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Cell Therapy Sr. Manufacturing Associate

Lexington, Massachusetts

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Cell Therapy Sr. Manufacturing Associate

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Job ID R0036456 Date posted 06/02/2021 Location Lexington, Massachusetts

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Job Description

Cell Therapy Sr. Manufacturing Associate

This position reports to days Monday- Friday, standard business hours.

Primary Duties

Serve as manufacturing associate responsible for performing and supporting all cell therapy manufacturing operations. The Sr.  Manufacturing Associate is responsible for the reliable manufacturing of cell therapy drug product through focus on safety, rigorous cGMP practices, and adherence to the production schedule. 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. Plays an active role in process and procedural development and improvement.

Responsibilities:

Percentage of Time

90% Processing:

  • 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 consumption, sampling,
  •  Required 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
  • Escalate issues and ensure prompt follow through to support resolution
  • Ensure documentation (electronic batch records, log books, sample requests etc.) is complete, reviewed and meets good documentation practices

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  
  • Education and Experience Requirements

Minimum Requirements:

  • Bachelors degree in a biological science or engineering discipline or industry experience
  • 2+ years of cGMP industry experience
  • Experience with aseptic processing and cell culture manufacturing
  • Desired:
  • 3-5 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
  • Key Skills, Abilities, and Competencies
  • 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
  • Ability to 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 guidance to support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations
  • Demonstrated application in practical root cause analysis methodologies

Internal and External Contacts

  • Advises, consults and collaborates with cross-functional teams including but not limited to: Facilities and Engineering, Manufacturing Sciences and Operations Support, Quality, Validation, PMO Process Development and Health, Safety & Environment.

Other Job Requirements

  • Requires weekend and holiday support per schedule
  • Must be able to achieve and maintain annual aseptic gowning qualifications
  • Must be able to lift, pull or push equipment requiring up to 25-50 lbs. of force
  • Please be aware that this position is considered “Essential Personnel.”  This means that in the case of inclement weather (e.g. snow storm) 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 Shire 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.

This position excludes CO applicants

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0036456
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