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 Material Qualification Specialist where you will support all Pharmaceutical Sciences therapeutic development projects globally and a global Material lifecycle management program for internal and external Material Qualification efforts. You will also contribute to the global Material Qualification strategy and knowledge management in PharmSci and to the Material Qualification continuous improvement solutions within the MQ team and in working with PharmSci SMEs. As part of the Operations and Partnerships group in Pharmaceutical Sciences, you will report to Material Qualification Lead.

How you will contribute:

• Support global PharmSci (internal and external) as SME, providing project technical and MQ expertise.

• Collaborate with the Global Manufacturing and Supply MQ team and align on MQ work packages for late phase clinical therapeutic programs.

• Align with Reg CMC on MQ requirements for filings and stay informed about changes in regulatory filing requirements for MQ studies.

• Represent the PharmSci global perspective on Material Qualification efforts in wider, cross-functional teams and forums.

• Work with the team lead to analyze publicly available business intelligence to identify business trends, opportunities and requirements in material selection, implementation, and qualification.

• Analyze unstructured problems, identify root causes and align team objectives to drive function and Pharm Sci goals.

• Use agile principles to reduce process complexity and increase organizational capacity.

• Use business analytics to identify new opportunities and capability needs for PharmSci.

• Ability to support the global business across multiple time zones with some domestic and international travel to support projects.

Minimum Requirements/Qualifications:

• BS/MS/PhD degree in a Science or Engineering or related discipline with 4-6 years of experience working within bio/pharmaceutical development, manufacturing or related field.

• Six Sigma or related certification is a plus.

• Strong knowledge of pharmaceutical development, manufacturing operations, and product quality.

• Experience in Microsoft tools (Excel, SharePoint, etc.)

• Background in material sciences, analytical chemistry or material qualifications (including Extractables and Leachables (E&L) studies) is preferred.

• Collaborative work experience in biotechnology or pharma: QC, Analytical Development, Drug process, Process development, or Engineering is necessary.

• Knowledge of Project Management and Process Improvement methodologies (DMAIC/Six Sigma, 3S, etc) is a plus.

• Knowledge of essential CMC activities and regulatory filing strategies.

• May require approximately up to 5% travel.

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.

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

Base Salary Range: $87,500 to $125,000, 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.

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

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