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important to us. Due to the current situation related to the
Coronavirus (COVID-19), we’re leveraging our digital capabilities
to ensure we can continue to recruit top talent at Takeda. As your
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tools to help you through your recruitment journey. If so, one of
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recruitment process. Thank you.
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Every day, employees working in Takeda’s Global Manufacturing
and Supply Chain, and Global Quality business unit are shaping the
future of healthcare. They are breaking down barriers and ensuring
our life-changing medicines are available, accessible, and
affordable to patients. Life-changing for you. Life-changing for
Global Manufacturing and Supply Chain, and Global Quality is the
backbone of Takeda, and our employees are the guardians for our
patients, our products, and our reputation. As a member of our
team, we can offer you the opportunity to grow in a meaningful
career, develop your skills, and come to work every day knowing
that what you do makes a genuine difference.
Success What makes a successful member of our team? Check out
the traits we’re looking for and see if you have the right mix.
Job ID SR0053824 Date posted 09/09/2020 Location Cambridge,
With limited supervision this individual will perform routine
and non routine manufacturing operations, including but not limited
to work functions in Cell Culture, Purification, Solution &
Equipment Prep areas. Operates production equipment according to
SOPs for the production of clinical and/or commercial products.
Will support engineering and validation activities.
Responsibilities: Job Function and Description
Job Function and Description
This individual will carry out cGMP manufacturing operations
utilizing Standard Operating Procedures (SOP), Batch Records and
Form Preps. Responsibilities include
Troubleshoot and resolve process related issues
Create work orders as needed
Initiate and document minor deviations
Execution of critical and routine and non routine production
Informing management of events impacting schedule
Perform Batch Record, Log Book and Form Prep requests
Enter data in the Laboratory Information Management System
Review manufacturing documentation real time to ensure
Coordinate sample preparation and testing
Propose and review document revisions
Carry out work in a safe manner, notifying management of safety
issues and risks
This individual will manage equipment and support facility
related projects by
Act as subject matter expert for improvement projects
Perform scheduled cleaning of equipment
Assembly and disassembly of process equipment
Perform standardization of equipment
Support change over activities
Execution of equipment and process qualifications and
Working with supervision this individual will
Provide technical training for area personnel
Provide input on training material development
Meet and maintain training requirements
Develop and maintain personal development plan
Provide annual performance self assessment
Education and Experience Requirements
Essential: Normally requires a high school diploma and 4-6 years
related industry experience or an Associates Degree in Life
Sciences/Engineering field with 3 years of GMP Manufacturing
Key Skills, Abilities, and Competencies
Substantial understanding of the general and detailed aspects of
the job, and their practical applications to problems and
situations ordinarily encountered.
Will be required to perform as a subject matter expert for
equipment and/or systems
The individual is proficient at following written instruction in
the form of Batch Records, Form Preps, Technical Protocols and
Possess excellent communication and troubleshooting skills.
Full awareness of current Good Manufacturing Practices.
Proficient in Aseptic Technique
Ability to work cohesively in a team environment
Experience with business systems such as ERP, LIMs, and
Will work holidays and overtime as required.
May be required to adjust work schedule to meet production
Proficient in Aseptic Technique
Ability to wear personal protective equipment such as safety
glasses/goggles, gloves and safety shoes.
Ability to gown and gain entry to biotechnology/pharmaceutical
Ability to lift, pull or push equipment requiring up to 25-50
lbs of force.
Ability to stand for 6 hours in a production suite.
Ability to climb ladders and work platforms.
Stooping or bending to check or trouble-shoot equipment
Ability to work around chemicals (alcohols, acids & bases).
Complexity and Problem Solving
Works on assignments that are complex in nature where
considerable judgment and initiative are required in resolving
problems and making decisions
Limited to no supervision / instruction needed for routine task
and minor direction for more complex/no routine tasks.
Clear understanding of manufacturing processes and the ability
to readily identify deviations in process, controls, and guidelines
Will be responsible for identifying, supporting, and
implementing process improvements
Internal and External Contacts
All Internal Manufacturing, Materials Management, Technical
Operations and Facilities Management with limited exposure to
support groups (Validation, Quality Control, Process Development
and Health, Safety & Environment.
May require interaction with equipment, technical and supply
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
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.
EEO is the Law -
EEO is the Law – Supplement -
Pay Transparency Policy -
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.
Job ID SR0053824
Check out where you could be
working if you apply.
Job Seekers: Protect yourself against identity theft Please be
aware there are instances of identity thieves posting
Takeda-branded jobs and posing as employees to steal personal
information. They visit job-related websites and invite candidates
to online chats. During the chat, they press job seekers to provide
bank account information and Social Security numbers.
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