Opportunity for an experienced biotechnologist with prior experience in leading Upstream (USP) OR Central Services teams for 2 to 3 years within the biologics production facility to join an established biopharma in West of Singapore.

Role:

• Provide leadership, support, management, guidance and supervision for the Biologics group to ensure that all day-to-day activities of operations run smoothly and seamlessly.
• Assure that all performance metrics, workload deliverables are completed in alignment with the sites business model.
• Build and maintain collaborative relationships with other team members within the site and departments.
• Responsible for supporting Cell Culture, Central Services and Purification areas.
• Performs general to complex duties in assigned area within the Biologics Production facility.
• Complies with safety requirements, current Good Manufacturing Practices, and Standard Operating Procedures.
• Organize daily and weekly shift activities and direct junior personnel in execution of daily and weekly tasks.
• Operates equipment including Media Preparation, Buffer Preparation and Glass Wash/Autoclaves, bioreactors, inoculum transfers, filtration and chromatography equipment.
• Performs set-up and sterilization of components and process equipment, monitors and adjusts equipment operation
• Coordinates process sampling and routine measurements
• Ensures that data is recorded, activities logged, and processes monitored appropriately.
• Interfaces with automated production systems and controls.
• Reviews records for completeness and accuracy.
• Authors or revises standard operating procedures.
• Coordinates activities in the startup and validation of new equipment or new areas.
• Trains junior members as a qualified/certified trainer.
• Communicates all events/issues with appropriate individuals.
• Initiates or implements changes of both physical and written procedures.

Requirements:

• Bachelor of Science with at least 8 to 12 years of relevant experience, especially in the area of biologics upstream or central services manufacturing
• Must have at least 2 solid years of supervisory experience in Biotechnology/Pharmaceutical Manufacturing;
  • Upstream: prior demonstrated experience performing Cell culture (from vial thaw to production scale) OR
  • Central Services: prior demonstrated experience operating glass washer / autoclave, performing raw material sampling, weighing, dispensing and Buffer/media preparation 
• Strong working knowledge of Microsoft and other software packages (SAP, LIMS)
• Experience with cGMP documentation and record maintenance
• Strong problem solving and prioritization skills

• Proficient in core and related work processes, and able to implement improvements to work processes.
• Knowledge of complex technical issues and manufacturing experience in a biopharmaceutical / pharmaceutical or similar environment.
• Shift work is required.

Interested applicants, please submit your profile to submitCV@talentreq.com for review. We will be in touch for initial discussion upon being shortlisted

EA Licence: 17S8795 | EAP: R1108333

Opportunity for an experienced biotechnologist with prior experience in leading downstream (DSP) teams for 2 to 3 years within the biologics production facility to join an established biopharmaceutical manufacturing in West of Singapore. You will oversee downstream manufacturing processes including large-scale chromatography, viral inactivation, and aseptic filling of bulk drug substances.

Role:

• Provide leadership, support, management, guidance and supervision for the Biologics group to ensure that all day-to-day activities of operations run smoothly and seamlessly.
• Assure that all performance metrics, workload deliverables are completed in alignment with the sites business model.
• Build and maintain collaborative relationships with other team members within the site and departments.
• Responsible for supporting Cell Culture, Central Services and Purification areas.
• Performs general to complex duties in assigned area within the Biologics Production facility.
• Complies with safety requirements, current Good Manufacturing Practices, and Standard Operating Procedures.
• Organize daily and weekly shift activities and direct junior personnel in execution of daily and weekly tasks.
• Operates equipment including Media Preparation, Buffer Preparation and Glass Wash/Autoclaves, bioreactors, inoculum transfers, filtration and chromatography equipment.
• Performs set-up and sterilization of components and process equipment, monitors and adjusts equipment operation
• Coordinates process sampling and routine measurements
• Ensures that data is recorded, activities logged, and processes monitored appropriately.
• Interfaces with automated production systems and controls.
• Reviews records for completeness and accuracy.
• Authors or revises standard operating procedures.
• Coordinates activities in the startup and validation of new equipment or new areas.
• Trains junior members as a qualified/certified trainer.
• Communicates all events/issues with appropriate individuals.
• Initiates or implements changes of both physical and written procedures.

Requirements:

• Bachelor of Science with at least 8 to 12 years of relevant experience, especially in the area of biologics downstream manufacturing
• Must have at least 2 solid years of supervisory experience in Biotechnology/Pharmaceutical manufacturing downstream area
• Strong working knowledge of Microsoft and other software packages (SAP, LIMS)
• Experience with cGMP documentation and record maintenance
• Strong problem solving and prioritization skills
• Proficient in core and related work processes, and able to implement improvements to work processes.
• Knowledge of complex technical issues and manufacturing experience in a biopharmaceutical / pharmaceutical or similar environment.
• Shift work is required.

Interested applicants, please submit your profile to submitCV@talentreq.com for review. We will be in touch for initial discussion upon being shortlisted

EA Licence: 17S8795 | EAP: R1108333

Opportunity for an experienced biotechnologist with prior experience in biologics facility to perform functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials.

Role:

• Responsible for Cell culture (from vial thaw to production scale), Buffer/ media preparation, column chromatography, tangential flow filtration and sampling of in process and raw materials.
• Use sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment and determine and may assist in developing methods and procedures to control or modify the manufacturing process
• Assigns tasks within the shift team to other biotechnologists
• Assists Supervisor in planning and leading area activities to ensure adherence to schedule
• Involved in regulatory/internal audits and inspections, and in cross-functional meetings
• Initiates Demand Work Order, reviews executed batch records and worksheets
• Drives the resolution of anomalous processing events
• Sets a positive team environment and inculcates a nurturing culture
• Acting Supervisor when Supervisor is not available

Requirements

• Bachelor of Science with at least 4 years of experience working in Biologics Production facility or equivalent, of which at least 3 years spent in a specific area/stream experience
• As a highly skilled specialist, you will contribute to the development of concepts and techniques and completes complex tasks in creative and effective ways.
• Experienced working on complex assignments requiring independent action and a high degree of initiative to resolve issues.
• Makes recommendations for new procedures.
• Acts independently to determine methods and procedures on new assignments.
• Assists Supervisor in planning and leading area activities.
• Shift work is required

Interested applicants, please submit your profile to submitCV@talentreq.com for review. We will be in touch for initial discussion upon being shortlisted

EA Licence: 17S8795 | EAP: R1108333