Total 9 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.

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 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.

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 Manager, Customer Projects, QC will be responsible for coordinating with external customers and working inter-departmentally to enhance communications at all levels and ensure that work activities, compliance and documentation issues are resolved in a timely manner.

Key responsibilities:

• Superior ability to troubleshoot all applicable equipment / methods (subject matter expertise). Strong ability to manage multiple priorities.
• Strong ability to manage multiple priorities.
• Source of expertise for rest of staff.
• Work with tech transfer teams to prepare new processes; act as responsible lab designee.
• Own & Lead Special projects, often complex in nature; including direct responsibility for leading various teams to successful completion of various projects.
• Validation / Tech or Process Transfer Work: Lead execution, troubleshooting, coordination, client interaction.
• Can identify lab problems, troubleshoot, identify and complete or coordinate corrective action.
• Work inter-departmentally to enhance communications at all levels and ensure that work activities, compliance and documentation issues are resolved.
• Lead and approve report (Example: Method Qualification / Validation, / Investigations).
• Ensuring that the project is completed within the approved budget
• Includes the overall project coordination of resource planning, cost estimating, cost budgeting, and cost control as part of the SOW (Scope of Work) assessment.
• Act as interface with clients, QC, and line management for integrated project budget/resources.
• Ensure that the various elements of the project are properly coordinated including overall coordination of project plan development, project plan execution and change control.
• Manage the process of cross-functional integration of operational activities for the project team.
• Provide expert planning and operational support to the project.
• Contribute to the creation of the development plan/production plan and other project information.
• Any other tasks as and when assigned by 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.
• Advantage if candidate is able to lead the shift team to meet the in-process demand samples turnaround time.
• Good understanding of HPLC and Empower software.
• 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.
• Provide support in HPLC equipment maintenance and qualification.
• Well versed in cGMP regulations.