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GMP Documentation and Training Lead, Cell Therapy

Boston, Massachusetts

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Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.

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GMP Documentation and Training Lead, Cell Therapy

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Job ID R0031511 Date posted 06/02/2021 Location Boston, Massachusetts

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Job Description

OBJECTIVE:

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.

ACCOUNTABILITIES:

  • 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:

Required:

  • 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

PHYSICAL DEMANDS:

  • Requires weekend and holiday support per schedule

  • Must be able to achieve and maintain annual aseptic gowning qualifications

TRAVEL REQUIREMENTS:

  • May require approximately 10% travel.

#LI-KD1

This job posting excludes CO applicants.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0031511
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