Total 15 job vacancies by SG02 Lonza Biologics Tuas Pte.Ltd.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network. 

As a Technologist you will be joining Cell Culture Development team within the Development Services in Lonza Singapore. This group is responsible for the development and characterization of manufacturing processes used for the production of novel therapeutic recombinant proteins for Lonza’s global client base. The purpose of this role is to execute process development and process characterization activities (BLA studies). 

The successful applicant for this position will be joining Cell Culture Development team in Lonza Singapore. This group is responsible for the development and characterization of manufacturing processes used for the production of novel therapeutic recombinant proteins for Lonza’s global client base. The purpose of this role is to support our scientists in process development and characterization activities at laboratory scale. 

Duties and Responsibilities include: 

• To work to the highest scientific standards to support our scientists and projects

• To perform hands-on laboratory work in the mammalian cell culture process development team contributing to the development of processes. For example,

• Perform routine cell culture activities in multi-well plates, deep-well plate and shake flasks.

• Assist in cell line generation activities including transfection and cloning (using Beacon® Optofluidic System)

• Assist in the operation of automated miniature bioreactor systems (Ambr15 or Ambr250), rocking bioreactors and 10L laboratory scale bioreactors. Perform daily culture performance monitoring and analysis using pH meter, osmometer, Nova Flex 2, Vi-Cell

• Prepare media and buffers.

• Capture process data, review and report these data to internal teams.

• Perform activities in accordance with Standard Operating Procedures (SOPs) and study protocols.

• Support daily operation and running of the laboratory, e.g. maintaining of equipment and management of inventory.

• Perform regular housekeeping and help with maintaining 6S standards in the workplace.

• Actively identify and deliver operational efficiency projects to improve efficient running of the department. 

• Contribute to departmental safety and training programs.

• The role may require occasional weekend work. 

Education and Experience:

• Diploma/Bachelor in a relevant Science field or Equivalent. 

• The final role offered will be commensurate with the candidate’s experience. 

• Understand basic theories for mammalian cell culture and bioprocessing. Ability to apply these theories during laboratory operations. Practical laboratory experience in automated bioreactor system operation is highly advantageous. 

• Understanding of cGMP regulations will be advantageous. 

• Good communication skills (verbal and written). 

• Ability to work well in teams. 

• Demonstrates ability to motivate through enthusiasm.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. 

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. 

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The successful applicant for this position will be joining Cell Culture Development team in Lonza Singapore. This group is responsible for the development and characterization of manufacturing processes used for the production of novel therapeutic recombinant proteins for Lonza’s global client base. The purpose of this role is to support lead scientist in process development and characterization activities (BLA studies) and to provide technical expertise to support troubleshooting activities at both laboratory and manufacturing scale.    

Key responsibilities:  

Key requirements:  

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

As a Regulatory Specialist you will be assist the line managers of Lonza Biologics and Lonza Bio Science in all RA support Services and also assist in assessment of deviation and change control activities.

Key Responsibilities:

• Lead and provide regulatory support under the supervision of Line Manager for clinical trial and product license applications in line with major services agreement (MSA) or statement of work (SOW) including but not limited to the preparation of regulatory filings.

• Provide administrative support for all necessary maintenance of certificates, licenses and drug master file(s) (DMF(s))

• Maintain RA owned standard operating procedures (SOP) in line with the good manufacturing practice (GMP)

• Perform regulatory assessment and impact of change control activities.

• Provide regulatory support to project teams.

• Participate in cross functional team to ensure regulatory documentation meets defined timelines and requirements.

• Work in liaison with regulatory colleagues within the Lonza network to support customers clinical trial and product license application to support multi-site products.

• Any other duties as assigned by Line Manager

Key Requirements:

• Degree in Life Sciences in Chemistry / Biology / Biochemistry / Pharmacy or equivalent with 2-5 years of Industry knowledge.

• Knowledge of US, EU and major international regulatory requirements (e.g WHO, ICH) for biologicals

• Good communication and interpersonal skills

• Ability to work with cross functional teams and work under tight timelines.

• Enthusiastic and self-driven

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility in one of 6 areas: Quality Systems, QA Engineering, External QA, QA Excellence (Transformation and Technical Compliance), Quality Operations or Audit Management.

Key responsibilities:

• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility.

• Display a good level of problem-solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience.

• Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections.

• Take on role of QA Specialist in Quality Operations.

• In depth awareness of entire process, identifying operational factors which influence the process.

• Review and approve change controls.

• Review and approve Master Batch Records (MBR), SOPs, protocols, reports or records.

• Support changeover activities.

• Support Annual Product Quality Review activities.

• Can trouble-shoot and able to weigh up all information and consideration in order to choose the optimum path to be taken.

• Demonstrate ability to lead a small project and manage the deliverables effectively.

• Develop good working relationships with internal & external customers.

• Able to participate actively or lead in investigations, change controls, CAPA plans and closure of discrepancy reports.

• Develop skills as an internal GxP auditor, as required.

• Provide support in regulatory inspections and customer audits as required.

• Plan for future activities and coordinate with other departments to complete this.

• Develop skills to be Qualified Trainer in area of expertise.

• Any other tasks as and when assigned by supervisor.

Key requirements:

• Bachelor's degree with exposure in the Biopharmaceutical industry.

• Relevant experience from the Biopharma or any related environment.

• Hands-on experience coordinating & interacting with internal departments on manufacturing activities.

• Knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.

• Meticulous and Systematic.

• Team player, with strong focus on safety, quality and timelines.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

We provide company transport, both ways, at multiple pick up points.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The QC Analyst you will be responsible to conduct test and scheduling/ coordinating of testing with other departments to ensure timely delivery of results. This role is also required to perform peer review of laboratory data, support OOS and Deviation investigations.

Key responsibilities:

• To prioritize and perform the various testing/analysis in timely manner, in order to support the business requirements.  

• Analysis of final    product, in-process, raw material or environmental samples according to Standard Operating Procedures and Test Methods.

• Documentation and review of results in accordance with current Good Manufacturing Practices (cGMP).

• General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.  

• Support sample logistics area including retention sample storage, external lab test, QC documents control, shipment of QC samples.

• Prepare, maintain standards and reagents required by GMP documents.

• Responsible to follow data integrity requirements.

• Actively contributes to operational efficiency/continuous improvement initiatives.

• Problem solving of analytical methods as well as troubleshooting of equipment.

• Involved in equipment qualification, maintenance and troubleshooting.

• Support / Perform OOS, deviation investigations. Draft investigations reports.

• Be a trainer for test method.

• Involvement in method transfers and validation.

• Author Change Controls, Test Methods, SOPs.

• Lead Out -Of - Specifications (OOS) and deviation investigations.

• Any other duties as assigned by your manager. 

Key requirements:

• Degree/Diploma in a relevant Chemistry, Science field or Equivalent.

• Relevant work experience preferably with Lab experience in a biotech or medically related field.

• Relevant experience and accomplishment to dictate final position for which the candidate may qualify.

• Good understanding of HPLC and Empower software.

• Understanding and execution of compendial monographs and the chemistry fundamentals behind methods. Technology/equipment may SDS-PAGE, UV, Infrared Spectroscopy, Nutrient analysis, Osmolality, HPLC, pH, Conductivity, Polarimetry, Refractometry, Density meter Titration (manual and automatic), as well as all compendial testing listed in the USP, JP and EP monographs.

• Provide support in HPLC equipment maintenance and qualification.

• Well versed in cGMP regulations.

• Good problem solving and analytical skills and a team player.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The QC Analyst will act as a team member of the Quality Control department who will participate in quality testing and provide on-time, high quality results to meet Manufacturing demands. The role applies job skills and company's policies and procedures to complete a variety of tasks. The role will encompass a good understanding and execution of intermediate and advanced microbiology techniques (bioburden, LAL, plating and counting techniques, microbial identification, EM tests i.e. air sampling, surface viable sampling, total particulate sampling etc.). Collecting environmental monitoring samples from different areas of the facilities, generation of required trending and reporting information. Assist in process and/ or environmental microbiology related investigations as required.

Key responsibilities:

• To prioritize and perform the various testing/analysis in timely manner, in order to support the business requirements.

• Analysis of bulk product, in-process, raw material or environmental samples according to Standard Operating Procedures and Test Methods.

• Documentation of results in accordance with current Good Manufacturing Practices (cGMP).

• Problem solving of analytical methods as well as troubleshooting of equipment.

• Involvement in method transfers and validation.

• Involved in equipment qualification and technical selection of QC equipment and/or standards and reagents.

• Assay trend analysis, document revision and update.

• General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.

• Any other duties as assigned by your Supervisor/Manager.

Key requirements:

• Degree/Diploma in a relevant Chemistry, Science field or Equivalent.

• Relevant experience and accomplishment to dictate final position for which the candidate may qualify.

• Well versed in cGMP regulations.

• Knowledge of area specific responsibilities.

• Good problem solving and analytical skills.

• Good communication skills.

• A key team player.

 Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieve ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The Material Specialist is responsible for quality documentation in support of  direct material related tasks workflow. These include deviation management, material qualification, raw material specification and change control procedures.

Key responsibilities:

• Responsible for the creation / revision of Raw Material Specification
• Own TrackWise records for complex Change Request, Deviation and applicable Task.
• Provide appropriate coaching and guidance on the execution of Change Request and Deviation as necessary.
• Provide oversight of the timely execution and closure of records related to Supplier Change Notification (SCN), Change Request (CR) and Task. Escalate to Management for records that run into risk of missed timelines.
• Responsible for communicating with customers for notifications and approvals.
• Responsible for workflow and process streamlining and improvement.
• Perform any other tasks as assigned by area management.

Key Requirements:

• Degree or Diploma in SCM or Quality relevant discipline.
• Solid Material management experience in GMP environment.
• Planning, organizing and controlling skills and action oriented.
• A team player with Positive attitude.
• Sensitive to deadlines.
• Good communication and time management skills.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

As a senior process engineer you will lead the timely and successful transfer of the cell culture or purification stages of the customer’s manufacturing process(es) into the Lonza Singapore production facility. Lead the preparation, execution, process monitoring and post-campaign activities for cell culture or purification stages of the customer’s manufacturing processes at Lonza Singapore production facility and also lead investigations into process trends, issues or deviations.

Key responsibilities:

• Technology Transfer: Lead the timely and successful transfer of the cell culture or purification stages of the customer’s manufacturing process(es) into the Lonza Singapore production facility. Work with other MSAT team members, technical experts from Lonza’s customer companies or Lonza donor sites, Manufacturing (MFG), Quality Assurance (QA), Quality Control (QC), and other departments on the technology transfer.

• Process Support: Lead the preparation, execution, process monitoring and post-campaign activities for cell culture or purification stages of the customer’s manufacturing processes at Lonza Singapore production facility. Become proficient with all processes in the facility and develop ability to support/lead activities across multiple processes. Monitor processes on a regular basis to have further understanding of process behavior and prospectively identify process issues. Develop ability to generalize issues across processes.

• Write change requests and drive to implementation as needed.

• Review cell culture or purification process manufacturing batch records and provide technical input to MFG technical document writing specialists.

• Identify training needs and provide training materials for MFG operators on cell culture or purification process batch records. Work with MFG to update process batch records to enable robust manufacturing operations.

• Support plant start-up and pilot/commercial runs and perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues for cell culture or purification operations.

• Design and perform/ support small-scale experiments/ studies in lab to support technology transfer or investigations.

• Follow all applicable lab safety policies.

• Support preparation of Annual Product Review (APR) and Continued Process Verification (CPV) summary reports, perform work-stages to support customer BLA filing.

• Maintain process databases and monitor batch to batch consistency of operations.

• Support inspections and audits by customer and regulatory authorities.

• Provide technical guidance and share process knowledge to MSAT team members and other departments.

• Any other duties as assigned by your Supervisor/Manager

Key requirements:

• Degree in chemical engineering, biochemical engineering, biochemistry/ chemistry/microbiology or related discipline.

• Extensive work experience in Biotechnology process development, process support, research or a related manufacturing environment.

• Prior hands-on experience in purification experimental technique and equipment.

• Knowledge of Excel as well as Statistical Data Analysis tools.

• Excellent communication skills, outstanding action orientation, and ability to work well in a cross-functional technical environment.

• Excellent technical writing skills, ability to provide attention to detail is essential.

• Demonstrated track record in completing projects under tight timelines.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

We have a great opportunity for Biotechnologist to join our Manufacturing Central Operations group at our Tuas site in Singapore. Reporting to the Section Lead/Manager, you will be responsible for the manufacturing of therapeutic proteins under cGMP conditions.

You will be working in 12-hour rotating shift in a 2-2 3-2 2-3 pattern and will be compensated with shift premium and allowances!

Key responsibilities:

• Learn and perform well-defined procedures within a GMP manufacturing setting
• Perform equipment monitoring & and basic 6S housekeeping
• Perform basic laboratory tasks (e.g. sampling, pH/ conductivity/ osmolality measurements etc.)
• Perform routine sanitization tasks to maintain facility standards
• Trained & signed off on Performance Measures (PMs) relating to CIP/ SIP/ basic tank & instrument operations
• Demonstrate aseptic technique in the handling of product/ materials
• Perform basic process & equipment troubleshooting
• Multi-task on equipment preparations & operations to ensure adherence to schedule
• Attain full competency in the performance of all operations relevant to manufacturing areas assigned.
• Display basic process & equipment troubleshooting ability under routine scenarios.
• Become a technical process expert by exhibiting basic understanding of critical process/operational parameters and target/acceptable ranges, as well as interactions between different process parameters.
• Use Standard Operating Procedures (SOPs), logbooks & Batch Records (BRs) effectively & competently
• Submit samples via Laboratory Information Management System (LIMS)

Materials & Equipment Preparations

• Able to identify the correct materials by part number and FEFO lots.
• Select appropriate Dispensing Booths/Hoods and Weight balance.
• Identify sampling requirements based on material RMS.
• Assemble Autoclave assembly per SOP.
• Able to perform equipment wash without stains and residues.

Solutions Preparations

• Enhanced knowledge of the different setup and equipment use between customers for different operations, e.g.: CIPs and buffer/media transfer
• Able to identify and lead the installation of the different set up and equipment for different customers for different operations, e.g.: CIPs and buffer/media transfer
• Understand the criticality of setting up the right path and equipment for different customers
• In depth knowledge of the different set up and the equipment use between single use and the conventional stainless steel equipment
• Able to formulate plans for executing CIPs to meet different customers requirement, e.g., the CIPs of the HTST.

Key requirements:

• Diploma/NITEC in a related Science/Engineering discipline or some relevant work experience in a similar industry
• Knowledge of Biopharmaceutical processing is not essential, but an added asset
• Knowledge of cGMP applications
• Positive team oriented attitude
• Strong communication and interpersonal skills
• Willing to perform rotating 12-hour shift pattern

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

Key Responsibilities:

• Point of contact in the department for laboratory support and inventory matters
• Performs laboratory support services assisting the dept in running an efficient laboratory.  Includes but not limited to housekeeping, preparing buffers, media, routine calibration of equipment and maintaining inventory levels by working closely with delivery and stores personnel.
• Has an area of expertise in the lab and a good understanding of a subset of equipment.  Able to apply expertise and perform standard laboratory activities such morning verifications, equipment data and time check etc
• Drives and implements improvement activities using laboratory expertise and OE concepts
• Equipment owner and trainer for equipment or lab activities
• Liaise with other Lonza departments and vendors for inventory and equipment matters
• Point of contact in the department for equipment calibration, preventive maintenances, etc
• Perform equipment validation and qualification, equipment requalification, equipment maintenance and troubleshooting etc
• Perform Equipment Validation Maintenance Quality Systems review and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state
• Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements
• Perform assigned Quality Systems activities including: Document Management System (DMS), and Track Wise system (Change Control, Deviations, CAPA, etc)
• Any other duties as assigned by Management

Key Requirements:

• Experience and understanding of laboratory equipment and associated quality systems

• Understanding of cGMP regulations

• Strong technical writing skills and ability to document all work in a meticulous, accurate, and timely manner

• Strong written, oral communication skills and ability to work interdepartmentally with very minimal supervision in an effective manner to carry out daily duties

• Understand how to write discrepancies, give a root cause analysis and perform Quality Risk Assessments

• Strong organizational and time management skills

• Excellent communication skills

• Excellent teamworking skills

• Demonstrates ability to prioritize tasks as needed to support the changing business demands

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

We have a number of great opportunities for Biotechnologists to join our Manufacturing Team at our Tuas site in Singapore. Reporting to the Section Lead/Manager, you will be responsible for the manufacturing of therapeutic proteins under cGMP conditions.

You will be working in 12-hour rotating shift in a 2-2 3-2 2-3 pattern and will be compensated with shift premium and allowances!

Key responsibilities:

• Learn and perform well-defined procedures within a GMP manufacturing setting
• Perform equipment monitoring & and basic 6S housekeeping
• Perform basic laboratory tasks (e.g. sampling, pH/ conductivity/ osmolality measurements etc.)
• Perform routine sanitization tasks to maintain facility standards
• Trained & signed off on Performance Measures (PMs) relating to CIP/ SIP/ basic tank & instrument operations
• Demonstrate aseptic technique in the handling of product/ materials
• Perform basic process & equipment troubleshooting
• Multi-task on equipment preparations & operations to ensure adherence to schedule
• Attain full competency in the performance of all operations relevant to manufacturing areas assigned.
• Display basic process & equipment troubleshooting ability under routine scenarios.
• Become a technical process expert by exhibiting basic understanding of critical process/operational parameters and target/acceptable ranges, as well as interactions between different process parameters.
• Use Standard Operating Procedures (SOPs), logbooks & Batch Records (BRs) effectively & competently
• Submit samples via Laboratory Information Management System (LIMS)

Cell Culture (Upstream large scale)

• Skill and knowledge of aseptic technique for subculture stages example using culture flask, spinners, wave bioreactors, etc.
• Technical knowledge on the bioreactor culture control example pH/DO control, CO2/O2 control, cell performance, and metabolites analysis.

Purification (Downstream large scale)

• Skill and knowledge of column chromatography techniques, tangential flow filtration techniques, micro/Nano filtration techniques, pH/Conductivity adjustment techniques, aseptic techniques.
• Technical knowledge on the chromatography operating interface example using UNICORN software and various DeltaV control parameters for chromatography and UF operation.
• Knowledge in single use applications for the respective processes.

Key requirements:

• Degree/Diploma in a related Science/Engineering discipline
• Some relevant work experience in a similar manufacturing industry or cleanroom environment
• Knowledge of Biopharmaceutical processing is an added asset
• Knowledge of cGMP applications
• Positive team oriented attitude
• Strong communication and interpersonal skills
• Willing to perform rotating 12-hour shift pattern

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

Key responsibilities:

• Provide expertise and ownership to the range of computerized systems used in the laboratory.

• GMP Computer Systems Administration (e.g. Empower, Softmax Pro, Electronic Lab Notebook) including system back-up, audit trail review, user access administration.

• GMP Computer Systems Validation – support the implementation and validation of new systems to be used for cGMP analytical activities including the writing and review of validation protocols and reports. This responsibility includes periodic revalidation of the equipment.

• Strategic deployment of software upgrades including training of end users as required.

• Develop expertise to be able to represent the department during audits by customers and regulatory bodies.

• Understanding and management for all other laboratory systems controlling operational technology in the department for example in the area of upstream process development.

• Support the end users in day-to-day operation of software/systems and able to identify computer related issues; troubleshoot, identify and complete or coordinate deviation, change control and/ or corrective action records as well as via liaison with vendors.

• Maintain an understanding of new technology and their application to the department.

• Collaboration with end users within the department to enable their efficient use of the laboratory systems.

• Collaborate with departments in Singapore and across the global Lonza network (e.g. QC/IT/QA/Development).

Key requirements:

• Degree/Diploma in a relevant Science field or Equivalent

• Relevant work experience preferably with laboratory related IT experience in a biotechnology or related medical field.

• Expertise in computer systems controlling laboratory equipment (e.g. Empower).

• Exposure to cGMP and experience in computer system validation.

• Familiarity with 21 CFR Part 11 and EU Annex 11 requirements, data integrity requirements and expectations as well as common industry practice with respect to laboratory computerized system management and administration.

• Exposure to basic programming concepts and databases.

• Excellent problem solving and analytical skills and experience working within a formal Quality Management System (cGxP/ISO)

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

The Senior QA Specialist will lead and support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for multi-product s and also provides QA support for Audit Management.

Responsibilities:

• Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, and GMP biotech contract manufacturing facility.

• Highly motivated individual and have superior skills in all areas relevant to the job.

• Member of cross-functional site team(s) on projects/ issues.

• Lead in complex deviation investigations, change controls, CAPA proposals and closure of discrepancy reports.

• Superior ability to troubleshoot.

• A competent Reviewer and Approver of SOPs, protocols, reports or records.

• Able to coordinate between departments for multiple parallel activities.

• Understanding of advanced topics pertaining to cGMP.

• Participate in Customer / Agency Audits and Inspections as required.

• Identify process pathways and work to develop improvements in strategy.

• Help/Transfer and quickly assimilate to leadership role in other process areas.

• Assume Supervisory responsibility in absence of supervisor

• Understands and articulates company business strategy. Maintains a broad view of the

  business, recognize changes and trends in the appropriate area in which the individual

  operates.

• Any other tasks as and when assigned by supervisor.

Requirements:

• Engineering/Science Degree or higher from recognized institution with 5 to 10 years’ experience in Validation / Quality unit in the Biopharmaceutical industry

• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).

• Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility 

• Good interpersonal skills

• Effective Communicator (oral and written)

• Exhibit good quality decision making traits

• Meticulous, Systematic and Analytical Mind

• Team player who can operate independently, with strong focus on safety, quality and timelines.