Total 33 job vacancies by 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.

This role is responsible for conducting 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 investigation.

Responsibilities

• 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).
• 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 includes housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.
• Assay trend analysis, document version and update.
• Independently lead and conduct OOS, deviation investigations. Draft investigations reports.
• Support in team leadership and driving results to meet department KPIs.
• SME in 1 or more areas as aligned with the training plan.
• Able to make decisions independently on the area of expertise.
• Coach and train junior team members.
• Practice and support audit activities
• Any other duties as assigned by your Supervisor/Manager

Experience

• Degree/Diploma in a relevant Science field or Equivalent.
• Understanding and execution of spectroscopy and other assigned methods which may include chromatography methods (HPLC), ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, TOC , Protein Concentration (A280 or SoloVPE), osmolality, potency methods, appearance and other physiochemical methods.
• Work experience preferably Lab experience in a biotech or medically related field
• Relevant experience and accomplishment to dictate final position for which the candidate may qualify
• Good problem solving and analytical 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.

The QC Analyst 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. Role will also 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.
• Working hours: 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 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 successful applicant for this position will be joining Purification Development team in Development Services, Lonza Singapore. As a Senior Scientist, you will be able to develop and enhance your technical and scientific capabilities as well as build on your technical leadership skills. You will be involved in hands-on experimental activities as well as supporting projects right from planning to delivery.

Duties and Responsibilities include:

• Perform hands-on laboratory work in the purification process development team contributing or leading the development of processes suitable for technology transfer to the cGMP manufacturing teams. An understanding of cGMP manufacturing facility constraints and their impact on development activities will be developed.
• Lead the junior scientists in the team for Process Development/Process Validation / Process Characterization activities, including experimental designing, planning, supervising and directing studies.
• Process Characterization activities including Risk Assessment (FMEA), employing DoE methodologies, data analysis and interpretation to define process parameter ranges and process steps.
• Draft and review high quality technical documents- Protocols, reports, SOPs etc.
• Be the project representative delivering high-quality communication to ensure an outstanding customer experience (written documents, telecons, face to face meetings).
• Working as an integral part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project work stages.
• Purification activities include Chromatography (Affinity, Mixed-mode, ion exchange) using the AKTA purification system, Ultrafiltration/diafiltration and viral reduction strategies.
• Train new hires and junior scientists with existing/new technologies.
• Work with the highest scientific standards under the direction of the Line Manager.
• Communicate project updates to internal stake holders and external customers.
• Contribute to the efficient running of the department including instigating and delivering operational efficiency projects.
• Contribute to departmental safety and training programs as required.
• Technical supervision of projects and project teams may be required.

Education Experience

• Degree/PhD in a relevant Science field or equivalent.
• Minimum 4 years' work experience in relevant field or PhD with 2 years postdoctoral/ 3 years of industrial experience.
• The final role offered will be commensurate with the candidate’s experience.
• Expertise with relevant years of experience in protein purification process development.
• Experience in Process Characterization/Process Validation, involving the use of statistical software for experimental design and data analysis will be highly advantageous.
• Understanding of cGMP regulations will be advantageous.
• Excellent technical writing skills.
• Excellent communication skills (verbal and written).
• Good problem solving and analytical skills.
• Good team working 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.

#R60637

Posted Job Advert

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 Senior QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGMP contract manufacturing facility.

Key Responsibilities:

• Oversee daily Quality Assurance (QA) operations in line with approved SOPs and policies within a multi-product, cGxP contract manufacturing environment.
• Demonstrate strong motivation and exceptional expertise across all relevant job functions.
• Competently review and approve SOPs, protocols, reports, and records.
• Participate as an active member of cross-functional site teams handling various projects and issues.
• Coordinate multiple activities across departments, ensuring seamless communication and workflow.
• Exhibit excellent troubleshooting abilities, identifying process pathways and developing strategic improvements.
• Possess advanced knowledge of cGMP topics.
• Contribute to regulatory inspections or customer audits as needed.
• Lead or support improvement initiatives and strategic process developments.
• Quickly adapt to leadership roles in various process areas as required.
• Assume supervisory responsibilities in the absence of the direct supervisor.
• Comprehend and communicate the company’s business strategy while maintaining a wide-ranging perspective on operational trends and changes.
• Provide QA oversight to QC/DS lab services, Engineering, and Validation activities, reviewing documents and Trackwise records outside routine operations. Documents may include, but are not limited to, PQR, BLA content, new product introductions, qualification/validation strategies, gap assessments, and customer suspension/decommissioning processes.
• Actively participate in or lead complex investigations into deviations, change controls, CAPA proposals, and discrepancy reports using Root Cause Analysis tools to ensure timely and effective resolution.
• Oversee the proper implementation and timely closure of CAPA related to deviations.
• Support regulatory inspections or customer audits, confidently representing the company as a subject matter expert in QA oversight.
• Offer QA oversight for site-wide improvement projects, collaborating across departments to ensure clear communication and updates.
• Lead or assist in resolving complex process and project issues.
• Mentor and coach junior team members, fostering their development.
• Formulate and present solutions to internal and external teams and management.
• Represent QA Validation/Technical Compliance in decision-making processes during internal and external cross-functional meetings.
• Complete any additional tasks as assigned by the supervisor.

Key Requirements:

• Bachelor's degree or higher in Life Sciences or Pharmaceuticals, with significant experience in Validation and Quality roles within the Biopharmaceutical industry.
• A team player with 5+ years of relevant experience in a similar industry or role.
• Thorough understanding of regulatory requirements and local codes and standards (e.g., FDA, EMEA, ICHQ7).
• Practical and theoretical experience in quality management systems within GM facilities.

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 QC Expert you will be responsible for the supervision of all testing techniques and scheduling of testing with coordinating with the other departments delivering samples to ensure timely delivery of results. This role is also required to supervise the review of laboratory data (both internal and external) and the closeout of deviations.

Responsibilities

• Supervising the review of laboratory data (both internal and external) and the closeout of deviations
• Author and review Change Controls, Deviations/Investigation as well as Test Methods, Specifications and SOPs
• Perform report writing (Example: Deviations/Investigations/Trending)
• Maintains knowledge of new technologies
• Strong ability to manage multiple priorities and lead projects.
• Customer and regulatory agency interaction as required
• Problem solving of analytical/ microbiological methods as well as troubleshooting of equipment as applicable.
• Manage/perform equipment qualification and validation maintenance review
• Lead/ execute method transfers and validation/ qualification.
• Lead or participate in initiatives aimed at continuously improving quality processes and outcomes e.g. Lean Six Sigma methodologies, cost-cutting solutions, idea-box, etc
• Collect and analyze data related to quality metrics e.g. using statistical tools to identify trends, patterns, and potential areas for improvement
• Participate in Risk Assessment
• SME in 1 or more areas as aligned with training plan and known as go to person for technical advice.
• Able to make decision on the area of expertise
• Coach and train junior team member
• Participate and support in audit
• Any other duties as assigned by your manager

Experience:

• Bachelor’s or Diploma in a relevant science field or equivalent.
• Minimum of 10 years of experience in GMP (Good Manufacturing Practice) Quality.
• Relevant work experience, preferably in a laboratory setting, within the biotech or medical field.
• Individual contributor, high level understanding of QC activities and lab function

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 be responsible for performing day-to-day tasks of the QA Department in a GMP facility manufacturing clinical and commercial pharmaceutical products.

Key responsibilities:

• Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility
• Highly motivated individual and have superior skills in all areas relevant to the job
• Review executed batch records and logbooks efficiently to ensure compliance with cGMP per written procedures
• Compile lot genealogy
• Participate actively and approve deviation investigations, utilizing Root Cause tools to enable effective and timely closure of deviation investigations
• Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA
• Timely escalation of quality events on the floor based on knowledge of defined SOPs and policies
• Support changeover activities and QA on Call
• Provide training to new members and Participate in walkdown/ QA on Shopfloor and provide feedback to member of cross functional site team(s) on projects / issues
• Superior ability to troubleshoot; able to identify process pathway and work to develop improvement in strategy site team(s) on projects/ issues
• Understanding of advanced topics pertaining to cGMP
• Participate in Regulatory Inspections or Customer Audits as required.
• Identify process pathway and work to develop improvement in strategy
• Help/Transfer and quickly assimilate to leadership role in other process areas
• Assume Supervisory responsibility in absence of supervisor
• Any other tasks as and when assigned by supervisor

Key requirements:

• Bachelor Degree with relevant work experience in Quality Assurance in the Biopharmaceutical industry.
• Relevant QA Operations background from the Biopharma environment.
• Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
• Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
• Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMEA, andlCHQ7).
• 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.

Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five 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.

This is a newly created role and we are currently looking for a talented ERP Process/ Master Data Specialist to join our Supply Chain team in Singapore. You will be acting as the first level of support for the team, using your SAP knowledge to support the MRP and Production Scheduling team in planning and execution.

This is a great opportunity to explore multiple supply chain disciplines in the team and carve out an extensive supply chain career within Lonza.

Key Responsibilities:

• Creation and maintenance of part codes in SAP ECC.
• Creation and modification of BOMs, Recipes and Resources in SAP.
• Management of the deactivation/reactivation and discontinuation of parts in SAP ECC.
• Ownership of documentation (SOP's, Work Instructions, etc) related to new part set-up, BOM, recipe creations ensuring they are up to date and fit for purpose.
• Provide hands-on support to SAP users on site in the area of material master data and support the design and roll out of changes to the SAP system.
• Identify and implement opportunities to improve processes related to new part setup and other ERP-related activities.
• Monitor the progress of approval work flow to ensure that all materials move through the designated approval streams to meet GMP requirements.
• Any other duties as assigned by your Supervisor/Manager.

Key Requirements:

• BSc in Supply Chain Management or Business Management.
• APICS CPIM.
• Ability to influence both Supply Chain and functional leaders to support supply planning and site manufacturing strategy recommendations
• Good communication and presentation skills. Ability to present ideas in a clear and concise manner.
• Strong analytical skills with the ability to define metrics (KPI’s) and identify issues through root cause analysis.
• Competent using MS Office suite, particularly Excel and PowerPoint.
• Ability to utilize Business Intelligence systems to extract data and generate reports.

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.

As a Specialist you will be responsible for support and administration (system back-up, user access administration) for LIMS, MODA and other related Laboratory computerized systems. This role also requires to process the LIMS and MODA static data requests

Responsibilities

• Support and administration (system back-up, user access administration) for Sample Manager LIMS, MODA LIMS, iLAB, and other related Laboratory computerized systems
• Maintenance of LIMS static data (Sample Manager LIMS, MODA LIMS and STATISTICA systems)
• Support for installation and qualification/ validation of software related aspects of computerized instrumentation
• Actively contributes to operational efficiency/continuous improvement initiatives.
• Support system audit trail review all related Laboratory computerized systems
• Maintenance of software related changes to computerized instruments
• Server and database maintenance and administration as relates to laboratory systems
• Provide training for the roll-out of new computerized systems.
• Generation and execution of computer validation documentation (protocols and reports)
• Can identify computer related issues; troubleshoot, identify and complete or coordinate deviation, change control and/ or corrective action records.
• System/ equipment manufacturer and or vendor interaction as required in order to trouble shoot system issues.
• Available to troubleshoot and resolve critical system issues as they occur.
• Experience manages projects (people/ team environment) to meet the timelines.
• Customer and regulatory agency interaction as required.
• Oversight of computer system policies and procedure in order to ensure policy is aligned with current regulatory expectations.
• 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.
• SME in 1 or more areas as aligned with training plan.

Experience

• Degree/Diploma in relevant Science field or Equivalent
• Minimum 5 years of experience
• Relevant work experience preferably Lab related IT experience in a biotech or medically related field.
• Experience in lab computer systems essential (prefer experience with LIMS, and CDS –Chromatography Data Systems

​

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.

R63209

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 QC Expert you will be responsible for the supervision of all testing techniques and scheduling of testing with coordinating with the other departments delivering samples to ensure timely delivery of results. This role is also required to supervise the review of laboratory data (both internal and external) and the closeout of deviations.

Responsibilities

• Supervising the review of laboratory data (both internal and external) and the closeout of deviations
• Author and review Change Controls, Deviations/Investigation as well as Test Methods, Specifications and SOPs
• Perform report writing (Example: Deviations/Investigations/Trending)
• Maintains knowledge of new technologies
• Strong ability to manage multiple priorities and lead projects.
• Customer and regulatory agency interaction as required
• Problem solving of analytical/ microbiological methods as well as troubleshooting of equipment as applicable.
• Manage/perform equipment qualification and validation maintenance review
• Lead/ execute method transfers and validation/ qualification.
• Lead or participate in initiatives aimed at continuously improving quality processes and outcomes e.g. Lean Six Sigma methodologies, cost-cutting solutions, idea-box, etc
• Collect and analyze data related to quality metrics e.g. using statistical tools to identify trends, patterns, and potential areas for improvement
• Participate in Risk Assessment
• SME in 1 or more areas as aligned with training plan and known as go to person for technical advice.
• Able to make decision on the area of expertise
• Coach and train junior team member
• Participate and support in audit
• Any other duties as assigned by your manager

Experience:

• Bachelor’s or Diploma in a relevant science field or equivalent.
• Minimum of 10 years of experience in GMP (Good Manufacturing Practice) Quality.
• Relevant work experience, preferably in a laboratory setting, within the biotech or medical field.
• Individual contributor, high level understanding of QC activities and lab function

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.

R63329

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 an Associate Director of Technology/Method Transfer, you will be responsible for managing day-to-day activities in a GMP biotech contract manufacturing facility, ensuring compliance with approved SOPs and policies across multiple products. You will lead and oversee method transfer, validation, and lab studies while supervising or developing staff. The role involves providing critical support for customer projects, managing resources, and ensuring coordination across functions.

Key Responsibilities:

• Oversee laboratory activities such as assay transfers, disinfection studies, stability programs, equipment validation, and cleaning validation.
• Ensure the collection, management, and dissemination of project-related information to clients and internal teams.
• Coordinate project communications, reporting, and administrative tasks.
• Provide stakeholders with key data and updates on project status, including timelines, budgets, resources, and any delays.
• Ensure projects are completed within the approved budget, including resource planning, cost estimating, budgeting, and cost control.
• Act as a liaison between clients, QC, QA, and management, coordinating project plans, execution, and change controls.
• Manage cross-functional operational integration for project teams.
• Engage within the Lonza Global Network, building industry expertise both internally and externally.
• Apply advanced industry knowledge to make decisions autonomously.
• Communicate quality operations and compliance updates to senior management effectively.
• Review and approve SOP protocols, reports, and records.
• Lead or supervise staff in investigations, change control, CAPA proposals, and discrepancy report closures.
• Participate in global harmonization and efficiency projects.
• Support departmental budget control and capital expenditure management.
• Mentor, coach, and develop high-performing individuals and teams, ensuring succession planning for key roles.
• Contribute to organizational change and continuous improvement efforts.

Key Requirements:

• Degree or higher in Life Sciences/Pharmaceuticals with extensive experience in supervisory/project management roles within QC/QA.
• 10+ years of experience in quality or manufacturing operations in a GMP, FDA, and EU-regulated pharmaceutical environment.
• In-depth knowledge of regulatory requirements, including FDA and EMEA guidelines.
• Strong expertise in validation programs within GMP facilities.
• Demonstrated ability to set clear goals, prioritize tasks, and make balanced decisions to meet deadlines.
• A team player with a focus on safety, quality, and timelines.
• Lead organizational change.
• Excellent conflict resolution 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.

The QC Analyst will be responsible for Biochemistry Area in the QC Lab to support Lot Release activities

Responsibilities

• Prioritize and perform the various testing/analysis in timely manner, in order to support the business requirements.
• Analysis of final product, in-process, stability samples according to Standard Operating Procedures and Test Methods.
• Documentation and review of results in accordance with current Good Manufacturing Practices (cGMP).
• Understanding and execution of methods which may include ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, potency methods, and other physiochemical methods.
• General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.
• Prepare, maintain standards and reagents as 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.

Education / Experience

• Diploma / Degree or higher from recognized institution with at least 3 years’ experience in Quality unit in the Biopharmaceutical industry
• Relevant work experience preferably Lab experience in a biotech or medically related field
• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICH Guidelines)
• Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
• Is willing to take on new challenges
• Good interpersonal skills
• Effective Communicator (oral and written)
• Plans, prioritizes and organizes work to deliver on time
• Exhibit good quality decision making traits
• Meticulous and Systematic and Analytical Mind
• Team player who can operate independently, 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.

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 Development Services group is responsible for the development and characterization manufacturing processes used for the production of novel therapeutic recombinant proteins for Lonza’s global client base.

Based primarily in a new site in Singapore Science Park, the viral clearance team works closely with our customers, and with different functions including MSAT, Manufacturing, Regulatory, Proposal/Program Management, Process Development, Supply Chain, Quality Assurance and external testing facility.

As a Lead Scientist you will act as a Study Director to independently design and execute specific virus clearance studies that demonstrate the effectiveness of purification processes for the reduction of viruses to support customers’ regulatory filings (IND & BLA).

Key responsibilities:

• Function as a Study Director, who has the overall responsibility of planning and conducting, as well as the interpretation, analysis, documentation and reporting of results.
• Design viral clearance studies in accordance with guidelines (e.g. EMEA and ICHQ5A) and perform hands-on laboratory work (e.g. small-scale control run, virus models spiked run, virus inactivation step evaluation, virus reduction filtration) following protocols and working to GMP standards.
• Follow work procedures to set up and operate chromatography, ultra filtration and dead-end filtration systems to GMP standards.
• Review and interpret raw data to produce good quality process knowledge and data sets suitable for inspection by regulatory agencies.
• Authoring of protocols and reports and interaction with regulatory agencies required.
• Supervision of project teams and leading troubleshooting activities required.
• Develop and manage relationships with external customers and teams at contract testing laboratories.
• Deliver high quality communication to ensure an outstanding customer experience (written reports, telecons, face to face meetings).
• Work as part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project work stages

Key requirements:

• Degree/PhD in Biological Science/Engineering as appropriate for area of expertise.
• 4-7 years’ experience in a lab either in industry or academia, or via an industry work training programmed.
• Practical laboratory experience in virus clearance studies, study directing, and project management is required.
• Developing a detailed understanding of the scientific rationale behind one or more technical areas involved in the development of biopharmaceuticals.
• The final role offered will be commensurate with the candidate’s experience.
• Understanding of cGMP regulations and quality management is required.
• Excellent problem solving and analytical skills.
• Excellent communication skills (verbal and written).
• Excellent teamwork 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.

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 Purification Development team in Development Services, Lonza Singapore. As a Senior Scientist, you will be able to develop and enhance your technical and scientific capabilities as well as build on your technical leadership skills. You will be involved in hands-on experimental activities as well as supporting projects right from planning to delivery.

Duties and Responsibilities include:

• Perform hands-on laboratory work in the purification process development team contributing or leading the development of processes suitable for technology transfer to the cGMP manufacturing teams. An understanding of cGMP manufacturing facility constraints and their impact on development activities will be developed.
• Lead the junior scientists in the team for Process Development/Process Validation / Process Characterization activities, including experimental designing, planning, supervising and directing studies.
• Process Characterization activities including Risk Assessment (FMEA), employing DoE methodologies, data analysis and interpretation to define process parameter ranges and process steps.
• Draft and review high quality technical documents- Protocols, reports, SOPs etc.
• Be the project representative delivering high-quality communication to ensure an outstanding customer experience (written documents, telecons, face to face meetings).
• Working as an integral part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project work stages.
• Purification activities include Chromatography (Affinity, Mixed-mode, ion exchange) using the AKTA purification system, Ultrafiltration/diafiltration and viral reduction strategies.
• Train new hires and junior scientists with existing/new technologies.
• Work with the highest scientific standards under the direction of the Line Manager.
• Communicate project updates to internal stake holders and external customers.
• Contribute to the efficient running of the department including instigating and delivering operational efficiency projects.
• Contribute to departmental safety and training programs as required.
• Technical supervision of projects and project teams may be required.

Education Experience

• Degree/PhD in a relevant Science field or equivalent.
• Minimum 4 years' work experience in relevant field or PhD with 2 years postdoctoral/ 3 years of industrial experience.
• The final role offered will be commensurate with the candidate’s experience.
• Expertise with relevant years of experience in protein purification process development.
• Experience in Process Characterization/Process Validation, involving the use of statistical software for experimental design and data analysis will be highly advantageous.
• Understanding of cGMP regulations will be advantageous.
• Excellent technical writing skills.
• Excellent communication skills (verbal and written).
• Good problem solving and analytical skills.
• Good team working 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.

Lonza is currently looking to hire an Associate Engineer, Instrument Calibration to join the Engineering Team. You will be responsible for calibrating and troubleshooting GMP instruments at our Tuas manufacturing site.

Key responsibilities:

• Executes routine and calibration work orders as assigned by the Engineer/ Supervisor.
• Responsible for ensuring all GMP documentation related to calibration activities is completed accurately and processed to full completion.
• Perform shift or be available on-call when required & to support ongoing operations.
• Perform tasks that are routine in nature where the ability to recognize deviation from accepted practice is required.
• Ensuring regulatory/ customer inspection readiness.
• Perform calibration and basic troubleshooting problems related to field instrumentation.
• Ability to read PID drawing, Instrument loop drawing and instrument panel drawing.
• Executes calibration work order, follows calibration procedures & instructions.
• Performing calibration works on all equipment in the facility.
• Responsible for preventative maintenance and calibration of all instrumentation supporting manufacturing facility.

Key requirements:

• Diploma or a relevant Trade Certificate with a few years of relevant work experience in calibration of instruments in the Pharmaceutical/biopharmaceutical industry.
• Recent graduates are welcome to submit their application.
• Experience in troubleshooting of field instrumentation and working on tight schedules.
• Detailed and Quality conscious.
• Ability to follow SOPs and instructions.
• Diligent in performing operational checks.
• Experience in SCADA or DCS panel operations essential.
• Troubleshooting skills.
• Good Communication skills.
• Excellent 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.

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 Technical Writer is responsible for the development and/ or revision of Master Batch Records (MBRs) and other current Good Manufacturing Practice (cGMP) documents e.g. Standard Operating Procedures (SOPs), Work Instructions (WIs) used in the execution of manufacturing processes and/ or operations here onsite at Lonza Singapore. You will work very closely with Subject Matter Experts (SMEs) in Manufacturing Sciences and Technology (MSAT), Manufacturing (MFG), Quality Assurance (QA), Quality Control (QC), Validation (VAL) and any other relevant departments. The individual should have good understanding of manufacturing processes and operational knowledge of manufacturing equipment. In addition, attention to details is complimentary attribute required to ensure accuracies of the MBRs. This position reports to Senior/ Section Lead/ Manager of the Technical Writing Team (TWT), under Manufacturing Technical Team (MTT).

Key responsibilities:

• Develop new MBRs, using existing MBR templates, in support of Technology Transfers
• Maintain currency of MBRs for existing customers
• Produce high-quality documentation that meets applicable standards/ requirements of the users
• Write and edit technical information/ instructions in a manner to ensure content is factual and accurate
• Meet with SMEs to ensure specialized topics are appropriately addressed/ discussed
• Collaborate closely with relevant SMEs from various disciplines on documentation requirements
• Manage the lifecycle of MBRs including, but not limited to creation, review, revision and approval of MBRs on product campaign basis
• Maintain a system for tracking changes to be implemented in all upcoming product campaign
• Ensure MBRs adhere to approved template/ structure
• Communicate actively to address customers’ comments and to clarify customers’ queries with respect to MBRs
• Address comments arising from internal reviews and revise the documents accordingly.
• Deliver MBRs with strict adherence to the production schedule
• Provide assessments and insights to Change Requests from TWT’s perspective
• Define Change Tasks associated with TWT
• Ensure assigned CAPAs and Change Tasks are closed in a timely manner
• Attend planning and briefing meetings.

Key requirements:

• BS in Engineering (Chemical/ Biochemical) or Science (Biochemistry/ Chemistry/ Microbiology) related disciplines preferred
• Work experience in a cGMP regulated environment and prior technical knowledge in biopharmaceutical processing will be an advantage
• Strong technical communication and writing skills
• Excellent oral presentation skill
• Effective interaction skills with MSAT, MFG, QA, customers and auditors
• Strong proficiency in standard Microsoft Office applications e.g. MS Word and MS PowerPoint
• Advanced knowledge in Controlled Document Management System (DMS) Track record in completing projects under tight timelines
• Ability to quickly grasp and translate complex technical concepts to comprehensible instructional texts
• Ability to influence peers and teams with no direct reporting lines
• Competencies required: Business Acumen, Customer Focus, Driving Results, Leadership, Collaboration, Agility.

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.