Manufacturing Associate

BioSpace; Lexington (MA); Vor Ort; USD 25.967 - 40.804; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) plan with company match

Paid vacation

Sick time

Zusammenfassung

A leading biopharmaceutical company in Lexington seeks a Manufacturing Associate to perform critical manufacturing operations. You will operate production equipment, troubleshoot issues, and maintain compliance with Good Manufacturing Practices in a controlled environment. The position requires a high school diploma or an Associate's Degree and offers a competitive salary of $18.85 - $29.62 per hour, with opportunities for career growth and benefits.

Qualifikationen

• Requires a high school diploma and 0+ years of experience or an Associate's Degree.
• Biotech Certificate preferred.
• Proficient in following Batch Records, Form Preps, Technical Protocols.

Aufgaben

• Troubleshoot and resolve basic process related issues.
• Complete required training and maintain training requirements.
• Perform scheduled cleaning and standardization of equipment.

Kenntnisse

Proficient at following written instructions

Proficient computer skills

Basic troubleshooting skills

Full awareness of current Good Manufacturing Practices

Ausbildung

High school diploma

Associate's Degree in Life Sciences/Engineering

Biotech Certificate

Jobbeschreibung

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Job Description

With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. You will report to Manufacturing Supervisor.

This is a day shift role, with working hours from 6:00 a.m. to 6:30 p.m. on a rotating 2-2-3京赛车 schedule cale which includes working every other weekend.

How You Will Contribute

• Troubleshoot and resolve basic process related issues
• Recognise and elevate deviation
• Execution of critical and routine activities in support of productions
• Perform batch record, log book and form prep requests
＠お腹いっぱい>Enter data in the Laboratory Information Management System (LIMS), MODA and other business functions
• Review GMP documentation
• Sample preparation and testing
• Identify changes needed for documentation
• Participate in tiered visual management system and support CI initiatives
• Complete required training.
• Initiate work orders
• Assemble and disassemble process equipment
• Perform scheduled cleaning and standardization of equipment
• Support change over activities
• Execution of equipment and process qualifications as well as validation
• Maintain training requirements
• Develop and maintain personal development plan
• Provide annual performance self - assessment on development plan

What You Bring To Takeda

• Normally requires a high school diploma and 0 or more years of experience or an Associate's Degree in Life Sciences/Engineering field.
• Biotech Certificate would be ideal.
• Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
• Proficient computer skills.
• Full awareness of current Good Manufacturing Practices.
• May be required to perform as a subject matter expert for equipment and/or systems.
• Basic trouble shooting skills.
• Proficient in A droitic Technique.

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. 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 Cis or artificial fingernails while in the manufacturing environment.
• Work in a cold Fully 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.
• May be required to adjust work schedule to meet production demands.
• 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 platform.
• Stooping or bending to check or trouble-shoot equipment operations.
• Ability to 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. 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 ournick teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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

$18.85 - $29.62

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.

U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement Wrap

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.