THE OPPORTUNITY

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.
Esco Aster.
One World Biosolutions for One Health.

PHYSICAL/MENTAL REQUIREMENTS/WORK ENVIRONMENT

• Excellent leadership and team collaboration skills with strong communication and negotiation skills.
• Ability to define problems, collect data, establish facts and draw conclusions.
• Ability to focus regardless of circumstances and stress induced pressure.
• Ability to take proactive approach.
• Ability to adapt for improvement and keep up to date on most current regulatory, local and international requirements and guidelines.
• Able to be curious and self-motivated to keep up to date with cell- gene- therapy and future nucleic acid therapeutics as well as other emerging modalities.
• Meticulous and systematic.
• Have strong focus on safety, quality and timeliness.
• Have strong critical thinking skills.

REQUIREMENTS

• Minimum Bachelor’s Degree in Chemical Engineering, Pharmaceutical Science or relevant discipline with 2 years or more experience in a cGMP/aseptic environment in cell and gene therapy.
• Minimum of 2 years in cGMP cell and gene therapy manufacturing with relevant industry knowledge, hands on equipment experience and technical expertise.
• Proven track record in regulatory strategy and interactions.
• Strong knowledge of cGMP practices and global regulatory requirements.
• Experience in bringing cell and gene therapy products through clinical development to market.
• 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.
  Apply now by submitting a Cover Letter and CV to jobs@escoaster.com

• Lead cross-functional biotechnicians function as a bridge between development sciences (contract research and development scientists) to cGMP cell processing facility from Drug Substance to Drug Product.
• Cultivate an atmosphere of continuous improvement, error prevention and quality standard including CAPA/RCA.
• Drive the overall success of infrastructure build and operations for cell and gene therapy programs.
• Collaborate across different unit operations to troubleshoot, test, and optimize various cell processing.
• Work seamlessly in a cross-functional environment.
• Collaborate with commercial teams to ensure launch readiness and market access.
• Serve as Subject Matter Expert during audits and due diligence activities.
• Support sales, business development, product specialists, and associated departments as Subject Matter Expert.
• Modify or improve procedures as necessary to optimize departmental workflows.
• Work with Quality Department and Aseptic Contamination Contral Strategy Ops to manage risk mitigation strategies.
• Author, review and edit relevant documents, including SOPs, Risk Assessments and Technology Transfer Protocols, Electronic Batch Records and other cGMP documents via GDP as needed.
• Conduct periodic technical reviews of Master Match Records (MBRs), including completed MBRs.
• Maintain a focus on customer and/or patient needs to facilitate technology transfer and batch execution.
• Take ownership and accountability for all deliverables and milestones in assigned projects.
• Summarize project work in a formal report and communicate effectively to stakeholders.
• Undertake other tasks as assigned based on project needs.

As Esco Aster is a single use multi product multi-modality cell processing facility CRDMO, the job scope will comprise of the following phases:

• Internal Technology Transfer In: From Internal CRD or External SMEs to cGMP
• Routine Cell Processing: In cGMP
• External Technology Transfer Out: from cGMP to External