Manufacturing Associate II

Takeda Pharmaceutical Co.; Lexington (MA); Presencial; USD 26.000 - 40.000; Jornada completa

Descripción de la vacante

Takeda in Lexington, MA is seeking a Manufacturing Associate II to perform routine and critical manufacturing operations across Cell Culture, Purification, and Solution & Equipment Prep areas. You will operate production equipment according to SOPs for clinical and commercial products, on a 2-2-3 rotating shift from 6:00 AM to 6:30 PM.

You will troubleshoot issues, document results, enter data into LIMS/MODA, and support CI programs while maintaining GMP compliance and safety standards.

Formación

• Requires a high school diploma and 2-4 years related industry experience or an Associate's Degree in Life Sciences/Engineering field.
• Biotech Certificate desired.
• Proficient in aseptic technique and following written instructions.
• Familiar with GMP and have proficient computer skills.

Responsabilidades

• Troubleshoot and resolve basic process related issues.
• Recognize and escalated deviation.
• Implement critical and routine activities to support production.
• Perform Batch Record, Log Book and Form Prep requests.
• Enter data in the Laboratory Information Management System (LIMS) and MODA.
• Review GMP documentation.
• Sample preparation and testing.
• Identify changes needed to documentation.
• Participate in tiered visual management system and CI programs.
• Complete required training.
• Initiate work orders.

Conocimientos

Aseptic Technique

Written Instructions

GMP Compliance

Computer Skills

Educación

High school diploma

Associate's degree in Life Sciences/Engineering

Biotech Certificate

Herramientas

LIMS

MODA

Descripción del empleo

Job Description

About the role

As a Manufacturing Associate II, you will perform routine and critical manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas. You will operate production equipment according to SOPs for producing clinical and commercial products.

You will work on a 2-2-3 rotating shift with working hours from 6:00 AM to 6:30 PM.

How you will contribute

• Troubleshoot and resolve basic process related issues
• Recognize and escalated deviation
• Implement critical and routine activities to support production
• Perform Batch Record, Log Book and Form Prep requests
• Enter data in the Laboratory Information Management System (LIMS), MODA and other departments
• Review GMP documentation
• Sample preparation and testing
• Identify changes needed to documentation
• Participate in tiered visual management system and support CI programs
• Complete required training
• Perform scheduled cleaning of equipment
• Support change over activities
• Develop equipment and process qualifications and validation
• Maintain personal development plan
• Provide annual performance self-assessment on development plan
• Maintain training requirements
• Initiate work orders

What you bring to Takeda

• Requires a high school diploma and 2-4 years related industry experience or an Associate's Degree in Life Sciences/Engineering field.
• Biotech Certificate desired
• Proficient in Aseptic Technique
• 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 computer skills.
• May be required to perform as a subject matter expert for equipment and/or systems

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 or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Stoop or bend to check or trouble-shoot equipment operations.
• Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force.
• Ability to stand for 6 hours in a production suite.
• Ability to climb ladders and work platforms.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Please be aware that this position is considered "Essential Personnel." This means that in the case of inclement weather (e.g. snow storm) the employee who occupies this position 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.

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.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location

USA - MA - Lexington - BIO OPS

U.S. Hourly Wage Range

$18.70 - $29.35

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

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

NoIt 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.