Overview
Join to apply for the Senior Manufacturing Associate role at TAKEDA PHARMACEUTICALS AMERICA, INC.
On the Global Manufacturing and Supply (GMS) team at Takeda, you'll be part of a rapidly transforming industry that's applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms : Small Molecules, Biologics, Plasma, Cell and Gene.
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
Job Details — Location : Lexington, Massachusetts. Job ID : R0162455. Date posted : 09 / 10 / 2025.
Responsibilities
- Perform manufacturing operations in accordance with cGMP requirements.
- Follow Standard Operating Procedures (SOPs), Batch Records, and Form Preps; troubleshoot and escalate process-related issues; create work orders.
- Initiate and document minor deviations; execute critical, routine, and non-routine production operations.
- Inform management of events impacting schedule; request and execution of GMP documentation.
- Enter data in Laboratory Information Management System (LIMS), MODA, and other business systems; review manufacturing documentation in real time for compliance.
- Coordinate sample preparation and testing; propose and review document revisions.
- Perform work safely and notify management of safety issues and risks.
- Participate in tiered visual management systems and support continuous improvement initiatives.
- Initiate work orders; act as subject matter expert for improvement projects.
- Perform scheduled cleaning of equipment; assemble / disassemble process equipment; standardize equipment.
- Support changeover activities; build equipment and process qualifications and validation; provide technical training for area personnel.
- Contribute to training material development; maintain training requirements and act as a qualified trainer as required.
- Develop and maintain personal development plans; provide annual performance self-assessment.
What You Bring To Takeda
Normally requires a high school diploma and 4+ years of experience or an associate's degree in Life Sciences / Engineering with 3 years of GMP Manufacturing experience.Biotech certification preferred.Subject matter expert for equipment and / or systems; proficient at following written instructions (Batch Records, Form Preps, Technical Protocols, Procedures).Excellent communication and troubleshooting skills; full awareness of current Good Manufacturing Practices.Proficient computer skills; proficiency in Aseptic Technique.Ability to work cohesively in a team; experience with business systems such as LIMS, MODA, and other systems.Clear understanding of manufacturing processes and ability to identify deviations in processes, controls, and guidelines.Important Considerations
Work in a controlled environment requiring gowning and protective clothing; may require hearing protection in loud areas.Remove makeup, jewelry, contact lenses, nail polish, and artificial nails in manufacturing areas.Work in cold, wet environments; may require weekend or shift work to meet production demands.Work around chemicals that may require respiratory protection; may require weekend or holiday off- shift support as needed.Ability to lift / pull / push 25-50 lbs; stand for up to 6 hours; climb ladders and work on platforms; stoop or bend to troubleshoot equipment.Must be able to gown and enter biotechnology / pharmaceutical manufacturing areas.Essential Personnel : in inclement weather, may be required to report to work; lodging / shuttle / food may be provided as determined by management.More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that strives for excellence in a diverse and inclusive workplace, committed to delivering Better Health and a Brighter Future worldwide.
EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, veteran status, or other protected status in accordance with applicable laws.
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