8 days old

Cell Therapy Manufacturing Specialist II

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421
  • Job Code
    R0036058

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Job Description

Title: Cell Therapy Manufacturing Specialist II

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Cell Therapy Manufacturing Specialist II in our Lexington, MA 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.

Primary Duties

The Commercial Cell Therapy Operations team in Lexington, MA is establishing internal capabilities to manufacture and distribute products that provide life changing medicines to patients.

The Cell Therapy Manufacturing Specialist II is responsible for the development, creation, and revision of controlled electronic manufacturing documentation in accordance with cGMP Standards. The Specialist II will lead document authoring while partnering with SMEs from cross-functional teams and is accountable to ensure that all controlled documents being created or revised contain the required information pertaining to process, product, and equipment specifications and are completed within defined timelines. The Specialist II will integrate elements of workplace and human factors into the design and revisions of GMP documentation.

The Cell Therapy MFG Specialist II also leads project activities that pertain to document revisions and/or improvements, including but not limited to CAPA activities in the relevant system. The Specialist will partner with various cross-functional SMEs to execute the scope of document management required for the project while ensuring the on-time completion/closure of the CAPA record.

Responsibilities

% of Time

Job Function and Description

50%

Process GMP documentation in support of Cell Therapy manufacturing operations including:

  • Create and revise SOPs, Electronic Batch Records (MBRs) and Solution Prep Records. Identify and lead required document revisions within the applicable electronic documentation system.
  • Be trained on the MES system pertaining to requirements for authoring and revising electronic batch records / documentation.
  • In accordance with applicable SOPs, ensure consistency and alignment between documents.
  • Address comments as provided by document reviewers and complete the revision process per established timelines.
  • Apply end to end MFG process knowledge when reviewing draft SOPs/MBRs/Solution Prep Records.
  • Ensure that effective human factors principles are applied to documents, software & hardware, and workplace design.
  • Coordinate with the training group to ensure appropriate training materials are created with new or revised GMP documentation.
  • Monitor and trend the effectiveness of document revisions for Cell Therapy. Challenge the system and look for areas of improvement to increase efficiency and decrease document cycle time

25%

Partner with support groups as needed for the timely initiation and completion of activities required to complete Cell Therapy projects, Tech Transfers, or changes to process and systems.

  • Coordinate project resources for the timely initiation and completion of document related activities.
  • Own CAPAs as well as action items in relevant cGMP systems.
  • Complete action items within Trackwise prior to the due date.
  • As applicable, coordinate the scope of document management activities associated with major Cell Therapy projects and manage the associated schedule with the project manager.

15%

Own and manage lower level deviations within the assigned quality system.

  • With the support of cross-functional SMEs, lead the deviation investigation to identify root cause, evaluate impact, and provide recommendations for appropriate corrective and/or preventative actions (CAPA).
  • Investigate undesired outcomes from a systems perspective and ensure that CAPAs address system issues as well as workplace local human factors issues.

10%

Continuous Improvement

  • Monitor and trend the effectiveness of document revisions.
  • Leverage revision process understanding to challenge the system and look for areas of improvement to increase efficiency and decrease document cycle times.
  • Support the development and management of department key performance indicators (KPIs) including trend displays and visual management.

Education and Experience Requirements

Essential:

  • Bachelors degree (or equivalent combination of education and relevant experience) and 3+ years relevant experience in a life sciences-related field.

Desired:

  • Previous technical writing experience preferred
  • Project Management skills and experience preferred

Key Skills, Abilities, and Competencies

  • Excellent communication, technical, organizational, and interpersonal skills are required. Works independently with minimal supervision to execute all facets of assigned tasks and activities.
  • Must be proficient with Microsoft Office applications, including Word, Excel and Power Point. Experience with more advanced document management applications a plus (including but not limited to EDMS and TrackWise).
  • Must be a team player prepared to lead, work effectively and efficiently in a team-based environment.
  • Self-starter that can work in a fast-paced environment and is comfortable with rapid changes in priorities.

Complexity and Problem Solving

  • Support continuous improvement efforts to ensure documentation is efficient and compliant.
  • Work on projects and routine problems of limited complexity and scope while following established policies and procedures.
  • Ensure documents contain accurate details and instructions corresponding with the activity.
  • Ensure that the information contained in documents correspond with the information of related documentation and that they adhere to all GMP requirements.
  • SME of Creation/ Revision process utilizing the electronic documentation system.

Internal and External Contacts

  • Advises, consults, leads, and/or collaborates with cross-functional teams including but not limited to: Manufacturing, Quality Assurance, Quality Control, Facilities and Engineering, Manufacturing Sciences and Technology, Validation, Process/Analytical Development and Environmental, Health, and Safety (EHS).

Other Job Requirements

  • May be required at times to attend department or organization related teambuilding activities and learning events.

This Job Posting excludes CO applicants

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-08 Expires: 2021-07-07
Sponsored by:
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Sponsored by:
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Cell Therapy Manufacturing Specialist II

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421

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