The role is responsible to lead the team for cell therapy product manufacturing. The current project is to ensure the design and layout of the manufacturing area can fully meet the operating and regulatory requirements. Key Responsibilities: • Review and optimize the layout of the manufacturing area. • Manage the team to adhere to safety and cGMP regulations. • Planning of daily activities in the cleanroom and providing the first line of problem-solving in case of any event. • Ensure critical supplies are in stock and available for production. • Coaching, mentoring, and performance review of the team. • Escalation to management and interaction with other stakeholders in case of any event. • Reviews and approves Batch Records, Change Controls, Deviations, and other documentation required for production operations. • The key contributor to technology transfer and all activities directly supporting campaign readiness. • Owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to quality, cost, on-time delivery, and right-first-time performance. • Team management, including optimal resources allocation, hiring, gap analysis, and talent development. **2026年初工作地點:竹北廠區**
待遇面議
(經常性薪資達 4 萬元或以上)
•Master's degree in biology, chemistry, or other related majors. •Above 5 years of working experience in the pharmaceutical background is Peferred. •Good verbal and English writing skills are preferred. •Experience with cell therapy equipment such as Sepax, CliniMACS, ACC-200, etc is preferred. •Strong working knowledge and experience of cGMP regulations. •Experience with Quality Systems including Deviations, and Change Controls. Experience with TrackWise is preferred. •Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment. •Process transfers and campaign readiness experience. •Significant experience with leading production/ manufacturing projects from concept to completion in a pharmaceutical/ biotechnology production environment. •Exceptional aseptic manufacturing process background **2026年初工作地點:竹北廠區**
樂迦致力於為員工提供全方位的關懷與支持,以下是我們的福利措施,希望每位員工都能在這裡感受到家的溫暖與成長的機會: 1.員工年終獎金:感謝大家一整年的辛勤努力與付出,年終獎金將如期發放,以表達我們對您貢獻的感謝與肯定。 2.定期健康檢查:為了關心員工的健康與福祉,我們定期提供免費健康檢查,讓大家保持最佳的身心狀態。 3.教育訓練機會:我們提供各種教育訓練機會,幫助員工持續學習、提升專業能力,與公司共同成長。 4.慶生會:每月定期舉辦慶生會,為壽星們送上最誠摯的祝福與驚喜,讓每位員工都能感受到公司的溫馨關懷。 5.生日假期:在員工的生日,我們提供特別的生日假期,讓您在這一天享受放鬆與喜悅。 6.團體責任保險:我們為員工提供團體責任保險,保障您的安全與未來。 7.免費咖啡與零食:為了讓大家在忙碌的工作中隨時補充能量,我們提供免費咖啡與零食,讓您在工作中享受片刻的小確幸。 8.員工旅遊:每年安排員工旅遊,讓大家放鬆心情、增進團隊凝聚力,與同事們一同創造美好的回憶。 9.生育賀禮:我們為迎接新生命的員工提供生育賀禮,祝福員工的家庭幸福安康。 10.員工團險:提供員工團體保險保障,讓員工在工作和生活中都能安心。 11.在職修讀補助:我們鼓勵員工進修,並提供在職修讀補助,支持員工提升學歷和專業能力。 透過這些福利措施,讓每位員工都能感受到樂迦的真誠關懷與支持,並在這個充滿愛的大家庭中共同成長,攜手邁向更美好的未來。