募集要項
| 業務内容 |
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. |
|---|---|
| 雇用形態 | 正社員 |
| 応募資格 |
Required: A Ph.D. degree with 7+ years of academic or pharmaceutical industry experience; an MS degree with 13+ years of pharmaceutical industry experience; or a BS degree with 15+ years of pharmaceutical industry experience. Degrees in chemical engineering required Extensive experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred. Extensive experience in building reaction kinetic models as well as process models preferred. Extensive experience in building laboratory and pilot plant equipment preferred. Experience in crystallization process development and scale-up with an emphasis on polymorph, 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 preferred. Experience managing staff preferred. 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). Experience working in a pilot plant a plus. Previous experience with the use of contract facilities and managing technical transfers. Experience in working in a multi-disciplinary team environment. Significant technical and strategic leadership and accomplishments Previous experience contributing to regulatory filings, preferably experience will late stage filings. Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts. Knowledge and Skills: Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions Teamwork -- Ability to work well on global cross-functional teams. Communication Skills -Able to express oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents Organization – Exercises good time management and prioritization skills to balance multiple project and departmental objectives Technical - Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use |
| 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 | 神奈川県 |
| 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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関連する求人
・化合物管理用自動倉庫、各種分注機のオペレーション ・化合物溶液分注操作の品質管理 ※当ポジションは基本出社での勤務となります
- 450万〜685万
- 神奈川県
- CRO
募集中
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
- 900万〜1300万
- 神奈川県
- 医薬品メーカー（先発医薬品）
募集中