Posted to MedZilla on 5/21/2019

Takeda Pharmaceuticals

US-MA, Team Lead Stability Management SR0033250-MZ


Primary Role:

This Management position as a Stability Portfolio Lead in the Global QC Stability Department includes

  • Leading a team responsible for Management of Stability Studies of Biotechnological Products and Small Molecules
  • Ensuring a regulatory compliant GMP Stability Study program for the assigned product portfolio
  • Leading and Developing Associates including Performance Reviews, Setting of Goals, Development plans and Leading of staff meetings
  • Organization of work within the area of responsibility


  • Provides Guidance and Ensures GMP Compliance and Setting of Standards for the Development of Stability Study Designs, Stability Study Documentation, Processes and Statistical Data Evaluation
  • Generation, Review and Approval of SOPs, Stability Protocols and Reports
  • Generation of Stability Sections for Submissions and Responses to Health Authorities
  • Representation of the department during internal and external Audits and Inspections
  • Provides Guidance to subordinates or staff members to meet schedules, conduct and resolve investigations and quality related events
  • Provides direction in conjunction with department head to continue to develop the area(s) technical and compliance capability along with long term strategic planning in both personnel and technical abilities
  • Administers budgets, schedules, and performance metrics
  • Driving Projects for organizational Integration and Continuous Improvement
  • Implementation of Global Standards and Processes for Stability Study Management

Education & Experience Requirements:

Typically requires a scientific degree and a minimum of 10 years of experience in the pharmaceutical industry (a science related degree is preferred)

Additional Specific Experience

  • Strong and effective people management skills
  • Excellent communication, interpersonal and organizational skills.
  • Strong knowledge of GMP regulations
  • Ability to work in Global Teams
  • Ability to work well both independently and in a team environment.
  • Excellent Technical writing and Presentation skills
  • Ability to prioritize work and multitask.

Other Requirements:

  • Some travel expected; although not routine. Travel between sites may be required.

The following physical abilities are required in order to fulfill the job duties:

  • Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
  • Ability to work around chemicals (if working around the laboratories)
  • Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
  • Ability to walk and stand for periods of time

Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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