Manufacturing Associate II

Takeda•Lexington, MA

2d•Onsite

About The Position

As a Manufacturing Associate II at Takeda, you will perform routine and critical manufacturing operations in Cell Culture, Purification, and Solution & Equipment Prep. You will operate production equipment according to standard operating procedures to produce clinical and commercial products. The role works a 2-2-3 rotating shift, with working hours from 6:00 AM to 6:30 PM. This position is considered essential personnel. During inclement weather, you may be expected to report for your normal shift if management deems it necessary. Depending on the severity and duration of the weather event, Takeda may provide lodging, shuttle service, and food; management will provide details beforehand. The role is based at Takeda’s BIO OPS location in Lexington, Massachusetts. The work environment may include controlled production areas requiring special gowning and protective clothing, cold and wet conditions, loud areas, and exposure to chemicals. The position may require supplemental hours and work on multiple shifts, including weekends.

Requirements

High school diploma and 2–4 years of related industry experience, or an Associate’s Degree in a Life Sciences or Engineering field.
Proficiency in aseptic technique.
Proficiency in following written instructions, including Batch Records, Form Preps, technical protocols, and procedures.
Full awareness of current Good Manufacturing Practices (GMP).
Proficient computer skills.
May be required to perform as a subject matter expert for equipment and/or systems.
Ability to work a 2-2-3 rotating shift, with hours from 6:00 AM to 6:30 PM.
Ability to work multiple shifts, including weekends, and supplemental hours as necessary.
Ability to stand for six hours in a production suite, climb ladders and work platforms, and stoop or bend to check or troubleshoot equipment.
Ability to lift, pull, or push equipment requiring up to 25–50 pounds of force.
Ability to comply with manufacturing-area gowning and personal-item restrictions, and to use respiratory protection or additional hearing protection when required.

Nice To Haves

Biotech Certificate.

Responsibilities

Troubleshoot and resolve basic process-related issues.
Recognize and escalate deviations.
Implement critical and routine activities to support production.
Perform Batch Record, Log Book, and Form Prep requests.
Enter data in LIMS, MODA, and other systems.
Review GMP documentation.
Prepare and test samples.
Identify changes needed to documentation.
Participate in the tiered visual management system and support continuous improvement programs.
Complete required training and maintain training requirements.
Perform scheduled equipment cleaning and support changeover activities.
Develop equipment and process qualifications and validations.
Maintain a personal development plan and provide an annual performance self-assessment on it.
Initiate work orders.
Operate production equipment according to SOPs to produce clinical and commercial products.