55 Manufacturing Associate jobs in Singapore

Votre profil
Créée en 2007, Antaes est une société suisse de conseil en management et technologie classée dans le top 15 des sociétés de conseil en Suisse. Nous comptons plus de 300 ingénieurs expérimentés qui partagent notre passion.
Présents en Suisse, à Singapour, à Hong-Kong et en France, nous accompagnons nos clients suisses et internationaux en intervenant dans les domaines suivants :
Conseil en organisation et transformation
Ingénierie Industrielle
Management des systèmes d'Information
En rejoignant nos équipes vous découvrirez :
Une équipe dynamique dans un esprit start-up
Un accompagnement humain et un suivi de l’évolution de votre carrière
Des challenges pour contribuer au développement de votre réseau
Des événements : team building, meet-up, workshop, Winter Event .
Une entreprise certifiée @HappyAtWork et ayant une politique RSE engagée (médaille d’or Ecovadis2023).
Chargé de Formation Outils Bureautiques 80-100% H/F
Ingénierie Industrielle et Life-Science
Nous recrutons en CDI Chargé de Formation Outils Bureautiques à 80% voir 100% afin de rejoindre notre pôle d'expertise dans le cadre d'un projet de grande envergure et longue durée, d'extension des activités de notre partenaire à Bienne.
En tant que Chargé de Formation Outils Bureautiques H/F vos missions seront :
Répondre aux besoins de Formation Continue en matière d'Outils Bureautiques et Collaboratifs pour favoriser le développement des compétences et contribuer aux enjeux de l'entreprise.
Piloter le nombre de demandes de formation dans les objectifs fixés.
Identifier et analyser les besoins de formations clients.
Mener des entretiens conseils après des clients.
Collaborer à l'organisation des formations avec les équipes.
Nous recrutons en CDI un Métrologue Industriel F/H
afin de rejoindre notre pôle d'expertise, dans le cadre d'un projet de grande envergure et de longue durée d'extension des activités industrielles de notre partenaire.
En tant que Métrologue Industriel F/H, vos missions seront :
Créer et mettre au point les gammes et programmes de contrôle, gérer la documentation technique associée.
Programmation de machine à mesurer tridimensionnelle.
Assurer le soutien technique auprès des équipes d'exploitation.
Formaliser les analyses et communiquer vers les partenaires.
Identifier les critères de mesure, les équipements nécessaires et les normes à suivre pour assurer la précision et la qualité des contrôles.
Travailler en étroite collaboration avec les équipes de production, d'ingénierie et de contrôle qualité pour assurer la cohérence des normes et des processus.
Chef de Projet Investissement / Maintenance H/F
Suisse - Genève
Ingénierie Industrielle et Life-Science
Nous recrutons en CDI un Chef de Projet Investissement / Maintenance H/F afin de rejoindre notre pôle d'Expertise Industrielle dans le cadre d'un projet de grande envergure et longue durée, d'extension des activités de notre partenaire situé à Genève.
En tant que Chef de Projet Investissement / Maintenance H/F, vos missions seront :
Représenter la Maintenance dans des projets d'acquisition d'équipements dans le domaine de la production.
Formuler les besoins, définir les objectifs, conduire, développer et mettre en place des solutions.
Piloter, coordonner et planifier les projets avec les équipes et les partenaires industriels et les partenaires internes (Achats, IT).
Contrôler le respect des prescriptions Maintenance en relation avec les fournisseurs et les équipes Maintenance Opérationnelle.
Communiquer sur l'avancement des jalons et des livrables en fonction des objectifs définis dans le cadrage.
Faciliter la mise en production des nouveaux équipements.
Assurer la maintenabilité des nouveaux équipements (anticipation problématiques, garantir la vie série en adoptant une approche environnementale).
Avoir la vision globale des investissements en cours et des activités de la maintenance.
Adopter une approche méthodologique projets.
#J-18808-Ljbffr

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

We empower each other to produce better results by providing professional advancement and personal growth.

We are 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.

We value communication, for it creates better intercultural relationships.

We focus on things that matter most and help each other drive success.

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

Learning and Development

Competitive Compensation

Overseas Travel Opportunities for many positions

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

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, and 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.

• 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.

Report To:

Selected candidate will report to CEO and others as assigned.

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

• 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

• 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.

• 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):

• 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.

• 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.

• 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.

• 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.

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

We empower each other to produce better results by providing professional advancement and personal growth.

We are 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 on things that matter most and help each other drive success.

Commitment

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

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!

Cell Therapy Biotechnologist / 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, and 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

• 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.

Report To:

Selected candidate will report to CEO and others as assigned.

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 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.

A food processing worker is responsible for assisting in various stages of food production, including preparation, packaging, and quality control.

The ideal candidate should have a strong understanding of health and safety guidelines and be able to maintain a clean and organized workspace.

Additionally, the successful candidate will be able to monitor production processes and report any issues to supervisors.

Food preparation machines and equipment will also need to be operated by the selected individual.

Ultimately, the goal of this role is to contribute to the success of our organization by providing high-quality products while adhering to strict SOPs and recipes.

Key Responsibilities include:

• Assist in various stages of food production, including preparation, packaging, and quality control
• Follow health and safety guidelines to maintain a clean and organized workspace
• Monitor production processes and report any issues to supervisors
• Operate food preparation machine and equipment
• Follow the food processing SOP and recipe strictly

Requirements include:

• Minimum O-Level/N-Level or equivalent
• Able to carry heavy products when needed (e.g. 10kg - 15kg)
• High standard of personal hygiene

Benefits include working five days a week, from Monday to Friday, with hours ranging from 9am to 6pm.

Our company offers a competitive salary package that includes AWS + Variable Bonus + OT.

Application Instructions:

1. Click the 'Apply Now' button below to submit your application.

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
We empower each other to produce better results by providing professional advancement and personal growth.
We are 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 on things that matter most and help each other drive success.
Commitment
We see the good. We work hard. We keep things in balance.
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!
Cell Therapy Biotechnologist / 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, and 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
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.
Report To:
Selected candidate will report to CEO and others as assigned.
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 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.
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Position for On-Site Line Leader (Flexi Shift). The incumbent must be able to support our flexible operating requirements and business needs.

Will be payable according to the shift worked.

• 2nd shift: 3.00pm to 11.00pm (1 tea break)
• 3rd shift: 11.00pm to 7.00am (1 tea break)
• Normal shift: 7.30am to 5.00pm (2 tea breaks: 15 mins each, and a 30-min lunch/dinner break)

• Annual Leave: 13 days + 2 supplementary days
• Medical & Hospitalization Leave: 60 days (14 days + 46 days)
• Flexible Benefits Program: Insurance, Medical, Dental & Health Screening
• Annual Wage Supplement (AWS): December payout
• Merit Increment: March payout
• Overtime: as per Employment Act guidelines
• In-House Cafeteria: Free Lunch & Dinner
• Work Schedule: 5 days a week, Monday to Friday
• Transport: where applicable

1. Do production planning, assist supervisor in arranging personnel allocation in production department, and participate in production line operations.
2. Ensure production volume is up to standard and machine operation is smooth.
3. Participate in employee training and implement safety standards and instructions.
4. Training will be provided, and active cooperation and willingness to learn are required.
5. Team lead experience in medical factory production lines will be prioritized.

EA Personnel By: LIM SWEE HAN | EA Personnel No: R1547369 | EA License No.: 23C1570

Visi Intergroup Pte. Ltd. | Permanent & Search Division | Private & Confidential

Manage the daily operation of the production line, organize production according to schedule, and monitor production progress.

Include the following. Other duties may be assigned.

• Monitor production safety and discipline; manage 6S of the production area. Support health and safety programs (DWB, BBS, H&S meetings).
• Allocate resources in the production line and ensure compliance with departmental and company regulations. Know how to calculate HC, overtime, and output requirements.
• Schedule production in line with the production plan and monitor progress closely.
• Supervise and train employees following Working Instructions.
• Provide feedback on process issues and ensure product quality.
• Manage materials in the production line, including locating materials at designated stations, labeling, and tracking.
• Ensure all operations follow effective instructions.
• Maintain accurate records, databases, and document management for production line integrity and effectiveness.
• Propose Kaizen suggestions to improve production efficiency.
• Perform daily maintenance of equipment, fixtures, and jigs to promote utilization.
• Handle other assignments as delegated by superiors.
• Ensure line clearance procedures are followed correctly.

Job Summary:

Manage the daily operation of the production line, organize production according to schedule, and monitor production progress.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Monitor production safety and discipline; manage 6S of the production area. Support health and safety programs (DWB, BBS, H&S meetings).
• Allocate resources in the production line and ensure compliance with departmental and company regulations. Know how to calculate HC, overtime, and output requirements.
• Schedule production in line with the production plan and monitor progress closely.
• Supervise and train employees following Working Instructions.
• Provide feedback on process issues and ensure product quality.
• Manage materials in the production line, including locating materials at designated stations, labeling, and tracking.
• Ensure all operations follow effective instructions.
• Maintain accurate records, databases, and document management for production line integrity and effectiveness.
• Propose Kaizen suggestions to improve production efficiency.
• Perform daily maintenance of equipment, fixtures, and jigs to promote utilization.
• Handle other assignments as delegated by superiors.
• Ensure line clearance procedures are followed correctly.

• Set up and operate meal packing lines, maintaining high levels of efficiency and productivity.

• Troubleshoot any issues with the packing line, implementing effective solutions to minimize downtime.

• Maintain and repair kitchen and packing equipment, adhering to strict health and safety standards.

• Ensure the safe operation of equipment, minimizing the risk of accidents and injuries.

• Perform other ad hoc duties as assigned by management.

• A minimum of 2-3 years' experience in food production or a related field.

• A good understanding of food processing and packing equipment, including their maintenance and operation.

• Hands-on skills in mechanical, electronic, and electrical work.

• The ability to work flexible shifts, including evenings and weekends.

• Experience working in a central kitchen environment is highly desirable.

• Knowledge of food safety and hygiene practices is advantageous.

• Maintenance & Repair

• Troubleshooting

• Food Safety

• Inventory Management

• Electrical & Mechanical Skills

• Technical Support