Boston, United States
Permanent | Full Time
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Specialist/Sr. Specialist, Process Engineering in our Cambridge office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
The Cell Therapy Pharmaceutical Sciences team in Cambridge, MA, is establishing internal capabilities to manufacture several parallel cell therapy programs for in-human clinical studies.
This positions 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 deployed in manufacturing.
In this role you will be expected to work within the GMP Manufacturing Engineering (GME) group, working with Development, Technical Operations and Quality to onboard new processes and instrumentation, and engineer them towards robust deployment and implementation in GMP.
Support process and technology transfers, change management, and technical process support for cell therapy projects
Independently design and execute experiments to support process development
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 groups
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 EBR platform
Support operator training and act as the process engineering 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
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Specialist: Bachelor's degree in life science-related or Engineering discipline with 2.5 years. Master's degree with 1 years in academia, or in biotech/pharma. Industry experience preferred but not required
Senior Specialist: Bachelors degree in life science-related or Engineering discipline with 5+ years relevant industry experience. Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science with 3+ years relevant industry experience
Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a GMP environment
Must be familiar with process qualification/validation requirements, as well as with GMP Change Control requirements.
Knowledge and Skills:
Teamwork Ability to work well in a fast-paced multi-disciplinary environment
Communication - Able to expresses 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
Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
This job posting excludes CO applicants.
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.Boston, MAEmployeeRegularFull time
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