神奈川 化合物管理業務 高度技術者

クライアントである製薬メーカーに代わって、主に下記の書類を作成していただきます。 1.臨床試験の計画書や報告書 2.医薬品の承認申請資料

自社のデータマネージャー向けに、臨床試験の症例情報を正確・効率的にDB化するためのシステムをユーザー要求・要件定義の段階から構築、運用(保守)までを担って頂きます。 まずはプログラマーとしてシステム開発を担当後、プロジェクトマネジメントスキルを身に着けていただきます。 【具体的な業務内容】 ■ユーザー要求、計画書作成の対応 ■機能仕様書の作成 ■設計仕様書、各詳細仕様書の作成 ■システム開発の実施 ■システムテストの実施と対応 ■ユーザー受入テストの対応

医薬品開発に関る臨床試験、製造販売後臨床試験におけるモニタリング業務。 モニタリング業務（全て又は一部）を行っていただきます。 契約事項、GCP、SOP、その他関連する法規制等を遵守し、受託したプロジェクトにおけるモニタリング業務全般の実施、また治験実施計画書等に従って治験が実施されていることをモニタリングする責務を担っていただきます。 分業制ではなく、試験の立ち上げから終了までの一連の業務に携わることができます。

臨床試験等によって集積された症例データについて、医学的観点を含む各種チェックを行い、統計解析ならびに関連法規に耐えうる電子データを作成する業務。

Accountabilities: Develops project or significant technical strategy and leverages technical skill(s) as a resource/expert within the department Contributes significantly and independently to project work which may include multiple projects within functional area. Plans and implements resolutions to technical problems/issues Independently designs and executes experiments, and reports results Recommends, justifies and implements technologies and innovations. Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills. Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally. Reviews, interprets and communicates data cross functionally within pharmaceutical sciences and project teams Conducts analysis of technical and conceptual risk and trends Identifies process trends and defines/champions process strategy or use of novel technologies Recognized as a technical expert and resource within function Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff. Defines appropriately complex/novel approaches and methodologies to solving outstanding technical challenges Coordinates and leads technology transfer to internal or external manufacturing sites Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts. Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals. Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors. Represents is an active member on pre-competitive collaborations with academic and industrial partners. Education and Experience: A Ph.D. degree with 3+ years of academic, post-doctoral or pharmaceutical industry experience; an MS degree with 9+ years of pharmaceutical industry experience; or a BS degree with 11+ years of pharmaceutical industry experience. Degrees in chemical engineering required. Experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred Experience in building reaction kinetic models as well as process models preferred. Experience in building laboratory and pilot plant equipment a plus Experience in crystallization process development and scale-up with an emphasis on form, purity, and particle size control a plus Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control a plus Experience in the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.) required Experience in building chemometric models preferred Experience in developing continuous processes a plus Sound knowledge of current Good Manufacturing Practices (cGMP) preferred Experience working in a pilot plant a plus Previous experience with the use of contract facilities and managing technical transfers a plus Experience in working in a multi-disciplinary team environment Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts

Accountabilities： Leads and manages a group of Engineers, providing technical guidance, mentoring, and performance management to ensure the team's success and professional growth. Develops project and/ or significant technical strategy and leverages technical skill(s) as a resource/expert within the department. Collaborates closely with cross-functional teams, including process chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and implement effective process engineering strategies. Drives process optimization initiatives to improve sustainability, process efficiency, yield, quality, and cost-effectiveness, utilizing expertise in process chemistry and fundamental engineering principles. Oversees process scale-up activities from laboratory to pilot plant and commercial-scale production, ensuring smooth technology transfer and process validation. Has full accountability for all engineering aspects for multiple pipeline projects. Initiates complex projects with extraordinary technical challenges and applies strong technical risk assessment skills. Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills. Contributes significantly to develop, drive and set the vision and direction of departmental activities, management of resources, time, personnel and financial resources. Maintains ownership of overall vision of scientific platform. Communicates and coordinates implementation of technology/scientific improvement to senior management, across therapeutic and scientific areas. Conducts analysis of technical and conceptual risk through robust process characterization, failure mode analysis, and risk assessment methodologies, identifies trends and defines and champions process or scientific strategies. Incorporates novel manufacturing, technologies and industry trends as a key aspect of scientific strategy development. Maintains complete technical responsibility for program(s)/initiative(s) within the department. Leverages cross functional knowledge to guide pharmaceutical sciences teams on potential impact of actions across projects, particularly in technical aspects. Ensures effective project management of all plans and projects within area of responsibility, linking all scientific efforts to company, program and functional goals. Leads small working groups as appropriate to address knowledge gaps in programs linking departmental strategy to strategies of other relevant functions. Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff. Recognized as a technical leader/resource by the group and fosters development of technology skill sets within department and among junior staff. Contributes to departmental strategy around scientific improvement and new capabilities. Makes proposals regarding sourcing/consultancy strategy. Coordinates and leads technology transfer to internal or external manufacturing sites or vendor Communicates with senior management of other functions on implementation of infrastructure, technology, work processes, or business processes. Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), process descriptions and peer reviewed manuscripts. Defines outsourcing strategy for department in conjunction with senior staff. Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver against pipeline goals. Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors. Represents is an active member on pre-competitive collaborations with academic and industrial partners.