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Takeda Pharmaceuticals Sr. Scientist in Lexington, Massachusetts

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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 a Sr. Scientist where you will be involved in pharmaceutical development of Takeda's biologics products (including mAbs, recombinant proteins, peptides, and ADCs) and combination products. Responsibilities include development of robust liquid or lyophilized formulation for drug substance and drug product throughout the product lifecycle as well as development/tech transfer of scalable and robust drug product manufacturing process from early phase to process validation. You will also provide leadership and technical guidance for formulation and drug product development efforts, author technical protocols, design and implement experiments, generate technical reports, and author related CMC sections to support regulatory submissions. As part of the Drug Product and Device Development team, you will report to Director, Drug Product Development and work with Process Development and CMC team members including technical services, drug substance process development, analytical development, quality control, quality assurance, and supplier relationship leads.

How you will contribute:

  • Identify potential issues, develop solutions to technical challenges, and influence stakeholders across the development organization to keep projects on schedule.

  • Provide technical leadership in execution of biologics product formulation development studies. Design and execute phase-appropriate DP formulation development, process development, and process characterization studies (60%)

  • Provide technical leadership for clinical drug product process development and clinical drug product manufacturing (15%)

  • Author/review development documents and support regulatory submissions and responses (5% or per need basis)

  • Identify, evaluate, adopt, and develop formulation and drug product technologies to improve product development capabilities (15%)

  • Support drug product manufacturing deviation investigations, CAPAs, and change control management (5%)

Minimum Requirements/Qualifications:

  • Ph.D. in chemistry, biochemistry, and pharmaceutical sciences, or related field with 3 years of relevant experience in pharmaceutical development and drug product manufacturing

  • M.S. in chemistry, biochemistry, pharmaceutical sciences, or related field with 9 years of relevant experience in pharmaceutical development and drug product manufacturing

  • Bachelors degree in chemistry, biochemistry, pharmaceutical sciences, or related field with 11+ years relevant industry experience

  • Expertise in liquid and lyophilized protein formulation development and aseptic fill/finish manufacturing development/ oversight

  • Experience in conducting analytical and biophysical methodologies such as HPLC-based assays and biophysical-based characterization

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

  • Experience working within a project team

  • Experienced and demonstrated track record in biopharmaceutical product development including drug product development, drug product process characterization, QbD, and control strategy

  • Experience with protein degradation, stabilization strategies, cGMP, and ICH guidelines applicable to formulation development of Biologics

  • Experience with CMC management with involved function areas to lead and meet deliverables in the cross-functional teams

  • Experienced in lyophilization and combination drug product development with an understanding of the inter-relationship among formulation parameters, process parameters, 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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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