Manufacturing Associate at Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts

Job Description:

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Job Description

This position reports to Nights, 6:00pm – 6:30am, 2-2-3, 12.5 hours shift, off every alternate weekend. Due to business need, on select occasions, employees may be required to work overtime.

With direct supervision this individual will perform routine manufacturing operations to produce clinical and/or commercial products.  Operates production equipment according to SOPs in their assigned areas.

Primary responsibilities include:

80%

The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include

• Execution of routine production operations


• Perform Batch Record and Form Prep requests


• Enter data in the Laboratory Information Management System (LIMS)


• Record data into logbooks


• Sample preparation and testing


• Propose document revisions


• Complete required training on time


• Carry out work in a safe manner, notifying management of safety issues and risks

10%

The individual will manage equipment and support facility related projects by

• Initiating work orders


• Perform scheduled cleaning of equipment


• Perform standardization of equipment


• Support change over activities


• Assist in the assembly and disassembly of process equipment

10%

Staff Technical Training and Development

• Meet and maintain training requirements


• Develop and maintain personal development plan


• Provide annual performance self-assessment on development plan

Education and Experience Requirements

Minimum

• High School Diploma or an Associate’s Degree in Life Sciences/Engineering field


• 0-2 years related industry experience

Preferred

• Biotech Certificate

Key Skills, Abilities, and Competencies

• The individual should have the ability to perform functions such as: Following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures


• Possess excellent communication and troubleshooting skills


• Familiar with current Good Manufacturing Practices


• Basic documentation and computer skills


• Will work holidays and overtime as required


• May be required to adjust work schedule to meet production demands


• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes


• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas


• 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 operations


• Ability to work around chemicals (alcohols, acids & bases)

Complexity and Problem Solving

• Receives assignments in the form of objectives with goals and process to meet goals outlined


• Work is reviewed by supervisor to measure meeting of objectives


• Accomplishes tasks mainly through direct operation of cGMP activities


• Performs daily operations of the work unit and actively assists coworkers in fulfilling department goals elevating issues to senior staff

Locations

Worker Type

Worker Sub-Type

Time Type

Full time