We are seeking a dynamic, results-driven, and resilient Supervisor / Team Lead to spearhead our Solution Preparation (Media & Buffer Preparation) operations at our Singapore CRDMO Hub in Tuas. This is a pivotal leadership position offering a front-row seat to building, training, and operationalizing a world-class large-scale formulation department from the ground up.
As a Supervisoe/Team Lead, you will bridge the gap between strategic site timelines and daily shop-floor execution. You will lead a talented team of biotechnologists and engineers, fostering a culture of safety, accountability, and continuous improvement.
Responsibilities
- Responsible for the day-to-day management of the group and department (Solutions prep and Production support)
- According to the production plan, be accountable for the team to clean and sterilize the parts and consumables for production.
- Be accountable for overseeing the operation and cleaning of disposable system and stainless steel-system as well as the preparation of culture medium and buffer according to GMP requirements.
- Accountable in overseeing troubleshooting of issues pertaining to equipment and processes (including Automation issues).
- Accountable for the planning and establishment of material and supply production schedules, SAP operation, monitoring of material inventories, tracking the progress of production, provide support to production scheduling on all material flow issues to meet production schedules and customer requirements.
- Accountable for the overall environmental monitoring such as air sampling, water sampling, steam sampling, surface sampling for Commercial DS Manufacturing department.
- Accountable for overseeing the draft/revision of SOP/MBR/URS/FAT/SAT and other documents.
- Accountable for overseeing material ordering, tracking, management and inventory status. Contact suppliers and vendors as required.
- Accountable for the shipping/receiving/delivering of materials to make sure all material after received from the warehouse follow the SOPs to remove outer packaging, complete the proper cleaning procedure, and deliver to assign location and all in good shape
- Overseeing and participate in the investigation and implementation of relevant changes and deviations as well as audit and rectification activities.
- Feedback process, personnel, safety, production environment, maintenance and other issues to leaders in a timely manner.
- Be responsible for overseeing the receiving, reviewing and managing the materials workshop for production.
- Overseeing staff’s training or coordinating training, and maintaining individual training record on time.
- Communicates with engineering or related departments to coordinate the maintenance and measurement of equipment plant.
- Participate in the investigation and implementation of relevant changes and deviations as well as audit and rectification activities.
- Be responsible for cooperating with other GMP work within the department, such as logbook review, BPR review, cleaning and sterilization of parts and consumables, etc.
- Responsible for drafting/upgrading SOP/MBR etc.
- Overseeing and take part in the project tech transfer related works.
- Be responsible for team building and personnel gradient management in the group, and create a positive atmosphere in the group.
- Overseeing equipment management and maintenance related works.
- Responsible for the routine group and department administrative affairs.
- Carry out any other responsibilities assigned by direct line manager
Requirements:
- Bachelor degree in Chemical/Biochemical Engineering, Generic Engineering, Biochemistry, Electrical& Instrument
- Knowledge and at least 8 years of experiences in a similar manufacturing industry or cleanroom environment preferred and at least 5 years of people management experiences is preferred.
- Knowledge about MES, PCS (Delta V, Unicorn) etc. in production plants is preferred
- Strong coordination and interpersonal skills. Able to work cross-department and work with multi-discipline to drive project to success.
- Good knowledge on GMP, 21 CFR Part 11 and EU Annex11 regulation and requirement.
- Good English communication skills.
- Positive team-oriented demeanor.
- Self-motivated, quick paced with flexibility to meet aggressive timeline.