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Staff Engineer- Biologics Process Development (Purification Focus)

Company: Takeda Pharmaceutical
Location: West Roxbury
Posted on: August 7, 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 Staff Engineer / Senior Staff Engineer - Biologics Process Development (Purification Focus) where you will be an important contributor within a group responsible for upstream and downstream process development. Provide theoretical/conceptual input to the design and development of research assignments for a specific project or projects within the functional area. You will also execute most unit operation characterization and optimization experiments within expertise and develop an awareness of unit operations in other areas. As part of the Process Development team, you will report to Director, Process Development. How you will contribute:

  • Manage sole technical leadership within project or complex study.
  • Prepare technology transfer documentation, regulatory documents, and validation plans and reports or coordinate with team members to ensure execution.
  • Small-scale experiments, scale-up, technology transfer and support for programs that bring new bio-pharmaceutical products to pre-clinical, clinical and commercial manufacturing phases.
  • Design and perform experiments for purification process development, optimization and characterization studies for therapeutic proteins. The scope includes IND- and BLA-enabling studies and preparation of regulatory submissions. The experimental studies involve both lab scale and pilot plant runs, including toxicology, clinical and validation batches.
  • Represent line functions on CMC teams.
  • Identify process or study challenges and proposes potential resolutions.
  • Identify and recommend vendors.
  • Lead interns/co-ops and potential future contractors.
  • Develop and leverage strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions across CMC and other development tasks.
  • The role reviews, communicates data cross functionally within CMC and project teams.
  • Coordinate with others in creating technical reports including reviewing and editing.
  • Conduct analysis of technical and conceptual risk and trends.
  • Recognized as a technical expert and resource within function.
  • Identify topics for initiatives and lead local/global projects as directed by senior staff. Minimum Requirements/Qualifications:
    • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0-3 years relevant industry experience
    • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6-10 years relevant industry experience
    • Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8-12 years relevant industry experience
    • Experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP's
    • Sound knowledge of current Good Manufacturing Practices (cGMP)
    • Previous experience with the use of contract facilities
    • Experience working in a multi-disciplinary team environment
    • Previous experience contributing to regulatory filings
    • Experience on phase-appropriate purification process development and associated unit operations.
    • Experience in design of experiments, process monitoring, process risk assessment, statistical analysis and the ability of interpreting data and deriving conclusions. 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, Boston , Staff Engineer- Biologics Process Development (Purification Focus), Engineering , West Roxbury, Massachusetts

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