• Job Description

  Req#: R0109490

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  Job Description

  About the role:

  Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Specialist, MSAT, in our Cambridge office.

  The Cell Therapy Manufacturing Team in Cambridge, MA is establishing internal capabilities to manufacture several parallel cell therapy programs for in-human clinical studies. This position’s primary role is to provide scientific and technical input in bringing these programs to patients, with particular focus on qualification and optimization of processes that will be deployed in manufacturing. In this role you will be expected to work within the Manufacturing Science and Analytical Technology (MSAT) Team, working with Development, Technical Operations and Quality to onboard new processes and instrumentation, and engineer them towards robust deployment and implementation in GMP.

  How you will contribute:

  ACCOUNTABILITIES

  • Support process and technology transfers, change management, technical deviation, 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 the changes.
  • Author and execute qualification and validation protocols, working in conjunction with the Technical Operation and Quality Team.
  • Develop and manage tools and templates that can be used to assess impact and criticality for parameters and attributes.
  • Revise and edit master batch records as needed 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 the related Change Control Activities.
  • Assist in the integration and implementation of digital data enterprises, including electronic Batch Record and data systems.

  Minimum Requirements/Qualifications:

  Senior Specialist, MSAT:

  • Bachelor’s degree in biotechnology, biology, engineering or related pharmaceutical science and 3+ years relevant cell processing or aseptic processing experience (preferably 1+ year direct experience working with CAR-T) in Manufacturing or Process Development.
  • Manufacturing or Process Development.
  • Previous hands-on experience in a cGMP or clinically regulated environment is required.
  • Knowledge of aseptic processing in ISO 5 biosafety cabinets strongly preferred.
  • Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines.

  Specialist, MSAT:

  • 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 (direct experience working with CAR-T is preferred) or master’s degree in chemistry, biotechnology, biology, engineering, or related pharmaceutical science.
  • 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.

  Knowledge and Skills:

  • 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.

  PHYSICAL REQUIREMENTS:

  • Work is generally performed in a GMP manufacturing facility and may require extended periods of standing (4 hours)
  • Ability to lift, pull, or push equipment requiring up to 25-50 lbs. of force.
  • Ability to work onsite 5 days a week.
  • Ability to work weekends when necessary.

  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.

  Base Salary Range: $81,900.00 to $117,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

  The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

  Empowering Our People to Shine

  Discover more at takedajobs.com

  No Phone Calls or Recruiters Please.

  #LI-JT1

  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

  Boston, MA

  Worker Type

  Employee

  Worker Sub-Type

  Regular

  Time Type

  Full time

• About the company

  Hope and empathy. These two words are not often associated with pharmaceutical companies. But here at Takeda, our people are motivated to serve patients with integrity, respect, and empathy. Driven by our mission, we seek to bring hope of better health and a brighter future to those we impact. To do this, we focus on our chosen core therapeutic areas: Oncology Gastroenterology Neuroscience Develop life-saving vaccines No matter the region, business unit, function, or team, everyone at Takeda matters. Every one of our employees is a vital contributor to our bold, inspiring mission.

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