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Cell Therapy Manufacturing Lead

Lexington, Massachusetts

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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 patients.

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Cell Therapy Manufacturing Lead

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Job ID R0030347 Date posted 04/20/2021 Location Lexington, Massachusetts

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Job Description

The Cell Therapy Manufacturing Lead is responsible for all cell therapy manufacturing operations and for the reliable manufacturing of cell therapy drug product through active leadership, focus on safety, rigorous cGMP practices, and adherence to the production schedule.  

As the Cell Therapy Manufacturing Lead, you will:

  • Provide on the floor leadership to the manufacturing team and serves as process and equipment subject matter expert 

  • Implements and maintains manufacturing processes for new and/or existing products and technologies in a cGMP environment

  • Collaborate with support groups to ensure accurate and well managed transfer of process and any new changes/improvements to floor operations

  • Integrate best practices, where appropriate, into manufacturing

  • Cultivates team’s psychological safety, making team feel safe to be candid about their work environment and to raise difficult issues that enables the organization to improve

  • Continually seeks improvement by encouraging team members to escalate, regardless of the significance, safety, compliance, and manufacturing issues from the floor to management to improve safety, reliability, and quality

  • Play an active role in process and procedural development and improvement. 

Other Responsibilities:     

80% - Processing:

  • Primary shop floor manufacturing contact and SME for manufacturing process and equipment

  • Ensure prompt follow through for corrections of problems and flawed systems or processes

  • Primary cell therapy manufacturing operator capable of performing all cell therapy manufacturing operation (cell separation, transduction, cell expansion) in an aseptic environment   

  • Responsible for daily operations on the production floor including training, material use and troubleshooting to ensure that all operations are in full compliance with applicable GMP documentation and safety guidelines

  • Develop technical expertise in area of Cell Therapy Manufacturing and provide technical instruction on new/improved processes to appropriate audiences

  • Create, review and revise manufacturing procedures and electronic production records

  • Implement process change, safety, and ergonomic improvements

  • Partner with OE, and champion continuous improvement within designated area

  • Support tech transfers as required

  • Ensure documentation (electronic batch records, logbooks, sample requests etc.) is complete, reviewed and meets good documentation practices

  • Act as supervisor delegate when required

10% - People:

  • Responsible for interviewing and selecting candidates

  • Recognize and appreciate employee contributions and support workforce diversity

  • Ensure that employees are working in a safe and compliant manner                  

  • Help drive support and change management

Training

  • Serve as SME for training documentation generation, approval, and review

  • Sever as qualified trainer to support training of additional staff

  • Provide coaching to manufacturing team on safety, GMP and processing operation to ensure safety and compliance

10% - Quality:

  • Initiate deviations or investigations of various complexities and work with cross-functional departments to evaluate root cause, and implement appropriate corrective actions

  • Provide technical expertise to resolve manufacturing issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs, product licenses and corporate policies

  • Revise, author, and review GMP documentation  

  • Ensure operational metrics and business systems are maintained

Education and Experience Requirements

Minimum Requirements:

  • Bachelor’s degree in a biological science or engineering discipline or industry experience

  • 3+ years of cGMP industry experience

  • Experience with aseptic processing and cell culture manufacturing

Desired:

  • Master’s degree in a biological science or engineering

  • 4-5 years related cGMP industry experience

  • Experience with cell therapy (viral vectors, transduction, cell separation etc.)

  • Experience with systems such as SAP, LIMS and TrackWise, MES is a plus

  • Experience with DP fill finish

  • Knowledge of universal precautions for handling human derived materials within a BSL-2 environment

  • Experience with cryopreservation processes and equipment

Other Job Requirements

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

  • Requires weekend and holiday support per schedule

Key Skills, Abilities, and Competencies

  • Must possess effective leadership skills

  • Operational knowledge of systems and equipment 

  • Knowledge of cGMP’s and applicable agency regulations (such as the FDA, EMA) to ensure inspection readiness of department

  • Good interpersonal skills and ability to work in a team environment

  • Effectively communicate to all levels of the organization  

  • Proven organizational and time management skills

  • Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure

  • Strong attention to detail and ability to recognize, report and resolve potential problems

  • Complexity and Problem Solving 

  • Responsible for technical problem solving, operational improvements, and efficiency improvements

  • Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations.

  • Demonstrated application in practical root cause analysis methodologies

Location and Salary Information:

Cambridge, MA + Lexington, MA
Base Salary Range: $58k- 87k based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off

Please be aware that this position is considered “Essential Personnel.”  This means that in the case of inclement weather (e.g. snowstorm) the employee who occupies this position may be expected to report to work for their normal shift if management deems necessary.   To ensure “Essential Personnel” are safe during inclement weather situations Takeda may provide lodging, shuttle service, and food (depending on the severity and duration of the inclement weather event).  These details will be provided by management prior to any potential inclement weather situation.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0030347
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