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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 an Associate Director, 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 also oversee staff, holding responsibility for team performance and outcomes, with the authority to allocate area resources to project teams. 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 Chemistry, 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.

• Contribute significantly to develop, drive, and set the vision and direction of departmental process analytics activities, management of resources, time, and personnel.

• Manage aspects of department performance, and effective communication within the group and across pharmaceutical sciences.

• Communicate with senior management of other functions on the implementation of infrastructure, technology, work processes, or business processes.

• 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 direct reports.

• Contribute to cross-departmental strategy.

• Initiate or endorses complex projects with extraordinary technical challenges and applies broad technical risk assessment skills.

Minimum Requirements/Qualifications:

• 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 with direct accountability for managing a team of direct reports.

• 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 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 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 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 field a plus.

• May require approximately 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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