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| 部署・役職名 | 大阪市/Associate Director, Manufacturing Science for Plasma Drug Substance, Japan New Plasma Facility |
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| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
We are seeking a highly skilled and motivated Plasma Manufacturing Process Scientist to join our team. As a Process Scientist, you will play a crucial role in the successful tech transfer of plasma processes and products to our new plasma facility in Japan. Reporting to the Head of Manufacturing Science, you will be responsible for driving process validation strategies and ensuring the robustness and reliability of our manufacturing processes. This includes oversight of fractionation, purification, and fill－finish processes which are critical to plasma product manufacturing. Join our team and contribute to the advancement of plasma manufacturing processes in Japan！ [Responsibilities] 1. Collaborate closely with pharma science, regulatory, and quality control organizations, as well as process experts across our global plasma network. 2. Provide leadership and guidance to team members, assisting them in prioritization, problem resolution, and process clarification. 3. Direct the effective transfer of technology from design development to implementation. 4. Evaluate the suitability of new technologies for implementation and transition to the manufacturing floor. 5. Ensure successful product technical transfer to the new plasma facility. 6. Establish reliable yield status and accurate yield forecasts for all transferred products, implementing strategies to meet yield targets. 7. Develop and direct strategies for yield improvement projects, lead time reduction, process security, and deviation reduction. 8. Assure process robustness and supply reliability by controlling the manufacturing process life cycle. 9. Develop strategic plans that incorporate regional and global business practices and customer needs. 10. Define and communicate strategic imperatives for project success, including market entry timing, innovative technology, and costs. 11. Develop effective tech transfer project milestones, schedules, and manage budgets. 12. Utilize state－of－the－art project management tools to ensure project schedules and budgets are met. 13. Identify and resolve issues that may impact project schedules or improve project time. 14. Understand and effectively communicate market niche and competitive forces influencing the project. 15. Ensure team objectives align with key tech transfer projects for the new facility. 16. Proactively prioritize and balance resource utilization for the project. 17. Select, develop, and retain staff, providing constructive feedback, recognition, coaching, mentoring, and motivation. 18. Generate innovative solutions to complex problems using multiple disciplines and technical principles. 19. Create innovative products, processes, and methods through novel combinations of expertise within the organization. 20. Perform other duties as assigned. [Working Environment] － Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. － No make－up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment. － Will work in a cold, wet environment － Must be able to work overtime as required （APPLICABLE TO SNE only）. － May be required to work in a confined area. － Some clean Room and cool/hot storage conditions [Important Notice concerning working conditions] It is possible the job scope may change at the company’s discretion. It is possible the department and workplace may change at the company’s discretion. |
| 労働条件 |
■勤務地 <大阪工場>大阪市淀川区十三本町 ・阪急「十三駅」徒歩8分 ■給与 ◎想定年収1,200万円～1,500万円 ※ご経験、採用ポジションによる（面談時にご説明致します） ・諸手当：通勤交通費、借家補助費、勤務時間外手当など ・昇給：原則年1回 ・賞与: 原則年2回 ■勤務時間 ◎勤務時間8:00～16:45 ・所定労働時間7時間45分 ・休憩60分 ■雇用形態 正社員 試用期間3ヶ月 雇用期間の定め：有 ■休日休暇 ◎年間休日123日程度 ・週休二日制 ・メーデー ・年末年始 ・年次有給休暇 ・特別有給休暇 ・傷病休暇、ファミリーサポート休暇 ・産前産後休暇、育児休暇、子の看護休暇、介護休暇 ・ボランティア休暇 ■待遇・福利厚生 ・社会保険完備 ・独身寮・社宅 ・財産形成：従業員持株会、財形貯蓄、住宅融資、企業年金制度 ・保養所（全国各地） ・人材育成支援制度 |
| 応募資格 |
【必須（MUST）】 [Qualifications]1. Utilize your strong scientific background to contribute to the development and optimization of plasma manufacturing processes. 2. Apply your knowledge of GMPs, FDA, EMA, PMDA, Lean, Six Sigma, and DMAIC methods to ensure compliance and continuous improvement. 3. Demonstrate self－motivation, strong interpersonal skills, and the ability to analyze and solve complex problems through innovative thought and experience. 4. Utilize project management tools to effectively manage multiple cross－functional teams simultaneously. 5. Design and implement projects/studies outside your area of expertise, leveraging your scientific knowledge and skills. 6. Provide strategic leadership and supervision to ensure the success of process development and tech transfer projects. 7. Utilize your experience in change management to drive process improvement initiatives. 8. Demonstrate a high level of customer orientation and organizational skills. 9. Embrace a flexible and innovative mindset, thinking outside the box to drive continuous improvement. 10. Communicate effectively, both verbally and in writing, to convey complex scientific concepts and project updates. 11. Leverage your record of success in process development, tech transfer, project management, and regulatory submissions to drive the success of our plasma manufacturing processes. 12. Collaborate with cross－functional teams in a highly matrixed, cross－functional, and geographically dispersed environment. 13. Utilize your experience in GMP inspections to ensure compliance with regulatory requirements. [Education and/or experience] 1. Bachelor's degree in a science－related field required; Master's or PhD degree in a technical/scientific education, preferably biochemistry, biotechnology, or pharma, is preferred. 2. At least 5 years of professional experience in a similar role in the field of Technical Operations, Process Management, or Manufacturing within the pharmaceutical industry, with significant experience in fractionation, purification, and fill－finish processes. 3. Excellent verbal, written, and interpersonal communication skills in English and Japanese. 4. Ability to build relationships, influence, and drive organizational engagement in a highly matrixed, cross－functional, and geographically dispersed environment. 5. Strong knowledge and application of GMPs, FDA, EMA, PMDA, Lean, Six Sigma, and DMAIC methods. 6. Proven experience in process development, tech transfer, project management, and regulatory submissions. [Physical Demands] Must be able to lift, push, pull and carry manufacturing equipment/tools up to 15kg （35lbs）. In general, the position requires a combination of sedentary work and walking around observing conditions in the facility. |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/07/29 |
| 求人番号 | 3731687 |
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