Total 4 job vacancies by Cellvec Pte. Ltd.

Job Responsibilities:

Procurement support:

• Organize and perform procurement activities.

• Request for quotations, sourcing, simple bid evaluations, award of order, and post award for non-complex material.

• Correspond with vendors regarding prices, product availability, and delivery.

• Preparation for vendor evaluation assessment form

• Track orders to ensure timely deliveries.

• Prepare shipping documents (like commercial invoices, purchase orders, packing lists, and delivery notes).

• Maintain updated records of orders, suppliers, and customers.

• Oversee the levels of our stock and place orders as needed.

• Provide information to customers about the status of their orders.

• Support for the Quality team for Supplier qualification

• Prepare expiry report and perform scrap transaction monthly.

• Manage and maintain stock levels in the GMP warehouse and R&D warehouse, Item code creation and management in SAP.

Warehouse Operations support:

• Be a team member of the warehouse for supporting for warehouse daily operations.

• Ensure proper storage of goods and maintain good housekeeping.

• Carry out warehouse activities efficiently and comply with safety standards and guidelines.

• Plan and perform warehouse operations for goods receipt, issuance, and shipping.

• Perform inventory cycle count per SOP and investigate and implement corrective actions for inventory discrepancies.

• Participate in annual stock count.

• Effectively communicate and implement company initiatives, policies, and SOP’s

• Work with other departments to deliver functional goals and initiatives

• Work with the Facility Engineering team to carry out warehouse equipment maintenance, calibrations, and requalification of Warehouse systems and equipment are performed within the due date

• Support for managing cryogenic tanks and liaise with service providers for smooth operations.

• Support for deviations, initiations, and investigation closure for warehouse-related non-conformances

• Support for warehouse operations related SOP’s, Forms, and Qualification documents generation and updates

• Work with third-party cleaners for warehouse periodic cleaning

• Work with the team (Finance, Business development, and Project team) for planning and costing for production runs.

• Responsible for warehouse document management, document entry, completeness, review, and Archival procedure.

• Support for warehouse internal and External Audits.

• Any other ad hoc duties as assigned by the Warehouse supervisor

Product and Raw Materials Testing:

• Develop and qualify method of analysis (MOA) for QC lot release testing
• Perform analytical testing such as flow cytometry (FACS) and qPCR assay to support QC lot release.
• Perform stability testing of released final products as per protocol and timeline.
• Perform functional/comparability testing of raw materials such as plasmid, media, reagents and etc.
• Support assessment of certification/accreditation and services provided by external labs for QC lot release testing

Documents and Data Management

• Drafting and updating of relevant SOPs and specification documents for lab, equipment, test method, training and raw materials.
• Author and review technical protocols and test reports, develop guidelines and standard practices for data documentation and analysis.
• Review test results, document data and produce trends in an efficient, organised and presentable manner to facilitate discussions, and to support business and performance metrics reporting.

Deviations and Audit Management

• Assist OOS/test deviations initiation, investigations, root cause analysis and CAPA implementation for product defects and quality lapses.
• Support internal and external audits/inspections.

Equipment and Lab Management

• Monitor and schedule equipment calibration and maintenance as per schedule and site master file.
• Perform lab housekeeping, equipment, inventory, lab cleaning and biohazard/waste management.
• Perform monitoring and procurement of lab inventory, for e.g. materials and cosumables.

Continuous Improvement

• Implement initiatives to encourage improvement of QC procedures, activities and workflows.
• Conduct routine literature review through established publication channels to ensure continual knowledge proficiency on both GMP and current technological trends relevant to CellVec activities.

Key responsibilities:

• Learn and perform well-defined procedures in GMP manufacturing setting and Research and Development Settings
• Perform equipment monitoring and basic housekeeping
• Perform laboratory testing (e.g. pH/ Conductivity/Cell Density / Viability, Mycoplasma, PCR test and Flow Cytometry … etc.)
• Perform routine clean room sanitization tasks to maintain the clean room ISO standards
• Demonstrate aseptic technique in the handling of product/ materials and requirement to participate in Aseptic Process Simulations.
• Multi-task exposure on cGMP manufacturing and Validation Task and Research and Development trail runs.
• Support for protocol preparation, execution, and summary report for validation run and development studies
• Attain full competency in the performance of all operations as assigned.
• Become a technical process expert by exhibiting basic understanding of critical process/operational parameters and target/acceptable ranges, as well as interactions between different process parameters.
• Use Standard Operating Procedures (SOPs), logbooks & Batch Manufacturing Records (BMR’s) effectively & competently
• Taking part in the internal and external audit.
• Support for change control, deviations, investigations and CAPA initiation and closure
• Assist in process development, in creating scalable processes with improved product yield and reduced manufacturing systems costs
• Support Facilities Engineering Team to perform maintenance, troubleshooting, calibration, and repair instrumentation (where applicable).

Cell Culture (Upstream)

• Skill and knowledge of aseptic technique for thaw and subculture stages using T flasks and Cell Factories, etc.
• Knowledge of handling Cell Culture, Trypsinization, Centrifugation and Resuspension. Cell Culture Passaging from flask / cell factories.
• Benchtop set up for Cell Culture Supernatant Clarification

Purification (Downstream)

• Skill and knowledge of small-scale column chromatography techniques, tangential flow filtration techniques, final filling techniques in BSC and isolators
• Knowledge in handling single use chromatography columns and tangential flow filtration skids.

Key requirements:

• Degree/Diploma in a related Science/Engineering discipline
• 1 to 3 years relevant work experience in a similar manufacturing industry or cleanroom environment
• Knowledge of Viral Vector manufacturing and Gene Therapy application is an added advantage.
• Knowledge of cGMP applications
• Positive team-oriented attitude
• Strong communication and interpersonal skills
• Flexible to adjust the schedule to support GMP manufacturing and R&D trial Runs.

Job Responsibilities:

Procurement:

• Organize and perform procurement activities.
• Request for quotations, sourcing, simple bid evaluations, award of order, and post award for non-complex material.
• Correspond with vendors regarding prices, product availability, and delivery.
• Preparation for vendor evaluation assessment form
• Track orders to ensure timely deliveries.
• Prepare shipping documents (like commercial invoices, purchase orders, packing lists, and delivery notes).
• Maintain updated record of orders, suppliers, and customers.
• Oversee the level of our stocks and place orders as needed.
• Provide information to customers about the status of their orders.
• Support for the Quality Team for supplier qualification
• Prepare expiry report and perform scrap transaction monthly.
• Manage and maintain stock levels in the GMP warehouse and R&D warehouse, item code creation and management in SAP.

Warehouse Operations:

• Be a team member of the warehouse for supporting for warehouse daily operations.
• Ensure proper storage of goods and maintain good housekeeping.
• Carry out warehouse activities efficiently and comply with safety standards and guidelines.
• Plan and perform warehouse operations for goods receipt, issuance, and shipping.
• Perform inventory cycle count per SOP and investigate and implement corrective actions for inventory discrepancies.
• Participate in annual stock count.
• Effectively communicate and implement company initiatives, policies, and SOP’s
• Work with other departments to deliver functional goals and initiatives
• Work with the Facility Engineering team to carry out warehouse equipment maintenance, calibrations, and requalifications of Warehouse systems and equipment are performed within the due date
• Support for managing cryogenic tanks and liaise with service providers for smooth operations.
• Support for deviations, initiations, and investigation closure for warehouse-related non-conformances
• Support for warehouse operations related SOP’s, Forms, and Qualification documents generation and updates
• Work with third-party cleaners for warehouse periodic cleaning
• Work with the team (Finance, Business development, and Project Team) for planning and costing for production runs.
• Responsible for warehouse document management, document entry, completeness, review, and archival procedure.
• Support for warehouse internal and external audit.
• Any other ad hoc duties as assigned by the Warehouse supervisor

Job Requirements

• Diploma or equivalent in Logistics/Supply Chain management
• At least 2 years of experience in Procurement and Admin support
• Good understanding of Logistics and Supply Chain processes
• Exposure to logistics software (i.e., SAP) will be advantageous.
• Effective communication skills and experience in deviations write up will be advantageous.
• Expected to work independently, fast paced and dynamic work environment.