Senior Biotechnologist

ABBVIE OPERATIONS SINGAPORE PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

ABBVIE OPERATIONS SINGAPORE PTE. LTD. is seeking a biologics production specialist to perform cGMP manufacturing operations within the production facility. You will work with engineers on set-up, calibration, rework and quality testing of parts, components, and final materials.

The role involves cell culture from vial thaw to production scale, data collection with LIMS/SAP, and collaboration with cross-functional teams. Shift work is required and compliance with audits is essential.

Qualifications

• Bachelor of Science with at least 5 years of experience in biologics production.
• 3+ years of area/stream specific experience.
• Experience with cGMP manufacturing operations.

Responsibilities

• Perform cGMP biologics manufacturing operations.
• Use LIMS, SAP and other systems to collect and evaluate data.
• Handle cell culture from vial thaw to production scale.
• Assign tasks within the shift team.
• Support supervisors in planning and area activities.
• Participate in audits and inspections.
• Review batch records and identify processing deviations.
• Provide independent problem solving and procedure development.
• Work rotating shifts.

Skills

Cell culture

Quality testing

Process optimization

Documentation

Education

Bachelor of Science

Tools

LIMS

SAP

Automated control systems

Job description

Major Responsibilities:

• 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.
• 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.
• 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.
• 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.
• Involved in cross-functional meetings.
• Initiates Demand Work Order.
• Reviews executed batch records and worksheets.
• Drivers the resolution of anomalous processing events.
• Sets a positive team environment and inculcates a nurturing AbbVie culture.
• Acting Supervisor when Supervisor is not available.
• As a highly skilled specialist, contributes to the development of concepts and techniques.
• Completes complex tasks in creative and effective ways.
• Consistently works 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.

Qualification and experience

• Bachelor of Science with at least 5 years of experience working in Biologics Production facility or equivalent.
• Experience should include 3+ years of area/stream specific experience.