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Manufacturing Science Process, Associate Director

募集中
応募
  • 勤務地
    大阪府
  • 職種
    その他製剤化/製造・生産関連職
  • 業種
    医薬品メーカー（先発医薬品）

募集要項

業務内容 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.

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.
雇用形態 正社員
応募資格 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.35 lbs.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
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
英語力 ビジネスレベル
年収 1300万 〜 1700万円
給与詳細 ■給与: 経験・スキルに応じ当社規定により決定します
基本給　月￥649,800～
＊残業手当は残業時間に応じて別途支給
諸手当：通勤手当、住宅手当、残業手当等
昇給：毎年
賞与支給：年2回
想定年収　1300万円-1700万円
勤務地 大阪府
備考 ”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us.
global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

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