掲載期間:21/08/03~22/02/02 求人管理No.017447

外資大手製薬メーカー

Senior Manger, Production Manager, External Manufacturing

  • 大企業
  • 年間休日120日以上
  • フレックス勤務
  • 転勤なし
  • 社宅・住宅手当有
  • 退職金制度有
  • 管理職・マネージャー
  • 英語を活かす

募集要項

外資大手製薬メーカーにて委託製造組織(CMO)での製造活動を管理していただきます。

仕事内容

・General and team・Function as a key point of contact for all interests/activities at Contract Manufacturing Organizations (CMOs)
・Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders, developing a partnership approach
・Live and support deployment of the values
・Act as a resource for CMO stakeholders on their requests to stakeholders and vice versa

・Production・Provide operational oversight of CMOs to ensure all deliverables meet or exceed requirements This includes but is not limited to negotiating manufacturing slots aligned with needs, ensuring compliant and timely manufacturing, OTIF shipments, quality compliance and cost management) - be the ‘eyes and ears’ at the CMO for flawless execution of commercial operations
・Leverage VPT stakeholders to provide guidance to CMOs and ensure cross-functional alignment on priorities and deliverables
・Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing
・In close relation with CMO and VPT stakeholders, lead, prioritize and track efficient execution and documentation of key activities to meet requirements. This includes, but is not limited to initiation, execution, tracking and closure of change controls, investigations and deviations.
・Identify and escalate business-critical issues effecting Compliance, Operations and Management
・Participate in regular staff and governance meetings to agree on priorities and tactics
・Maintain and communicate list of unbudgeted and extraordinary charges for resolution with CMO and visibility to management

・Project management・Manage a portfolio of multiple cross-functional external manufacturing projects, with a focus on developing and maintaining overall project plan objectives and timelines
・Collaborate with CMO and internal stakeholders to understand planned changes, set priorities, define required budget and resources, and manage the end-to-end implementation process including but not limited to change controls and impact assessments
・Support product, technical and business process lifecycle management activities
・Lead or support other CMO or VPT-related projects

・Performance and continuous improvement・Act as the key liaison to facilitate post-campaign / periodical (as applicable) and CAPA effectiveness review at CMOs
・Establish a robust tracking and reporting process to ensure compliance with internal/external audit observation deadlines or other regulatory commitments.
・Facilitate collation of data to track CMO and VPT performance and compliance on metrics including but not limited to adherence to contractual agreements such as on-time-in-full (OTIF) delivery and release, spend/budget, product quality and supply integrity
・Facilitate process improvement initiatives with CMO, VPT and supporting business processes
・Track and ensure compliant and timely execution and closure of responses to audit and inspection observations or of other regulatory commitments
・Create and maintain process maps and tools, maintain related SOPs and work instructions up to date, in collaboration with other VPT representatives.
・Collaborate with other VPTs to exchange experience and best practices
・Support root cause analysis and risk assessments

応募条件
【必須事項】
・Bachelor’s degree in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.).
manufacturing, quality, or biopharmaceutical development.
・Strong quality and compliance background in a commercial GMP operational environment; sound working knowledge of health authority regulations
・Strong technical background in aseptic operations.
・Solid project management skills and experience managing complex projects.
・Ability to expresses one’s self clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
・Strong leadership and an innate ability to collaborate and build relationships is critical.
・Ability to work calmly and make sound decisions in an environment of uncertainty and change
・Flexibility to work shift hours required to cover critical process steps
・Represent as a leader when issues arise.
【歓迎経験】
【免許・資格】
【勤務開始日】
応相談
学歴
大学卒以上
雇用形態
正社員
試用期間
3ヶ月

契約期間
勤務地
東京
転勤の有無
転勤なし
受動喫煙防止措置
勤務時間
フレックス制度あり コアタイムなし
休憩時間
時間外労働
勤務開始日
応相談
休日休暇
完全週休2日制(土・日)、祝日
創立記念日
年末年始休暇
年次有給休暇(入社年、入社月に応じ最高10日。初年度13日。以降、1年ごとに加算、最高20日)
年収・給与
経験により応相談
諸手当
通勤手当、持ち車制度、駐車場補助
住宅手当または借上社宅制度(地域・扶養家族により異なる)
赴任手当、単身赴任制度、別居手当、転勤休暇、振替出勤手当
子女手当、MR手当 退職年金制度、財形貯蓄制度
昇給
年1回
賞与
年2回
採用人数
1名 
待遇・福利厚生
【待遇】
業務災害休業、通勤災害休業、災害救済貸付、災害見舞金、罹災休暇
総合福祉団体定期保険、団体傷害保険、医療費貸付、私傷病有給欠勤制度
人間ドック補助金、定期健康診断、生活習慣病検診、婦人科検診補助
各種検査補助(肝炎ウイルス、HIV、大腸、乳がん検診)
健康診断特別休暇、インフルエンザ予防接種補助
【福利厚生】
選考プロセス
1)書類選考
2)一次面接
3)二次面接
4)最終面接

外資大手製薬メーカー

Senior Manger, Production Manager, External Manufacturing

  • 大企業
  • 年間休日120日以上
  • フレックス勤務
  • 転勤なし
  • 社宅・住宅手当有
  • 退職金制度有
  • 管理職・マネージャー
  • 英語を活かす

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