Associate Scientist, Process Analytics, Pharmaceutical Sciences

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Job Description Associate Scientist, Process Analytics About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as an Associate Scientist, Process Analytics where you will provide support for process chemistry and engineering efforts through specialized expertise in off-line analytical method development aimed at route scouting, optimizing reactions and understanding mechanisms for synthetic molecules. You will also provide theoretical and conceptual input to the design, development, and execution of research assignments for specific projects.

Additionally, you will independently plan and execute most unit operation characterization and optimization experiments within their area of expertise and develop an awareness of unit operations in other areas. This role is responsible for significant or sole technical leadership within projects or complex studies, proactively identifying process or study issues and challenges, and proposing potential resolutions.

As part of the Process Analytics (PA) Group for Synthetic Molecule Process Development (SMPD, Drug Substance (DS)), you will report to Head, Process Analytics, Synthetic Molecule Process Development. How you will contribute: Support project teams for development of research methods, preliminary isolation/identification of process impurities, reaction kinetics, reaction mechanism and data management.

Collaborate with drug substance process chemistry, analytical development 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.

IPC method development for non-GMP/GMP steps and research development routes. Off-line support for Process Analytical Technology (PAT) methods (ex.

HPLC calibration of methods). Method development support for innovation and technology team.

HPLC method development that offers identification, and quantification of compounds in complex mixtures for high throughput experimentation (H.T.E.). Preliminary identification of process impurities by Mass Spec (MS).

Residual solvent analysis. Fit for purpose, genotoxic impurity method development for investigational routes.

Analyze and interpret analytical data to assess process performance, identify trends, and make data-driven decisions to improve process efficiency and product quality. 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. Technology advancement: work cross-functionally to ensure continued innovation for the PA team and SMPD.

Platform consolidation of analytical data so that chemists and engineers can easily access data, accelerate processing time, and integrate results. Contribute to complex/multiple projects or functional areas through leading or influencing others.

Influence and support initiatives related to driving scientific and technical improvement within function and potentially cross-functionally. Ensure a productive and development-rich environment.

Define more complex/novel approaches and methodologies to solving complex technical challenges. Identify vendors and build relationships to gain access to technologies as needed to deliver pipeline goals.

Understand project timelines and deliverables and plan/coordinate project work accordingly with departmental, functional, and external stakeholders. Provide technical leadership to project teams within area of expertise.

Contribute significantly and independently to project work which may include multiple projects within functional area. Review, interpreting and communicating data cross-functionally within CMC (Chemistry, Manufacturing & Controls) and project teams.

Plan and implement resolutions to technical problems/issues. Independently design and execute experiments, and reports results.

Responsible for integrating scientific/technical efforts around cross-functional issues. Minimum Requirements/Qualifications: Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 5+ years relevant industry experience Master's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 3+ years relevant industry experience PhD in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 0+ years relevant industry experience Requires a foundation in analytical chemistry, reaction kinetics, and the ability to collaborate with cross-functional teams to facilitate the successful development of synthetic drug substance processes.

Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and workable solutions. Teamwork -- Ability to work well in highly cross functional team environment and across global line functions.

Communication Skills -Able to expresses 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 issues to supervisor; technical writing skills to support authorship of internal technical documents. Organization – Exercises time management and prioritization skills and can successfully manage multiple tasks simultaneously.

Knowledge Sharing: Ability to capture organizational knowledge; improve solutions, processes, and deliverables through information; improve information capital by contributing experience, theories, deliverables, and models for others to use. Resource Management -Ability to manage one's time within individual, departmental, and corporate goals, and timelines; management of internal and external resources (vendors).

External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Technical - Subject matter expertise and knowledge of applicable lab equipment and operations.

Strong knowledge of analytical techniques including experience using multiple techniques (UPLC/HPLC, GC, Dissolution, MS, NMR, UV, IR, DSC, TGA, Ramen, XRPD, etc.) and advanced experience in at least one technique. Able to interpret results of complex experiments and integrate data produced by other disciplines.

Able to work in lab setting. Proficiency with utilizing typical literature searching techniques to solve organic chemistry problems.

Knowledge of analytical software and data processing platforms. May require 5-10% travel.

More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda Compensation and Benefits Summary: Allowances: Commutation, Housing, Overtime Work etc. Salary Increase: Annually, Bonus Payment: Twice a year Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45 Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year) Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

Flexible Work Styles: Flextime, Telework Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc. Important Notice concerning working conditions: It is possible the job scope may change at the company’s discretion.

It is possible the department and workplace may change at the company’s discretion. Locations Fujisawa, Japan Worker Type Employee Worker Sub-Type Regular Time Type Full time