Cell Line Creation Scientist
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About the role
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. Who we're looking for Physical/Mental Requirements/Work Environment Ability to read, analyse and interpret scientific data and publications. Ability to author or review protocols, technical reports and technology transfer documents. Ability to author or review standard operating procedures and other related documents. Ability to define problems, collect data, establish facts, and draw conclusions. Ability to focus. 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. Good understanding of cGMP and GDP requirement and practices. Able to don in the cleanroom gowning and understand Aseptic Behaviour requirements. 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. Primary Work Location: Ayer Rajah Crescent, Singapore 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 Q5Dand applicable GMP guidelines. - Define pre-cloning pool testing strategies and MCB characterisation plans with appropriate risk-based justification, in alignment with ICH Q5A and Q5Brequirements. - 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 P
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