Manufacturing Associate II
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 areas. 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 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. Takeda may provide lodging, shuttle service, and food depending on the severity and duration of the weather event. The role is based at Takeda’s BIO OPS location in Lexington, Massachusetts. The position is full-time and hourly, with an estimated wage range of $18.70 to $29.35 per hour. Actual pay may depend on qualifications, relevant experience, skills, education, certifications or licenses, and location.
Requirements
- High school diploma and 2–4 years of related industry experience, or an associate 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 serve as a subject matter expert for equipment and/or systems.
- Ability to work in a controlled environment requiring special gowning and protective clothing, potentially including hearing protection.
- Must remove makeup, jewelry, contact lenses, nail polish, and artificial fingernails while in the manufacturing environment.
- Ability to work in cold, wet environments and around chemicals such as alcohol, acids, buffers, and Celite, which may require respiratory protection.
- Ability to stoop or bend to check or troubleshoot equipment operations.
- Ability to lift, pull, or push equipment requiring up to 25–50 pounds of force.
- Ability to stand for six hours in a production suite.
- Ability to climb ladders and work platforms.
- Availability for multiple shifts, weekends, and supplemental hours as necessary.
Nice To Haves
- Biotech Certificate desired.
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 departmental 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.
- Support changeover activities.
- Develop equipment and process qualifications and validation.
- Maintain a personal development plan and provide an annual performance self-assessment on that plan.
- Initiate work orders.
- Work multiple shifts, including weekends, or supplemental hours as necessary.
- Report to work for the normal shift during inclement weather when management deems it necessary.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
