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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 three 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 Scientific Fellow where you will be responsible for providing leadership and technical expertise to SM-DPD formulation and manufacturing process development for Takeda pipeline compounds. You will also be responsible for planning and execution of drug product development activities including Formulation / Manufacturing Process Development, Tech Transfer, Clinical Manufacturing, Process Validation and supports Regulatory Filing. As part of the Drug Product Development, you will report to Director, Product Development.

How you will contribute:

• Subject Matter Expert (SME) on Oral Solid Dosage (OSD) development and manufacturing, and will represent SM-DPD group in cross functional PST/CMC teams and use your DP expertise to communicate data/strategy to the cross functional teams.

• Design, execute, and/or manage drug product development programs for all Takeda pipeline compounds, including modalities such as Small Molecules, Proteins/Peptides and Biologics, with special focus on Oral Solid Dosage formulation / manufacturing process development.

• Manage the development of Oral Solid Dosage form drug product formulation and manufacturing activities with Takeda internal resources and external contractors.

• Responsible for drug product manufacturing activities at CDMO’s including master batch records, protocols for GMP manufacturing, batch release, deviations, investigations, CAPA’s and change controls.

• Manage complex problems or issues arising during development programs: plans, negotiates and/or implements additional studies or activities needed to resolve scientific or business issues.

• Prepare/Review pharmaceutical development summaries for INDs, IMPDs, NDAs, MAAs and other global regulatory submissions on all Takeda pipeline compounds. Critically reviews and evaluates assigned pharmaceutical development reports from external vendors. Ensure the scientific integrity and quality of all the data, as well as the appropriate interpretation of experimental results, and the adequacy of the final report.

• Participate in the review of New Product Due Diligence opportunities, including an overall assessment of the compound/technology, in support of business development activities. Conduct appropriate literature reviews.

• Serve as global liaison with other functional areas and project teams within Takeda. Works with personnel from Takeda, partner companies, consultants and/or external service providers to meet the goals of Takeda development programs and to ensure the scientific integrity, quality, timeliness, and cost effectiveness of drug development program.

Minimum Requirements/Qualifications:

• Must have a degree in a related scientific discipline. BS with at least 15 years, MS/PharmD with at least 12 years or a PhD with 7 years of experience in Product Development in the Pharmaceutical industry

• Experience and demonstrated track record in several drug product development activities such as early phase formulation development, formulation characterization, manufacturing process development, tech transfer, scale up and process validation. Prior experiences in OSD continuous manufacturing is preferred.

• In-depth technical expertise in development and manufacture of Oral solid dosage forms with demonstrated experience in one or more formulation techniques including but not limited to solubilization, spray drying, hot melt extrusion, nanoparticles, dry/wet granulation, tablet compression, Wurster process, tablet coating, and encapsulation. Parenteral formulation development and manufacturing (fill/finish and aseptic processing, lyophilization) experience is a plus.

• Experience of clinical supply manufacturing requirements and regulations.

• Experience of early and late-stage development including product stability, device development and packaging / labeling requirements.

• Experience in multiple major regulatory submissions and interacting with FDA or European Regulatory Authorities.

• Understanding of drug development and the NDA submission process including excellent knowledge of managing CMC aspects (drug substance manufacturing, formulation, analytical chemistry, and CMC compliance).

• Scientific report writing, reviewing and editing experience required.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Ways of Working

• Tuition reimbursement

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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $143,500 to $205,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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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