Advanced Biotechnology Specialist

7 days ago

Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

Takeda Pharmaceutical is a patient-focused company that inspires and supports careers. We empower our people to realize their potential through life-changing work, being certified as a Global Top Employer. Our company offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace where global teams unite under an unwavering commitment to deliver Better Health and a Brighter Future worldwide.

This role will be a vital contributor to our inspiring mission within the Cell Therapy manufacturing team in Cambridge, MA. The primary goal is to provide scientific and technical input in bringing cell therapy programs to patients, focusing on process qualification and optimization in manufacturing. You will work with Development, Technical Operations, and Quality to onboard new processes and instrumentation, engineering them towards robust deployment and implementation in GMP.

  • SUPPORT PROCESS AND TECHNOLOGY TRANSFERS, CHANGE MANAGEMENT, TECHNICAL DEVATION, AND TECHNICAL PROCESS SUPPORT FOR CELL THERAPY PROJECTS
  • Independently design and execute experiments to support process evaluation and technology transfer
  • Identify aspects required for GMP compliance and perform experiments to validate changes
  • Author and execute qualification and validation protocols, working with the Technical Operation and Quality Team
  • Develop and manage tools and templates to assess impact and criticality of parameters and attributes
  • Revise and edit master batch records using an Electronic Batch Record (EBR) platform
  • SUPPORT OPERATOR TRAINING AND ACT AS THE MANUFACTURING PROCESS SME
  • Author and execute Life Cycle Management process activities and define/coordinate related Change Control Activities
  • Assist in integrating and implementing digital data enterprises, including electronic Batch Records and data systems

The ideal candidate has a Bachelor's degree in biotechnology, biology, engineering or related pharmaceutical science and 1+ years relevant cell processing or aseptic processing experience in Manufacturing or Process Development. Previous hands-on experience in a cGMP or clinically regulated environment is preferred. Knowledge of aseptic processing in ISO 5 biosafety cabinets strongly preferred. Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines, is also highly valued.

REQUIREMENTS:

  • Teamwork - Ability to work well in a highly cross-functional team environment
  • Communication - Able to express oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor
  • Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
  • Organization - Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
  • Motivated - Self-motivated and willing to accept temporary responsibilities outside of initial job description

This role requires extended periods of standing (4 hours), lifting, pulling, or pushing equipment requiring up to 25-50 lbs. of force. You are expected to work onsite 5 days a week and weekends when necessary. For Location: Boston, MA U.S. Base Salary Range: $67,700.00. This role may be eligible for short-term and long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits. 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.

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