Senior Manufacturing Associate

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Job Description

You will report to Days, 6:00 am – 6:30 pm, 2-2-3, 12.5 hours shift, off every alternate weekend. Due to business need, on select occasions, employees may work overtime.

The Senior Manufacturing Associate will implement important, routine, and non-routine manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operate production equipment according to SOPs to produce clinical and commercial products. Will support engineering and validation activities.

How you will contribute:

You will accomplish cGMP manufacturing operations using Standard Operating Procedures (SOP), Batch Records and Form Preps. Responsibilities include

• Troubleshoot and escalate process related issues
• Create work orders
• Initiate and document minor deviations
• Build important, routine, and non-routine production operations
• Manage events affecting schedule request
• Perform Batch Record, Logbook, and Form Prep request
• Enter data in the Laboratory Information Management System (LIMS)
• Record data into logbooks
• Review manufacturing documentation real-time to ensure compliance
• Coordinate sample preparation and testing
• Propose and review document revisions
• Accomplish work in a safe manner, notifying management of safety issues

You will manage equipment and support facility related projects by

• Participate in tiered visual management system and support continuous improvement programs
• Initiate work orders
• Be a subject matter expert for improvement projects
• Perform scheduled cleaning of equipment, assembly and disassembly of process equipment and perform standardization of equipment
• Support change over activities
• Build equipment and process qualifications and validation

Work with management you will

• Provide technical training for area personnel
• Contribute to training material development
• Meet and maintain training requirements
• Maintain personal development plan
• Provide annual performance self-assessment

What you bring to Takeda

• High School diploma or associate degree in Life Sciences/Engineering field
• 1+ years of GMP Manufacturing experience
• Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures
• Full awareness of current Good Manufacturing Practices
• Proficient in Aseptic Technique
• Work cohesively in a team environment
• Experience with business systems such as, LIMs, MODA and other business systems

Important Considerations

• Will work holidays and overtime
• May adjust work schedule to meet production demands
• Wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
• Gown and gain entry to biotechnology/pharmaceutical manufacturing areas
• Lift and push equipment requiring up to 25-50 lbs. of force.
• Stand for 6 hours in a production suite
• Climb ladders and work platforms
• Stoop or bend to check or trouble-shoot equipment operations
• Work around chemicals (alcohols, acids & bases)
• Please be aware that this position is considered "Essential Personnel." This means that in the case of inclement weather (e.g., snowstorm) you who occupies you may report to work for their normal shift if management deems necessary. To ensure "Essential Personnel" are safe during inclement weather situations Shire may provide lodging, shuttle service, and food (depending on the severity and duration of the inclement weather event). These details will be provided by management before any potential inclement weather situation.
• All Internal Manufacturing, Materials Management, Technical Operations and Facilities Management with limited exposure to support groups (Validation, Quality Control, Process Development and Health, Safety & Environment. Vendor
• May require interaction with equipment, technical and supply item vendors

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

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.

The final salary offered for this position may take into account many factors including location, skills, education, and experience

This posting excludes Colorado applicants.

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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