Total 7 job vacancies by Lonza Bioscience Singapore Pte. Ltd.

Today, Lonza is a global leader in life sciences 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.

Responsibilities:

• Perform various testing/analysis (bioburden, LAL, plating and counting techniques, microbial identification, EM tests i.e. air sampling, surface viable sampling, total particulate sampling etc.) in timely manner.
• 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.
• Analysis of bulk product 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.
• Generation of required trending and reporting information, document revision and update.
• Support / Perform OOS, deviation investigations. Draft investigations reports.
• 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

Experience

• Degree/Diploma in a relevant Science field or Equivalent
• 0-5 years’ experience in Quality Control
• Strong knowledge of microbiological laboratory operations in a manufacturing environment
• Demonstrates an ability and desire to learn from experience
• Good problem solving and analytical skills
• Good communication skills
• Experience with USP 71 Sterility testing is preferred

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 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.

As a Senior QC Analyst, you will leverage your technical expertise in a variety of testing techniques and collaborate with cross-functional teams to ensure timely project delivery.

Requirement:

• Provide technical leadership in biochemical testing, including cell counts, flow cytometry, ELISA, PCR analysis, and compendial testing (pH, Conductivity, Appearance) as per USP, JP, and EP standards.
• Troubleshoot equipment and method-related issues by analyzing data and trends to resolve problems.
• Collaborate with tech transfer teams to introduce new processes or modify existing ones, acting as the lab's designated point of contact.
• Lead complex projects, coordinating various project teams to ensure successful completion and effective communication across all stakeholders.
• Prepare and manage project documentation, including Method Transfer, Qualification, Validation reports, and product stability programs.
• Oversee preventative maintenance and requalification of stability-related equipment.
• Contribute to Annual Product Reviews and regulatory documents and provide guidance to junior staff.
• Support continuous improvement initiatives and participate in audit activities when needed.
• Proactively communicate risks to managers and the Head of QC.

Requirements:

• Degree in a relevant scientific field or equivalent.
• 5-10 years of QC experience, preferably in biotech, healthcare, or life sciences.
• Expertise in bioassays (ELISA, PCR, FACS) and ability to maintain quality standards while achieving results.
• Strong analytical and decision-making skills, with a desire to continuously learn and grow.

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.

Responsibilities:

• Support daily Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, GMP biotech manufacturing facility.
• Planning for future activities and coordinate with other departments to complete the workflow.
• Develop skills to be Qualified Trainer in area of expertise.
• Develop in depth awareness of entire process; identifying operational factors which influence the process.
• Participates in Regulatory and Customer Audits.
• Support in performing gap assessments between group documents and or regulatory guidelines
• Participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports.
• Ensure real-time decisions on process events on the floor based on knowledge of defined SOPs & policies.
• Develops good working relationships with internal & external customers.
• A competent Reviewer and Approver of SOPs, protocols, reports or records.
• Lead a small team and provides supervision to QA Coordinators, interns or Specialists.
• Any other tasks as and when assigned by supervisor.

Requirements:

• Bachelor's degree with 2-5 years’ experience in Quality Assurance in the Biopharmaceutical industry.
• Relevant QA Operations background with experience in leading small team for projects.
• Experience in deviation investigation, change control and CAPA activities.
• 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.
• 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 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 is an exciting position who is responsible for QA oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Cell and Gene Therapy entity. Role will provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements ( FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1,” Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820).

The role will also provide strategic plan and expertise for the development and implementation of the Microbial Control Strategy. Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release.

Key responsibilities:

• Provide support and expertise to ensure that Cell and Gene Therapy (CGT) and Media preparation operations and support functions for Cleanroom management, Materials Management, Aseptic practices, Environmental monitoring (EM). Sterilisation methods, and Aseptic process simulations (APS) to confidently deliver CT products to patients with the highest quality sterility assurance level.
• Review policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations and sterility failures.
• Provide Sterility assurance expertise to support APS/EM deviations and investigations, CAPAs and Complaints related to aseptic processing.
• Review of sterile filter validations, integrity testing and procedures.
• Provide expert support and assessment to business partners including production, MSAT, Engineering, QC and QA assuring adequate facilities contamination prevention practices, monitoring tools are provided to production to guarantee the best EM indicator levels.
• Involvement in global harmonization/ efficiency projects; begin to lead aspects of global projects within specific areas.
• Represent site in global forums from sterility assurance perspective. Collaborate with stakeholders of different functions to lead/implement various global/site projects to support sterility assurance.
• Support regulatory and client audits as Aseptic sterility assurance subject matter expert
• Responsible for the generation of key performance indicators, GEMBA walks, regulatory compliance and efficiency targets.
• Communicate quality operations and compliance perspective effectively to senior management.
• Understand and articulate company business strategy. Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates.

Key requirements:

• Engineering/ Life Science Diploma/Degree or higher from recognized institution with significant years of QA or QC Sterile processing and Microbial experience in similar capacity.
• GMP experience in the biologics industry is required.
• Working knowledge of microbiological and sterility testing, media fills, environmental monitoring , clean room qualification and management, quality control endotoxin testing and microbiological control strategy required.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required.
• Experience in cell culture, cell or gene therapy experience is a plus.

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.

R63423

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 role is responsible to lead process/ technology transfer into Lonza Singapore Cell Therapy facility. Role is also responsible to perform process support in troubleshooting and deviation investigation of product impact justifications.

Key Responsibilities:

Technical transfer

• Lead/ Support the timely and successful transfer of customer’s manufacturing process into the Lonza Bioscience Singapore production facility.
• Work with other MSAT team members, technical experts from Lonza’s customer companies and work with:
• Manufacturing team on training and resource planning for execution of pilot runs/ engineering runs/ study runs.
• Supply Chain Management team on reviewing material package for raw materials requirements and bill of materials (BOM) setup.
• Project Management team on project deliverables and customer communications.
• Quality Assurance (QA) team on regulatory and compliance requirements of the manufacturing process.
• Quality Control (QC) team on developing sampling plan.
• Validation team on equipment validation for new customer/product introduction into the facility.
• Perform analysis and design of process fit and process-scale up in collaboration with vendors, customer technical experts or Lonza’s Process Development and MSAT teams of other sites.
• Design and perform experiments on scale down process in MSAT lab to support process technology transfer. Follow all applicable lab safety policies.
• Author and/ or approves of process-related documents i.e. Process overview, APS protocols, development/ investigative protocols and reports.
• Develop and define training programs and requirements to facilitate integration of new manufacturing process into Lonza Bioscience Singapore production facility.
• Interact with customer technical experts as necessary to progress technology transfer.

Process support

• Performs technical review/ approvals of batch records, process SOPs, deviations, change controls, training documents, protocols, development/ investigative reports, CAPAs.
• Support investigations into process issues/ deviations and if required, coordination of the associated troubleshooting activities and/or perform experiments in the MSAT small-scale cell culture process lab. Follow all applicable lab safety policies.
• Manage change control implementation for process changes that are driven by process changes/ improvements and coordination of non-GMP and/or non-clinical runs.
• Lead/ support pre-campaign preparation activities.
• Oversight on the production floor to provide support and review of operations. Escalate issues to management appropriately and interface with customer on issue resolution.
• Oversight of on-going trainings to ensure alignment between training and process requirements.
• Monitor manufacturing run process data and monitor for run-to-run consistency.
• Identify and drive implementation of process improvements as required.
• Support inspections and audits by customer and regulatory authorities as required.
• Support plant start-up and pilot/clinical/commercial run. Perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues in operations, and participate in the generation and assessment of required change controls.
• Able to recognize abnormalities and/or potential event that might affect process, product quality and/or safety & escalate promptly to the appropriate level for attention.
• Able to apply problem-solving tools such as 5Whys, 5M, fishbone diagrams to identify root causes.
• Any other duties assigned by your manager.

Key Requirements:

• Degree in Chemical Engineering, Biotechnology, Chemistry or a related discipline.
• Relevant experience in Biotechnology process development, process support, research or a related manufacturing environment is advantageous.
• Prior hands-on experience in adherent, human cell culture experimental technique and equipment.
• Knowledge of Excel as well as Statistical Data Analysis tools.
• Experience in using TrackWise to perform change control, effectiveness check, corrective actions and preventive actions (CAPAs) is highly desirable.
• Experience in troubleshooting processing related issues and/or equipment is desirable.
• Knowledge of Operational Excellence tools and concepts such as Lean manufacturing and Six Sigma.
• Excellent communication skills, outstanding action orientation, and ability to work well in a fast pace, cross-functional technical environment.
• Analytical with good technical writing 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.

Key responsibilities:

• Work with colleagues to maintain a daily/weekly work schedule to cover day-to-day business priorities.
• Collaborate with management to support customer satisfaction initiatives.
• Ensure timely and effective management of customer order releases.
• Supports in the investigation of complaints and credit requests; validation of claims of product/ lot purchases, and compliance against all applicable requirements.
• Serves as the first escalation point for product returns and customer credit requests and act as a backup for other Customer Service Representatives.
• Creating intercompany purchase orders and updating in the SAP system; Confirming import shipping documents and coordinating delivery dates to our 3PL warehouse with forwarders
• Order inbox assignments & management, order entry for orders received via electronic and manual methods, processing credits and debits, inbound phone calls, replacements, returns, complaints and some complex products (i.e., reserve order material, products with characteristic selections
• Review and edit orders to ensure accuracy and timely delivery of materials and follow-up or re-promise of order commitments.
• Ensure proper documentation is attached to orders within all systems.
• Process activities in compliance with established Customer Service Procedures, SOP and SDS requirements. Lonza’s ISO 9001 certification requires compliance with these procedures.
• Document all customer contact interactions in order text tabs or as when necessary in SAP/ SFDC, tell the ‘story’ to enable correct and consistent response to customers.
• Determine validity of each price by reviewing the customer's Purchase Order and all pertinent items. Review additional items to determine all factors related to each quotation, including contacting Pricing and Contracts Team when needed.
• Perform other duties as assigned.

Key requirements:

• Diploma/ Degree in any field
• Proficient in MS Office and SAP is a must
• Proficiency in Japanese, both written and verbal, JLPT3 and above is required for this role as you will be working closely with the Japanese team based in Japan.

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 an Associate Director, you will manage a sales team varying between 2-8 staff. Responsible to deliver target profit and revenue for their segment and region. Actively leads their team and defines and manages sales representatives’ activities (KPIs) and coaches the development of the desired sales competencies to meet their profit and revenue goals as well as specific MAP deliverables.

Key Responsibilities:

• Supervises, leads and manages the sales team.
• Develops and trains the sales team to build capabilities and skills.
• Accurately forecasts and delivers on quarterly and annual sales targets.
• Manages the sales funnel from new opportunity generation through closing.
• Demonstrates advanced understanding and appropriately communicates the Bioscience portfolio and Lonza’s value proposition to customers.
• Demonstrates advanced product knowledge capabilities, applications, regulatory knowledge, and product justification in order to be recognized as the expert in the field.
• Advanced understanding of assigned accounts including site locations, departments, key decision makers, and decision-making process.
• Advanced understanding of market knowledge and competitor landscape.
• Organizes, plans, and schedules time to provide optimum and effective account and territory coverage.
• Record activities and client information in the CRM database on a daily and timely basis.
• When requested, acts as team lead to coach others to achieve high performance.
• Perform other duties as assigned.
• Ability to travel up to 60%

Key Requirements:

• Knowledge and experience in drug discovery, drug manufacturing/QC, Cell & Gene Therapy, and the biotech/biopharma industry.
• Core people management skills (activity management, competency development, problem resolution, etc.).
• Core selling skills (prospecting, funnel management, closing, etc.), including creating customer value, consultative selling, technical selling, and effective sales presentation.
• Computer software skills including Microsoft Office and CRM.5. Interpersonal skills and comfort with public speaking in front of small groups.
• Communicate effectively and collaborate successfully within own team as well as cross-functionally.
• Effective listening skills, independent and self-directed, team-oriented, strong work ethic.

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.