Sr Scientist - Biologics Drug Product Development

Company: Takeda Pharmaceutical
Location: Dracut
Posted on: September 22, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 - Biologics Drug Product Development where you will be involved in the pharmaceutical development of Takeda's biologics products (including mAbs, recombinant proteins, peptides, and ADCs). You will also be involved in development of formulation for drug substance and drug product throughout their product lifecycle and development/tech transfer of scalable drug product manufacturing process from early phase to process validation. You will provide leadership and technical guidance for formulation and drug product development efforts, author technical protocols, design and implement experimentation, create technical reports, and author related CMC sections to support regulatory submissions. As part of the DPD Biologics, 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 and manufacturing leads. You will also work with 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
• Represent drug product development within project teams, organizational initiatives, and technology development groups
• Identify, evaluate, adopt and develop formulation and drug product technologies to improve business processes and product development capabilities
• Design and execute phase-appropriate DP formulation development, process development, process characterization, and process validation studies.
• Support drug product manufacturing deviation investigations, CAPAs, and change control management.
• Identify potential issues, develop solutions to technical challenges, and influence stakeholders across the development organization to keep projects on schedule. Minimum Requirements/Qualifications:
  • Minimum, Ph.D. in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field with 3 years of relevant experience in pharmaceutical development and drug product manufacturing or M.S. in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field with 8 years of relevant experience in pharmaceutical development and drug product manufacturing.
  • Expertise in protein formulation development and aseptic fill/finish manufacturing development/oversight
  • 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 drug product development, drug product process characterization, QbD, control strategy, and validation
  • Experience with protein degradation and stabilization strategies applicable to common dosage forms.
  • Experience with CMC management with involved function areas to lead and meet deliverables in the matrix environment and cross-functional improvements.
  • Preferably, experienced in lyophilization and combination drug product development with a 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. 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

Keywords: Takeda Pharmaceutical, Lowell , Sr Scientist - Biologics Drug Product Development, Other , Dracut, Massachusetts