Head PDT Drug Product Development

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Job Description

Head PDT Drug Product Development

Takeda PharmaceuticalUSA - MA - LexingtonAbout the role:

The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases.Takeda believes there is tremendous potential to do more to meet patients' and health care providers expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases.This is a new R&D organization, and the incoming leader will have the ability to create and define the future vision and operating model for the team.Join Takeda as a Head PDT Drug Product Development where you will responsible for driving new, innovative methods supporting programs to develop and improve the drug product quality of plasma-derived therapies, optimized for patients for globally and locally. This includes development activities at the Vienna site and in collaboration with CROs for development of formulations, container systems and finally methods for compatibility testing and of final drug products. You will report to Head of PDT PharmSci .

How you will contribute:

PDT R&D focuses first and foremost on developing therapies that will improve the health care outcomes of patients Takeda aims to serve. The Head of PDT Drug Development will be accountable for:

• Co-ordinating new projects, preparing technical proposals addressing their needs and drawing up cost estimates

• Plan, co-ordinate, and oversee the work activities of scientific staff within the different groups

• Supporting drug product process development work at internal and external labs

• Planning and executing lab-scale and at-scale process development and characterization studies

• Serving as subject matter expert on technology transfer and cross functional teams

• Executing risk assessments and preparing process control strategies

• Presenting scientific data to technical teams

• Ensure fundamental engineering principles are applied to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches

• Establish internal capabilities for plasma protein related formulation and drug product development and hire a best-in-class team to design and execute phase-appropriate development activities for PDT products in mid to late stage development and up to commercial registration

• Responsible for all scientific, strategic, and project planning and execution aspects of PDT formulation development, drug product process development, primary packaging development, technology transfer, scale-up, and validation activities, based on organizational goals and project timelines

• Liaises with other R&D functions on critical joint projects

• Drives team to honor timelines & deliverables

• Execute budget responsibility for the teams including OPEX and CAPEX budget planning and controlling. Complement internal resources by a smart sourcing strategy.

Minimum Requirements/Qualifications:

• The incoming leader must be comfortable with working in a fast-paced environment and comfortable with ambiguity.

• Must show examples of strong leadership and collaboration with multi-disciplinary teams.

• 10+ years of Pharm Sci pharmaceutical/ biotechnology industry experience is required.

• Successful track record of developing employees and team members is critical.

• Advanced degree (PhD or MD (or equivalent)) is required.

• Experience executing formulation, stability, and product characterization studies.

• Demonstrated track record of successful formulation and drug product development, supporting clinical/commercial programs for recombinant protein products, including filing of INDs/IMPDs and BLAs.

• Deep technical understanding of all aspects pertaining formulation and drug product development of liquid and lyophilized biological products, including experience with multiple primary packaging configurations and combination products.

• The ideal candidate will also have proven experience with contract manufacturing organizations including establishing and managing clinical supply agreements.

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.

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

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time