Bristol Myers Squibb

Senior Specialist, Cmc Associate

1 month agoTokyo, Japan

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

概要 (High-level Description; including manage team/individuals or not)

  • BMSKKの企業目標を達成するため,開発,承認審査(JNDA/sJNDA)及びライフサイクルマネジメントの各ステージにおけるCMC薬事戦略を立案し,これに基づいて業務を遂行する。そのために,BMSKK内外の情報を入手し,最新の薬事規制を理解し,規制当局(医薬品医療機器総合機構(PMDA)/厚生労働省)との適切なコミュニケーションを図る。
  • 開発チーム,申請チームに参画する。上長又は上位者の指導のもと,CMC薬事戦略を立案し,業務を遂行する。
役割 (Roles & responsibilities)

上長又は上位者の指示,指導のもと,開発,承認審査(JNDA/sJNDA)及びライフサイクルマネジメント,並びに治験薬製造管理における役割を果たす。
  • 各ステージにおいてリスクアセスメントを行い,必要に応じてリスクマネジメントプランを立案し,遂行する。
  • クロスファンクショナルチームにおいて,CMC薬事の立場からの検討を行い,開発戦略に関わる適切な情報を提供し,チームに貢献する。
  • 上司又は上位者の指導のもと,関係部署(グローバルチームを含む)に対して,薬事的,技術的なアドバイスを行う。

開発:
  • 治験届に必要な情報を提供する。また,治験届のCMC関連添付資料が必要な場合,治験届提出時期を考慮し,グローバルチームと連携して資料作成を行う。
  • 日本市場に受け入れ可能な製剤開発が進められるよう他部署と協力してグローバルチームへ情報提供する。
  • バイオ医薬品についてクリティカルな製造方法の変更や品質に大きく影響する開発計画については,他極の相談実施状況を的確に判断し,グローバルチームと連携してPMDA相談の実施を検討する。
  • 製剤に含まれる添加剤については使用前例の確認及び生物由来原料基準への適合性の確認を行い,必要に応じて関連部門へ情報提供する。

承認審査(JNDA/sJNDA):
  • PMDA相談:グローバルチームとの協議を通じ,期待される回答を得るための戦略を立案,合意し,これに基づいて資料を作成する。
  • CTD作成:グローバルチームと協議し,薬事要件を満たし,かつグローバルチームの合意を得たCTDを作成する。
  • GMP適合性調査:承認時期及び製造所のバリデーション実施時期を考慮して,適正なタイミングで調査申請する。実地調査では,当局による製造所のGMP文書の確認及び承認書に関わる調査をサポートする。また,当局と製造所の良好なコミュニケーションにより,調査が円滑に進められるように調整し,サポートする。書面調査では,製造部門から必要な書類を入手し,妥当性を検討した上で当局へ提出する。
  • 当局対応:PMDA相談,承認審査,GMP適合性調査などにおける当局からの照会の意図,意味をグローバルチームへ正しく説明し,適切な回答となるように調整する。回答内容について合意を得た上で,当局へ回答する。

ライフサイクルマネジメント:
  • 製造部門の変更管理に基づき,一変申請,軽微変更届出といった薬事対応が必要な事案に対して,製品供給の面から,品質管理部門,マーケティング部門などの関連部署の状況から適切な薬事戦略を立案して薬事対応を行う。
  • 一変申請においては承認時期の管理を製造部門の情報に基づいて行う。
  • 製品に関する社外からの問い合わせに関係部署(メディカルインフォメーション等)と連携して対応する。
  • 製品の品質に関する関連部署(製造部門,GQP部門等)からの問い合わせ又はサポート依頼に対応する。
  • ライフサイクルマネジメントに関わる業務の円滑化を図るために他部署との調整が必要な場合は上長に報告する。

必要な知識/スキル (Required knowledge/skills)
  • 次に掲げる申請業務(新薬申請,一変申請)のいくつかについての経験又は知識
    • 申請資料(承認申請書及びCTD)作成
    • JAN申請
    • GMP適合性調査(国内外)
    • 外国製造業者認定
  • 次に掲げるもののうちいくつかについての経験又は知識
    • 日本薬局方
    • 有機合成,分析化学,タンパク質化学,生化学,微生物学
    • 製剤開発
    • 製造管理,品質管理(GMP,GQP)
    • 軽微変更届出
    • 原薬等登録原簿(国内管理人との調整)
  • 英語でのコミュニケーションスキル
    • 必要に応じて上司又は上位者のサポートを得ることにより,グローバルチームとの会議(電話会議含む)に出席し,業務を遂行できる。

High-level Description; including manage team/individuals or not
  • Provide appropriate CMC regulatory strategy in each stage of development, approval review (JNDA/sJNDA), and life cycle management in order to achieve BMSKK business goal, and execute tasks according to this strategy. For that objective, obtain information from the inside/outside of BMSKK and understand the latest regulatory requirements. In addition, communicate appropriately with regulatory authorities (Pharmaceuticals and Medical Devices Agency (PMDA) / Ministry of Health, Labour and Welfare).
  • Take part in the development team and JNDA/sJNDA team. Along with supervisors/ senior colleagues, propose CMC regulatory strategy and execute tasks.
Roles & responsibilities

Fulfill his/her responsibilities in the stage of development, approval review (JNDA/sJNDA), life cycle management, and manufacturing and control of investigational medical products (IMPs) while receiving instruction/guidance from supervisors/superiors.
  • Carry out risk assessment in each stage. As necessary, propose and implement risk management plan.
  • Contribute to cross-functional team through having regulatory discussion from CMC regulatory aspects and providing appropriate information regarding the development strategy.
  • Provide regulatory and technical advice to related parties including Global teams while receiving instruction from his/her supervisor or senior colleagues.

Development:
  • Provide information needed for Clinical Trial Notification (CTN). If necessary, cooperate with global team and prepare CMC-related attached documents for CTN in consideration of submission timing.
  • Provide information to Global team in order to develop pharmaceutical products that are acceptable in Japan.
  • Evaluate the necessity of PMDA consultation for biologics based on outcomes of other countries in collaboration with Global team, if critical manufacturing process change is needed and/or development plan, which will impact products quality, is developed.
  • Evaluate excipients from viewpoints of new excipients (precedence of excipients) and biological ingredients standard and share the information to relevant department if necessary.

Approval review (JNDA/sJNDA):
  • PMDA Consultation: Plan strategies and gain agreement through discussion with Global team in order to receive expected response. Prepare documents according to the strategies.
  • CTD Preparation: Prepare CTD through discussion with Global team that the contents of CTD meet the regulatory requirements and are aligned with agreement with Global team.
  • GMP inspection: Submit application forms for GMP inspection at the appropriate timings in consideration of planned approval timing and site situation on process validation. As for the on-site based inspections, support the authorities in order to confirm GMP documents of manufacturing sites and inspection related to the approval documents. In addition, facilitate and support communication between the authorities and the manufacturing site. For the GMP paper-based inspections, submit required documents, which are obtained through the manufacturing sites, after review of the contents of documents.
  • Communication with the authorities: Regarding the PMDA consultations, approval review, and GMP inspections, submit responses prepared as outlined in the agreement of Global team through explanation on meaning of queries, discussion and negotiation for generation of the best responses.

Life cycle management:
  • Based on the information of change control initiated by manufacturing department, propose appropriate regulatory strategy and execute regulatory tasks in the point of view of product supply and the situation of Product Assurance and Marketing.
  • Control approval timing of the partial change application based on the information of manufacturing department.
  • If inquiries on commercial products arises from outside of BMS, take appropriate actions in cooperation with related parties (Medical information, etc.).
  • Facilitate inquiries/support from the parties related the product quality (manufacturing department, GQP, etc.).
  • Inform supervisor when negotiation with other parties is necessary in order to facilitate task related to the life cycle management.

Required knowledge/skills

Experience and knowledge in some of the following application items (JNDA/sJNDA and Partial Change Application)
  • Preparation of application documents (Application form and CTD)
  • JAN application
  • GMP inspection (domestic and overseas)
  • Foreign Manufacturer Accreditation

Experience or knowledge in some of the following items;
  • Japanese Pharmacopoeia
  • Organic synthesis, chemical analysis, protein chemistry, biochemistry, and microbiology
  • Pharmaceutical development
  • Manufacturing control and quality control (GMP, GQP)
  • Minor Change Notification
  • Master File (coordination with In-Country Caretaker)

English Communication skill
  • Can attend meetings (including audio conference) with global teams and carry out tasks while receiving support from his/her supervisor, if necessary.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Job ID: BristonMyers-R1537037