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Job Description

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 Scientific Fellow, Drug Product and Device Development where you will provide technical support for the pharmaceutical development of Takeda's pipeline biologics drug products. You will also develop robust formulation for drug substance and drug product throughout their product lifecycle as well as develop/tech transfer of scalable and robust drug product manufacturing process from early phase to process validation. As part of the Drug Product Development team, you will report to Director, Drug Product Development and work with other CMC functions such as Process Teams, Quality, Regulatory and Supply Chain, as well as external contract organizations

How you will contribute:

• Provide technical leadership in execution of biologics product formulation development

• Provide technical leadership for clinical drug product process development / engineering and clinical drug product manufacturing support

• Author/review development documents and support regulatory submissions and responses

• Lead and/or represent within cross functional project teams (process development, tech transfer, and/or CMC teams)

• Identify, evaluate, adopt and develop formulation and drug product technologies to continuously improve business processes and product development capabilities

• Contribute to establishing infrastructure and business processes in support of pharmaceutical development

• Design and execute phase-appropriate DP process development, process characterization, and process validation studies

• Act as Subject Matter Expert (SME) with the DP Process Development, QbD process, and validation strategy in manufacture of Drug Products for biologics compounds

Minimum Requirements/Qualifications:

• Ph.D. in chemistry, biochemistry, and pharmaceutical sciences, or related field with 7 years of relevant experience in pharmaceutical development and drug product manufacturing or M.S. in chemistry, biochemistry, pharmaceutical sciences, or related field with 13 years of relevant experience in pharmaceutical development and drug product manufacturing or Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 15 plus years relevant industry experience.

• Expertise in protein pre-formulation and formulation development, lyophilization, and strong analytical and biophysical characterization skills

• Expertise in aseptic fill/finish manufacturing experience and oversight of CMO operations

• Thorough knowledge of global GMP regulations and guidance

• Experience authoring technical protocols, reports, and CMC sections for regulatory submissions

• Experience working within a project team (preferably involving external partners)

• Experienced and demonstrated track record in biopharmaceutical development including but not limited to biologics formulation development drug product development, drug product process characterization, QbD, control strategy, and process validation.

• Experienced in managing junior staff members

• Good understanding of protein degradation and stabilization strategies applicable to common dosage forms.

• Good understanding of CMC management with involved function areas to drive and meet deliverables in the matrix environment and cross-functional improvements.

• Preferably, experienced in lyophilization and/or combination drug product development with good understanding of the inter-relationship among formulation parameters, process parameters, device performance, product delivery and quality.

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 Work Paths

• 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.

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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