MANUFACTURING ASSOCIATE

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Job Description Job Title.
Manufacturing Associate Location.
Lexington, MA About the role.
With general supervision you 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.
How you will contribute.
Troubleshoot and resolve process related issues.
Carry out work in a safe manner, notifying management of safety issues and risks.
Identify process deviations, troubleshoots issues and identifies process improvements.
Initiate and document minor deviations and work orders.
Execution of critical and routine production operations.
Perform Batch Record, Log Book and Form Prep requests.
Enter data in the Laboratory Information Management System (LIMS).
Record data into log books, review log book data, and propose document revisions.
Sample preparation and testing.
Assembly and disassembly of process equipment, and perform scheduled cleaning and standardization of equipment Support change over activities Execution of equipment and process qualifications as well as Validation Meet and maintain training requirements, complete required training on time.
Develop and maintain personal development plan.
Provide annual performance self assessment on development plan.
May require interaction with equipment, technical and supply item vendors.
What you bring to Takeda.
High school diploma and 2-4 years related industry experience or an Associates Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience.
Biotech Certificate desirable 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.
May be required to wear personal protective equipment (PPE) and other clean room garments daily.
This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
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.
May be required to perform as a subject matter expert for equipment and/or systems The individual is proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
Possess excellent communication and troubleshooting skills.
Full awareness of current Good Manufacturing Practices.
Proficient computer skills.
Will work holidays and overtime as required.
May be required to adjust work schedule to meet production demands.
Proficient in Aseptic Technique Ability to work cohesively in a team environment Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
Ability to lift, pull or push equipment requiring up to lbs of force.
Ability to stand for 6 hours in a production suite.
Ability to climb ladders and work platforms.
Stooping or bending to check or trouble-shoot equipment operations.
Ability to work around chemicals (alcohols, acids & bases).
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 #LI-Onsite 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.
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Hourly Wage Range.
$ 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.
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based e mployee s may be eligible for s hort - t erm incentives.
U.
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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.
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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 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