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Job Description

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 a Senior Scientist, Process Analytics  where you will support process chemistry and engineering through expertise in off-line analytical method development, to enable route scouting, reaction optimization and mechanistic understanding for synthetic molecules. You will also identify and plan both project-related and scientific technical objectives and initiate processes to achieve these goals. Your work also involves developing significant technical strategies and serving as a technical resource within the department for analytical challenges. You will coordinate project transfers as needed, recommend appropriate vendors, and work with cross-functional teams to address scientific challenges. As part of the Process Analytics (PA) Group for Synthetic Molecule (SM) Process Development (Drug Substance), you will report to Head, Process Chemistry, 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 (in collaboration with Analytical Development).

• Collaborate with drug substance process chemistry and engineering to design and execute experiments for route scouting, 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 dentification 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.

• 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.

• Technology advancement: work cross-functionally to ensure continued innovation for the PA team.

• Platform consolidation of analytical data so that chemists and engineers can easily access data, accelerate processing time, and integrate results.

• Contribute significantly 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; provide training/mentoring for junior staff.

• Define more complex/novel approaches and methodologies to solving complex technical challenges.

• Proactively identify vendors and build relationships to gain access to technologies as needed to deliver pipeline goals.

Minimum Requirements/Qualifications:

• Bachelor's degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years relevant industry experience.

• Master's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 9+ years relevant industry experience.

• PhD in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 3+ years relevant industry experience.

• Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients.

• Previous experience with the use of contract facilities desired.

• Experience in working in a multi-disciplinary team environment.

• Strong background in analytical chemistry or organic chemistry, and reaction kinetics is essential, along with the ability to work collaboratively with cross-functional teams to ensure the successful development of synthetic drug substance processes.

• Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and workable solutions.

• Teamwork - Ability to work well on global cross-functional teams; Proven ability to foster a highly efficient team environment.

• Communication Skills - Ability to expresses 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.

• Organization - Exercises suitable time management and prioritization skills to balance several 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 works with external vendors for projects.

• Leadership Skills: Demonstrated ability to manage the organization; Ability to use appropriate management strategies to provide direction for team members' work and support individual development.

• 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 fields a plus.

• Experience with data 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.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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