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Job Description

Job Title: Manufacturing Associate

Location: Lexington, MA

About the role:

You will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. You will operate production equipment according to SOPs for the production of clinical and commercial products. This is an on site role that reports to the manufacturing supervisor.

How you will contribute:

• You will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records, log books and Form Preps
• Troubleshoot and resolve basic process related issues, recognize and escalate deviation
• Complete critical and routine activities to support production
• Enter data in the Laboratory Information Management System (LIMS) , MODA and or other business functions
• Review GMP documentation, identify changes needed to documentation
• Sample preparation and testing
• Participate in tiered visual management system and support CI initiatives
• Complete required training on time
• Initiate work orders and support change over activities.
• Perform standardization, assembly, disassembly, and scheduled cleaning of equipment
• Equipment and process qualifications and validation
• Maintain training requirements, Maintain personal development plan, and provide annual performance self-assessment on development plan

What you bring to Takeda:

• Normally requires a high school diploma and 0-4 years related industry experience or an Associate’s Degree in Life Sciences/Engineering field.
• Biotech Certificate would be ideal.

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 and development opportunities
• Tuition reimbursement

Important Considerations

Please be aware that this position is considered “Essential Personnel.” This means that in the case of inclement weather (e.g. snow storm) you may be expected to 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 prior to any potential inclement weather situation.

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. In this role, 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/or 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, as necessary.
• 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.
• 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.
• Stoop or bend to check or trouble-shoot equipment operations.

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 will 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-MA1 #LI-Onsite

Takeda Compensation and Benefits Summary

For Location:

USA - MA - Lexington - BIO OPS

U.S. Hourly Wage Range:

$18.85 - $29.62

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

Job Exempt

No It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.