GMP Documentation and Training Lead, Cell Therapy
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GMP Documentation and Training Lead, Cell TherapyApply Now
As a GMP Documentation and Training Lead, working on the Cell Therapy GMP Operations team, you will be empowered to support the manufacturing of Takeda’s Cell Therapy products and work with cross-functional peers to support clean room activities. The primary focus of the GMP Documentation and Training Lead role will be supporting cGMP cell therapy manufacturing at Takeda’s new cell processing facility in Cambridge, Massachusetts. This position will directly contribute to the successful delivery of novel cell products in support of human clinical trials.
Lead activities to create new or revise existing manufacturing documents such as Batch Records, SOPs, On the Job Training forms
Leads and/or supports continuous improvement projects for Manufacturing Batch Records, SOPs or training records
Supports data gathering and entry as needed to support GMP manufacturing
Coordinates issuance of all manufacturing batch records or associated documentation for execution
Maintain all manufacturing records in a secure and compliant manner. This includes executed batch records, validation records or log books.
Coordinate GMP training program to assure that all manufacturing employees performing GMP-related tasks receive GMP training, as is necessary to comply with cGMP written policies and procedures.
Ensure all training assignments are complete and up to date, to maintain necessary technical skills and knowledge
Support investigations in manufacturing GDP deviations
Actively participate in problem identification, problem solving, and change initiatives in cooperation with other teams and functions
EDUCATION, EXPERIENCE AND SKILLS:
Bachelors degree in biotechnology, biology, engineering or related pharmaceutical science and 5+ years relevant GMP documentation experience in Manufacturing.
Masters degree in chemistry, biotechnology, biology, engineering or related pharmaceutical science and 3+ years relevant GMP documentation experience in Manufacturing or Process Development.
Previous hands-on experience in a cGMP or clinically regulated environment is required.
Previous experience with electronic based Quality Management Systems is preferred
Manufacturing experience in biopharmaceutical operations, preferably involving Cell or Gene Therapies.
Knowledge and Skills:
Teamwork – Ability to work well in a fast-paced multi-disciplinary environment
Communication - Able to express one’s self 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
Requires weekend and holiday support per schedule
Must be able to achieve and maintain annual aseptic gowning qualifications
May require approximately 10% travel.
This job posting excludes CO applicants.
Time TypeFull time
Job ID R0031511