Opportunity for an experienced biotechnologist with prior experience in leading Upstream (USP) teams for at least 1 year 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 manufacturing
• Must have at least 1 solid year of supervisory experience in Biotechnology/Pharmaceutical Manufacturing
• Upstream: prior demonstrated experience performing Cell culture (from vial thaw to production scale)
• 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.

Opportunity for an experienced professional to provide leadership, support, management, guidance and supervision for the API operations team to ensure that all day-to-day activities of operations run smoothly and seamlessly. You will ensure all performance metrics and workload deliverables are completed in alignment with the site’s business model

Role:

• Responsible for the supervision of API manufacturing and overall plant operations during the 12-hour working shift.
• Manage human-error related non-conformance as required, ensuring appropriate communication within the team and with cross-functional teams. Provide input to investigations.
• Resolve complex technical issues surrounding on-going processes and process equipment during the 12-hour working shift.
• Closely monitors the process of critical steps and ensures flawless execution
• Host meetings and escalate any production related matters to other cross-functions in a timely manner.
• Drive operational and process related improvements to achieve site business targets and manufacturing excellence.
• Performs daily Gemba walks with Manufacturing Manager/Lead/Supervisor to identify operational gaps or areas for improvements
• Assists Manufacturing Manager/Lead in planning and leading area activities.
• Assume the role of deputy in the absence of Manufacturing Manager/Lead
• Represent functional area during cross functional meeting where assigned by manager

Requirements:

• Degree in Chemical Engineering/Chemistry or equivalent technical related degree is required
• 8 to 12 years of relevant experience in working in a GMP manufacturing environment required, and at least 1 year of people management experience, such as being a shift lead or acting lead
• Able to work comfortably in 12-hour rotating shift (Day/Night)
• Leadership experience in training less experienced chemical technicians required