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Manufacturing Lead Associate -Evening shift

Job ID R0043847 Date posted Sep. 03, 2021 Location Cambridge, Massachusetts

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Job Description

Shift: 6:00pm to 6:30am 2-2-3 Pitman schedule

In this role you will be eligible for shift differential 25%. Benefits start the first day of work, company bonus too.

You can continue your education and take advantage of the up to 10K tuition reimbursement opportunity too.

Come join the Manufacturing team as an Associate Team lead working side by side with the supervisor that you report to at this site. This could be a growth opportunity to learn the role of being a supervisor.

The majority of your day will be spent being the primary back up support contact for the manager and you will be troubleshooting and issue resolution or escalation as needed.

  • Create and follow-up on work orders
  • Re-allocate staff as needed during the day (breaks, lunch, training, etc)
  • Oversight and execution of all routine and critical operations as well as commissioning and changeover validation activities
  • Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.)
  • Responsible for floor inventory and communicating schedule changes as needed
  • Monitor material consumption and coordinate all materials deliveries
  • Recommend/Implement process changes/improvements or safety/ergonomic improvements.
  • Ensure work is carried out in a safe manner, notifying management of safety issues and risks

People responsibilities in this role will include:

  • Responsible for interviewing candidates that report to the Manager
  • Provide timely feedback on staff’s performance
  • Address minor personnel issues timely
  • Escalate major personnel issue to the supervisor
  • Ensure staff compliance with all relevant documentation and safety guidelines
  • Act as a role model (Lead by Example)
  • Act as a resource/SME for staff
  • Ensure the use of safe work practices and behaviors


  • Conduct training and assess effectiveness
  • Help identify training needs
  • Assess staff skill sets and provide feedback to Supervisor.
  • Develop training material
  • Provide training


  • Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause
  • Implement appropriate corrective actions
  • Complete action items for GMP investigations and CAPA’s
  • Assist supervisor/engineer/facilities with investigations
  • Revise and author GMP documentation 
  • Communicate any quality issues/concerns to Supervisor and QA

Education and Experience Requirements

Requires a high school diploma or GED and 6+ years related industry experience or an Associate’s Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience. College degree a big plus.


Biotech Certificate and prior leadership experience preferred. Experience with systems such as SAP, LIMS and TrackWise is a plus

Key Skills, Abilities, and Competencies

         Proficient in aseptic technique

  • Operational knowledge of Systems and general equipment 
  • Knowledge of cGMP’s and applicable agency regulations (such as the FDA, EMA) to ensure inspection readiness of department.
  • Effectively communicate to all levels throughout the organization
  • Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
  • Self-motivated individual with the ability to complete and manage multiple floor activities in an effective and compliant manner.  In the absence of the supervisor they are the person of authority.
  • Expected to act on behalf of the supervisor while on the floor
  • Flexibility to work according to the production schedule. This position will require weekend, holiday and overtime work at times.
  • Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes. and gain entry to biotechnology/pharmaceutical manufacturing areas.
  • Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force and stand for up to 6 hours in a production suite.
  • Ability to climb ladders and work platforms as well as able to do stooping , bending to check or trouble-shoot equipment operations while working around chemicals (alcohols, acids & bases).      

Complexity and Problem Solving

  • The incumbent will be responsible for technical problem solving and recommending efficiency and/or operational improvements.
  • Required to make process decisions, with the help of supervision and support roles, including the trouble shooting of equipment, corrective action to process deviations.
  • Individual will be required to understand operations and contact appropriate support to ensure issues are appropriately resolved.

This Job Post excludes CO Applicants


EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.


USA - MA - Alewife - BIO OPS

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Time Type

Full time