Cell Therapy Senior Biotechnologist / Senior Manufacturing Associate

Esco Aster; Singapore; On-site; SGD 70,000 - 100,000; Full time

Benefits offered by this job

Learning and Development opportunities

Competitive Compensation

Overseas Travel Opportunities

Job summary

A leading life sciences organization in Singapore is seeking a candidate with expertise in cGMP cell and gene therapy manufacturing. The role involves overseeing cell processing and collaborating across departments to ensure successful project delivery. Candidates should have a Bachelor's degree and a minimum of 4 years of experience in a relevant field. This position offers an opportunity to contribute to innovative research and make a significant impact in life sciences.

Qualifications

• Minimum of 4 years of experience in a cGMP environment.
• Experience in bringing products through clinical development to market.
• Strong interpersonal skills and ability to work independently.

Responsibilities

• Lead cross-functional biotechnology teams to ensure successful cell processing.
• Collaborate across various departments for optimal cell processing.
• Conduct technical reviews of Master Batch Records.

Skills

Ability to read and interpret scientific data

Ability to author or review technical reports

Strong knowledge of cGMP practices

Experience in cell and gene therapy manufacturing

Proficient in MS Office Suite

Education

Bachelor's Degree in Chemical Engineering or relevant discipline

Job description

Join us for the world we are making, redefining biosolutions for current and future generations to come, transcending planetary boundaries, sustainability, and One Health.

Growth

Weempower each other to produce better resultsby providingprofessional advancement and personalgrowth.

Weare driven by the challenge of creating something new and discovering better opportunities.

We value a positive attitude. We make working a more pleasant experience for everyone.

Communication

We value communication, for it creates better intercultural relationships.

Competence

We focus onthings that matter mostand help each otherdrive success.

Commitment

We see the good. We work hard. We keep things in balance.

Growth

Weempower each other to produce better resultsby providingprofessional advancement and personalgrowth.

Weare driven by the challenge of creating something new and discovering better opportunities.

We value a positive attitude. We make working a more pleasant experience for everyone.

Communication

We value communication, for it creates better intercultural relationships.

Competence

We focus onthings that matter mostand help each otherdrive success.

We want ourworkforceto become a happier, healthier, more productive place to work.

BENEFITS

Learning and Development

Competitive Compensation

Overseas Travel Opportunities for many positions

One Team, One Mission

Are you a seasoned professional looking for your next challenge? Be one of us!

The Opportunity

Esco Lifesciences Group is Singapore’s most globalizedlife sciences company, with annual revenues close to SGD 200M and globaloperations in over 42 locations and 26 direct countries across North America,Europe, Asia, Oceania.

Esco Aster Pte Ltd is an affiliate of EscoLifesciences Group and was first incorporated in 2017.

Esco Aster is a contract research development andmanufacturing organization founded and deeply rooted by scientists enablingfellow scientists to translate their bench work into commercially availableproducts at affordable prices.

Our scientific work is in emerging and frontierbiology utilizing cells as a final product or deriving products from cellswhich often we use cells as the factory to derive our target product.

Our first commercial breakthrough success is EscoAster is commercially first in class being first in the world to be certifiedfor cultivated/cell-based meat to FSSC 22000 and by a competent food regulatorybody.

We are first in the region to operate an end-to-endintegrated full cell line creation/immortalization or engineered cell line,cell culture process development, analytical development for stem cells andexosomes 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 impacton our world. We offer you an opportunity to be part of this exciting journeyto own your career and firsthand exposure to new emerging modalities supportingtranslational sciences.

Join us as we redefine BioSolutions for One World andOne 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 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

The Scope

You will be part of Esco Aster’scGMP Technology Transfer Cell Manufacturing (TTCM) Unit contribute towards theoverall site mission and objectives for culturing of cells and derivatives fromcells.

You will work with internal andexternal stakeholders to maintain customer’s processes in the company’s cGMPfacility.

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

This role will ensure thesuccessful advancement of our therapeutic pipeline from early developmentthrough technology transfer for clinical trial material manufacturing andeventual technology transfer out and/or commercialization, focusing onregulatory compliance, manufacturing excellence and market readiness.

Primary work location: AyerRajah Crescent, Singapore

Report To:

Selected candidate will report to CEO and others as assigned.

Job Responsibilities

• Lead cross-functional biotechniciansfunction as a bridge between development sciences (contract research anddevelopment scientists) to cGMP cell processing facility from Drug Substance toDrug Product.
• Cultivate an atmosphere ofcontinuous improvement, error prevention and quality standard includingCAPA/RCA.
• Drive the overall success ofinfrastructure build and operations for cell and gene therapy programs.
• Collaborate across different unitoperations to troubleshoot, test, and optimize various cell processing.
• Work seamlessly in across-functional environment.
• Collaborate with commercialteams to ensure launch readiness and market access.
• Serve as Subject Matter Expertduring audits and due diligence activities.
• Support sales, businessdevelopment, product specialists, and associated departments as Subject Matter Expert.
• Modify or improve procedures asnecessary to optimize departmental workflows.
• Work with Quality Department andAseptic Contamination Contral Strategy Ops to manage risk mitigationstrategies.
• Author, review and edit relevantdocuments, including SOPs, Risk Assessments and Technology Transfer Protocols,Electronic Batch Records and other cGMP documents via GDP as needed.
• Conduct periodic technicalreviews of Master Match Records (MBRs), including completed MBRs.
• Maintain a focus on customer and/orpatient needs to facilitate technology transfer and batch execution.
• Take ownership andaccountability for all deliverables and milestones in assigned projects.
• Summarize project work in aformal report and communicate effectively to stakeholders.
• Undertake other tasks asassigned based on project needs.

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

-Internal Technology TransferIn: From Internal CRD or External SMEs to cGMP

-Routine Cell Processing: IncGMP

-External Technology TransferOut: from cGMP to External

Internal Technology Transfer In

• Work with both internal and external customerSMEs to transfer in and maintain customer’s processes in cell processingfacility.
• Observe and take on a hands-on role with CRDscientists during process consistency runs to ensure successful knowledgetransfer into cGMP.
• Develop material requirements, processexecution and method transfer.
• Carry out Commissioning & Qualification(C&Q) activities of new process equipment and/or systems as identified forboth functional as well as automation software and overall trainingqualifications of new biotechnicians.
• Support any investigation for deviationsidentifying root causes and implementing preventive actions and changes duringthe C&Q phase if required.
• Ensure Digital Readiness and qualification byworking with electronic batch record department for eBatch records using Tulipwith process engineers/experts.
• Perform Process Performance Qualification (PPQ),Aseptic Process Simulation runs, particle runs, training runs, water runs, pilotas well as engineering runs within cGMP environment before actual manufacturingwith cross functional teams for the digital systems related to cell processingequipment and overall cGMP workflow.
• Work on Gas Cycle Development and LineClearance Procedures with validation department.
• Collaborate with MSAT, QA and QC Departmentsto map out processes according to risk assessment and process flow diagrams perISO for new processes.
• Collaborate with SMEs and Leadership team todetermine equipment and materials for cell processing suite that will need topurchase per campaign to run cell processes.
• Author and review cGMP documents ranging fromwork instructions, SOPs, TQM etc.) for equipment and cell processing.

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

• Work with supply chainmanagement to ensure readiness and raw materials are just in time and onschedule per chain of custody and chain of identity.
• Set up and perform cGMP cell manufacturingprocedures and cell processing as an Operator and/or Verifier in a cGMP/asepticenvironment to produceclinical/commercial material that is compliant with cGMP requirements as wellas In-Process Monitoring, In Process Sampling.

Cell processing will involve being familiarwith the following (OJT will be provided as need):

Cell Culture Upstream Small Scale

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

Purification (Midstream, Downstream Small Scale)

• Cell washing using cell washing devices,centrifugation or membrane-based technologies (spin filters /TFF) equivalent orchromatography.
• 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-usepost 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 dryingoperations.
• Visual Inspection, controlled rate freezingand secondary packaging.
• Ensure cGMP requirementscompliance and other regulatory standards.
• Support investigationsrelated to manufacturing processes.
• Support the clinical andcommercial material as required
• Potentially lead a smallteam.

Requirements

• Minimum Bachelor’s Degree inChemical Engineering, Pharmaceutical Science or relevant discipline with 4years or more experience in a cGMP/aseptic environment in cell and genetherapy.
• Minimum of 4 years in cGMP celland gene therapy manufacturing with relevant industry knowledge, hands onequipment experience and technical expertise.
• Proven track record inregulatory strategy and interactions.
• Strong knowledge of cGMPpractices and global regulatory requirements.
• Experience in bringing cell andgene therapy products through clinical development to market.
• In-depth knowledge of the drugdevelopment process and commercialization pathways.
• Proficientin MS Office Suite (Microsoft Word, PowerPoint, Excel).
• Able towork independently and task oriented in a dynamic environment.
• Strongteam player with a strong set of interpersonal skills.