Cell Therapy Senior Biotechnologist / Senior Manufacturing Associate

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.

Who we’re looking for

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.
• Strong focus on safety, quality and timeliness.
• Strong critical thinking skills.

The Scope

You will be part of Esco Aster’s cGMP Technology Transfer Cell Manufacturing (TTCM) Unit contribute towards the overall site mission and objectives for culturing of cells and derivatives from cells.

You will work with internal and external stakeholders to maintain customer’s processes in the company’s cGMP facility.

You will oversee the strategic direction, development and execution of cell and gene therapy programs.

This role will ensure the successful advancement of our therapeutic pipeline from early development through technology transfer for clinical trial material manufacturing and eventual technology transfer out and/or commercialization, focusing on regulatory compliance, manufacturing excellence and market readiness.

Primary work location: Ayer Rajah Crescent, Singapore

Job Responsibilities

• 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 Control 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

Internal Technology Transfer In

• Work with both internal and external customer SMEs to transfer in and maintain customer’s processes in cell processing facility.
• Observe and take on a hands-on role with CRD scientists during process consistency runs to ensure successful knowledge transfer into cGMP.
• Develop material requirements, process execution and method transfer.
• Carry out Commissioning & Qualification (C&Q) activities of new process equipment and/or systems as identified for both functional as well as automation software and overall training qualifications of new biotechnicians.
• Support any investigation for deviations identifying root causes and implementing preventive actions and changes during the C&Q phase if required.
• Ensure Digital Readiness and qualification by working with electronic batch record department for eBatch records using Tulip with process engineers/experts.
• Perform Process Performance Qualification (PPQ), Aseptic Process Simulation runs, particle runs, training runs, water runs, pilot as well as engineering runs within cGMP environment before actual manufacturing with cross functional teams for the digital systems related to cell processing equipment and overall cGMP workflow.
• Work on Gas Cycle Development and Line Clearance Procedures with validation department.
• Collaborate with MSAT, QA and QC Departments to map out processes according to risk assessment and process flow diagrams per ISO for new processes.
• Collaborate with SMEs and Leadership team to determine equipment and materials for cell processing suite that will need to purchase per campaign to run cell processes.
• Author and review cGMP documents ranging from work instructions, SOPs, TQM etc.) for equipment and cell processing.

Campaign Cell Processing (Autologous / Allogeneic) for GLP Tox-CTM-Commercial

• Work with supply chain management to ensure readiness and raw materials are just in time and on schedule per chain of custody and chain of identity.
• Set up and perform cGMP cell manufacturing procedures and cell processing as an Operator and/or Verifier in a cGMP/aseptic environment to produce clinical/commercial material that is compliant with cGMP requirements as well as In-Process Monitoring, In Process Sampling.
• Cell processing will involve being familiar with the following (OJT will be provided as need):

Cell Culture Upstream Small Scale

• Single Use Mixers and Single Use Cell Culture from Culture flasks, Cell factories, G-Rex or equivalent up to 40L single use bioreactors with microcarriers, Tide Motion adherent cell bioreactors, Cell Processing Isolators.

Purification (Midstream, Downstream Small Scale)

• Cell washing using cell washing devices, centrifugation or membrane-based technologies (spin filters /TFF) equivalent or chromatography.
• Loading of payloads into Exosomes or LNPs using incubation, extrusion or other methods.

Fill & Finish (in Isolators or closed systems)

• Bulk drug substance formulation.
• Sterile Filtration including PUPSIT (pre-use post sterilization integrity testing).
• Cell Filling in small scale single use closed automated bench systems from cryovials/screw-tube vials, CryoBags, COC/COP/Glass Vials with Stoppers and Flip-Off Caps including freeze drying operations.
• Visual Inspection, controlled rate freezing and secondary packaging.
• Ensure cGMP requirements compliance and other regulatory standards.
• Support investigations related to manufacturing processes.
• Support the clinical and commercial material as required.
• Potentially lead a small team.

Requirements

• Minimum Bachelor’s Degree in Chemical Engineering, Pharmaceutical Science or relevant discipline with 4 years or more experience in a cGMP/aseptic environment in cell and gene therapy.
• Minimum of 4 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.