Job Information
Takeda Pharmaceuticals Manufacturing Associate in Lexington, Massachusetts
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Job Description
Job Title : Manufacturing Associate
Location : Lexington, MA
About the role:
As a Manufacturing Associate, 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/or commercial products. You will report to the Manufacturing Supervisor.
How you will contribute:
Troubleshoot and resolve basic process related issues.
Accomplish cGMP manufacturing operations using Standard Operating Procedures (SOP), Batch Records and Form Preps.
Recognize and escalate 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 or other departments.
Review GMP documentation.
Sample preparation and testing.
Identify changes needed to documentation.
Participate in tiered visual management system and support CI programs.
Initiate work orders.
Assembly and disassembly of process equipment.
Perform scheduled cleaning of equipment.
Perform standardization of equipment.
Support change over activities.
Implement equipment and process qualifications and validation.
Maintain training requirements.
Develop and maintain personal development plan
Provide annual performance self-assessment on development plan.
Work on assignments that are moderately complex where judgment is required in resolving problems and making routine recommendations.
Receive assignments in the form of objectives with goals and process to meet goals outlined. Work is reviewed by supervisor to measure meeting of goals.
Accomplish tasks through direct operation of cGMP activities.
Perform daily operations of the department and assist coworkers in fulfilling department goals elevating issues to senior staff.
Evaluate and elevate issues to senior staff.
Identify process deviations, troubleshoot issues, and identify process improvements.
All Internal Manufacturing, Materials Management. Technical Operations and Facilities Management with limited exposure to support groups (Quality Assurance, Validation, Quality Control, Process Development and Health, Safety & Environment).
May require interaction with equipment, technical and supply item vendors.
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.
Experience with general aspects of the job with a broad understanding of the detailed aspects of the job.
May perform as a subject matter expert for equipment and/or systems.
Follow written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
Full awareness of current Good Manufacturing Practices.
May adjust work schedule to meet production demands.
Proficient in Aseptic Technique.
Work cohesively in a team environment.
Gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
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.
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.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Ability to 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.
Work around chemicals (alcohols, acids and bases).
Work in a cold, wet environment.
Will work holidays and overtime as required.
May require weekend or holiday off shift support as needed.
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.
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:
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
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
Takeda Pharmaceuticals
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