Manufacturing Associate - Nights
Posted on: February 12, 2024
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Job Title: Manufacturing Associate - Nights
Location: Lexington, MA
About the role:
As the 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 standard operating
procedures (SOP's) for producing clinical and/or commercial
products. You will report to the Supervisor, Manufacturing.
How you will contribute:
- Carry out cGMP manufacturing operations using Standard
Operating Procedures (SOP), Batch Records and Form Preps.
- Troubleshoot and resolve basic process related issues including
recognizing and escalating deviations
- Execution of critical and routine activities to support
- Perform Batch Record, Logbook and Form Prep requests.
- Enter data in the Laboratory Information Management System
(LIMS) , or MODA other business systems
- Review GMP documentation.
- Sample preparation and testing.
- Identify changes needed to documentation.
- Participate in tiered visual management system and support CI
- Manage equipment and support facility related projects
including initiating work orders, assembly and disassembly of
process equipment, perform scheduled cleaning and standardization
- Support change over activities and execution of equipment and
process qualifications and validation.
- May perform as a subject matter expert for equipment or
- Identify process deviations, troubleshoots issues and identify
- May require interaction with equipment, technical and supply
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
- Biotech Certificate would be ideal.
- Proficient at following written instruction in the form of
Batch Records, Form Preps, Technical Protocols and
- Prior troubleshooting skills and full awareness of current Good
- Proficient computer skills.
- May require weekend or holiday off shift support and
flexibility to adjust work schedule to meet production
- Proficient in Aseptic Technique.
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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
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
- 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.
- Climb ladders and work platforms
- Lift, pull or push equipment requiring up to 25-50 lbs. of
- Stoop or bend to check or troubleshoot equipment
- Please be aware that this position is considered "Essential
Personnel." This means that in the case of inclement weather (e.g.
snow storm) you will 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 before 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
This posting excludes Colorado applicants.
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.
USA - MA - Lexington - BIO OPS
Keywords: Takeda, Boston , Manufacturing Associate - Nights, Other , Lexington, Massachusetts
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