation data in the context of regulatory requirements (ICH Q5A, Q5B, Q5D, Q6B) and support preparation of regulatory documentation.
• Maintain up-to-date knowledge of regulatory guidance from FDA, EMA, and PMDA relevant to novel cell substrates.

Scientific Leadership & Collaboration

• Act as the internal subject matter expert on cell line creation, providing scientific guidance to project teams, QA, and clients as needed.
• Mentor junior scientists in cell culture techniques, experimental design, and GMP documentation practices.
• Support proposal development and technical scoping for new client engagements involving cell line creation services.
• Author and review SOPs, technical reports, development reports, and regulatory module contributions.
• Collaborate with Process Development, Manufacturing and Quality Assurance/Regulatory teams to ensure successful progression of cell line creation projects from development through technology transfer.
• Coordinate activities with external testing laboratories and service providers to support cell characterization and release testing.
• Contribute to continuous improvement initiatives, platform technology development, and operational excellence within the Cell Line Creation team.
• Undertake other duties and responsibilities as assigned, based on project and business needs.
• Master or PhD in Cell Biology, Molecular Biology, Biochemistry, or a related discipline, with at least 5 years of post-doctoral or industry experience in cell line development.
• Demonstrated expertise in human cell immortalization, including practical experience with hTERT-based strategies and single-cell cloning workflows.
• Hands‑on experience establishing GMP-compliant MCB/WCB, including associated documentation and release testing.
• Strong working knowledge of ICH guidelines relevant to cell substrates: Q5A, Q5B, Q5D, and Q6B.
• Experience working with primary human cell types or complex cell substrates that present challenges for standard immortalization and banking workflows.
• Proficiency with non-viral transfection and electroporation platforms, and/or viral vector-based gene delivery systems.
• Ability to design, interpret, and document complex experimental programmes with rigorous scientific reasoning.
• Advanced proficiency in Excel (complex formulas, data linking) and the ability to interpret experimental trends to propose logical next steps.
• Strong organizational skills and the ability to learn new techniques and manage multiple tasks simultaneously.
• Excellent communication (oral and written) and presentation skills, with the ability to effectively explain experimental results to internal stakeholders and clients.
• Ability to work well independently and in a team.
• Strong interpersonal skills and a collaborative mindset.
• Strict attention to detail and a commitment to complying with company policies, site safety requirements and applicable regulations.

Preferred Requirements

• Familiarity with cell fate conversion or reprogramming technologies involving small molecules or defined transcription factor combinations.
• Experience in a GMP CDMO or CMO environment.
• Knowledge of EV biology and upstream EV production from continuous cell lines.
• Exposure to regulatory submissions (IND, CTA, or equivalent) involving novel cell substrates.
• Understanding of PMDA regulatory requirements for cell-based therapeutic products.
• Experience coordinating with external testing laboratories for compendial safety testing.