Sr Manufacturing Associate

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Job Description

Location: Lexington, MA

About the role:

As a Sr. Manufacturing Associate, you will perform manufacturing operations, including work functions in Cell Culture, Purification, Solution and Equipment Prep areas. You will operate production equipment according to SOPs for the production of clinical and commercial product and support engineering and validation activities. You will report to the Supervisor, Manufacturing. This is a 6am-6:30pm 2-2-3 schedule role.

How you will contribute:

• Perform cGMP manufacturing operations using Standard Operating Procedures (SOP), Batch Records and Form Preps.
• Troubleshoot and escalate process related issues
• Create work orders
• Initiate and document minor deviations
• Complete production operations
• Manage events affecting schedule request and execution of GMP documentation
• Enter data in the Laboratory Information Management System (LIMS), MODA and other business systems
• Review manufacturing documentation to ensure compliance
• Coordinate sample preparation and testing
• Propose and review document revisions
• Perform work in a safe manner, notifying management of safety risks
• Participate in tiered visual management system and support continuous improvement projects
• Initiate work orders
• Be subject matter expert for improvement projects
• Perform scheduled cleaning and standardization of equipment and assembly and disassembly of process equipment
• Support change over activities
• Implement equipment, process qualifications and validation
• Provide technical training for area personnel and input on training material development, maintain training requirements and act as a qualified trainer
• May adjust work schedule to meet production demands and may require weekend or holiday off shift support
• Lift, pull or push equipment requiring up to 25-50 lbs. of force.
• Stand for 6 hours in a production suite.
• Climb ladders and work platforms.
• Stooping or bending to check or trouble-shoot equipment operations.

What You Bring to Takeda:

• Typically requires a High School diploma and 4+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience.
• Proficient in Aseptic Technique

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional training opportunities
• Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
• Gown and gain entry to biotechnology/pharmaceutical manufacturing areas.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants

#GMSGQ #ZR1 #LI-Onsite

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment 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, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time