Associate Scientific Fellow, Process Analytics, Pharmaceutical Sciences

必須

• Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 15+ years relevant industry experience
• Master's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 13+ years relevant industry experience
• PhD in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 7+ years relevant industry experience
• Experience in CMC pharmaceutical development for active pharmaceutical ingredients.
• Significant technical and strategic leadership experience
• Experience working in a multi-disciplinary environment with accountability for informing departmental or functional strategy.
• Analytical and Critical Thinking Skills - Able to troubleshoot the critical issues or problems and determine causes and workable solutions.
• Teamwork - Ability to work well on global cross-functional teams.
• Communication Skills - Ability to express oneself clearly and concisely within team; documents issues and/or concerns concisely and comprehensively; adjusts communication style appropriate for the audience; timely and effectively communicates with senior management and direct reports; technical writing skills to support authorship of internal/external and approve internal technical documents.
• Business-level proficiency in both Japanese and English is required.
• Organization - Exercises suitable time management and prioritization skills to balance project and departmental objectives.
• Knowledge Sharing - ability to capture knowledge within the organization; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use.
• Resource Management - Project management skills and familiarity with financial aspects related to projects including ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital)
• External Involvement - Involved in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Communicate or applies industry trends. Advise team members or directly interacts with external vendors for projects.
• Leadership Skills - Demonstrated ability to manage up and down the organization; Ability to use appropriate management strategies to provide direction for the work of team members.
• Advanced proficiency with typical analytical tools (e.g., NMR, UV, IR, HPLC, Capillary HPLC, GC, Metal Analysis, Mass Spec, DSC, TGA, XRPD, DVS, Raman, etc.).
• Experience in organic chemistry or related field a plus.
• May require approximately 5-10% travel.

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Job Description

• Join Takeda as an Associate Scientific Fellow, Process Analytics where you will provide support for drug substance process chemistry and engineering research through specialized expertise in analytical method development for the purposes of reaction optimization and mechanistic understanding. You will provide technical oversight to staff, supporting team performance and outcomes. You will mandate a robust foundation in analytical chemistry, small molecule process comprehension, and adept collaboration with cross-functional teams to facilitate the successful development and refinement of small molecule drug substance processes. Additionally, the role involves collaborating cross-functionally to establish and supervise lab processes within the function related to data collection and analysis. As part of the Process Analytics Group for Small Molecule Process Development (Drug Substance), you will report to Head, Process Analytics, Synthetic Molecule Process Development.

How you will contribute

• Supports project teams for development of research methods, preliminary isolation/identification of process impurities during route scouting activities, reaction kinetics, and engaging on cross-functional teams to enable data platforms.
• Collaborate with drug substance process chemistry and engineering to design and execute experiments for process optimization, scale-up, and technology transfer activities.
• Provide analytical support and expertise to troubleshoot process-related issues and implement corrective actions in collaboration with Analytical Development.
• IPC method development for non-GMP/GMP steps and route scouting.
• Support for Analytical Development and Engineering and Technology for PAT method development (ex. HPLC calibration of methods).
• Method development support for innovation and technology in collaboration with Analytical Development.
• HPLC/GC method development that offers preliminary identification, and quantification of compounds in complex mixtures for high throughput experimentation (H.T.E.).
• Develop and manage strategies for departmental analytical infrastructure, resources, and projects for research methods in conjunction with senior staff.
• Collaboration with Analytical Development for platform consolidation of analytical data so that chemists and engineers can easily access data, accelerate processing time, and integrate results.
• Setup and coordination of maintenance/replacement of analytical instruments (UPLC, HPLC, LC/MS, GC, etc.).
• Analyze and interpret analytical data to assess process performance, identify trends, and make data-driven decisions to improve process efficiency and product quality.
• Generate technical reports and presentations to communicate findings to internal stakeholders.
• Stay updated on emerging trends and advancements in analytical chemistry, and process optimization methodologies. Identify opportunities for continuous improvement in analytical techniques, processes, and systems.
• Serve as a technical resource to guide group members in strategic decision making (and technical guidance as appropriate).
• Incorporate industry trends and company goals in departmental strategy.
• Ensure effective project management of all plans and projects within own responsibilities and site members of Process Analytics team.
• Contribute to cross-departmental strategy.
• Initiate or endorses complex projects with extraordinary technical challenges and applies broad technical risk assessment skills.