Senior Manufacturing Associate Night Shift
Posted on: November 20, 2023
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Job Title: Senior Manufacturing Associate
Location: Lexington, MA (USA)
About the role:
As a Senior Manufacturing Associate, you will perform routine and
non routine manufacturing operations, including work functions in
Cell Culture, Purification, Solution & Equipment Prep areas. You
will operate production equipment according to standard operating
procedures for producing clinical and/or commercial products and
support engineering and validation activities. You will report to
the Supervisor, Manufacturing.
The hours for this role are 6:00PM - 6:30AM on a 2-2-3
How you will contribute:
- Manage cGMP manufacturing operations using Standard Operating
Procedures (SOP), Batch Records and Form Preps.
- Troubleshoot and escalate process related issues
- Create work orders, initiate and document minor
- Enter data in the Laboratory Information Management System
(LIMS), and MODA
- Review manufacturing documentation real-time to ensure
compliance and manage events impacting the schedule
- Coordinate sample preparation and testing
- Perform work in a safe manner, notifying management of safety
issues and risks
- Participate in tiered visual management system and support
continuous improvement initiatives
- Manage equipment and support facility related projects and be a
subject matter expert for improvement projects
- Perform standardization, scheduled cleaning, assembly and
disassembly and process qualifications and validation for
- Provide technical training for area personnel and act as a
- Identify deviations in process, controls, and guidelines
- May work with equipment, technical and supply item vendors
What you bring to Takeda:
- High school diploma and 4-6 years related industry experience
or an Associate's Degree in Life Sciences/Engineering field with 3
years of GMP Manufacturing experience.
- 3 years Cell Culture/Fermentation experience
- Proficient in computer systems and troubleshooting
- Proficient at following written instruction in the form of
Batch Records, Form Preps, Technical Protocols and
- Full awareness of current Good Manufacturing Practices
- Proficient in Aseptic Technique
- Experience with business systems such as, LIMs, MODA and other
- Ability to lift, pull or push equipment requiring up to 25-50
lbs. of force.
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
- 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 around chemicals such as alcohol, acids, buffers and
Celite that may require respiratory protection.
- May require weekend or holiday off shift support as
- May adjust work schedule to meet production demands.
- Wear personal protective equipment such as safety
glasses/goggles, gloves and safety shoes.
- Gown and gain entry to biotechnology/pharmaceutical
- Stand for 6 hours in a production suite, climb ladders and work
- Stooping or bending to check or trouble-shoot 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 may 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.
#GMSGQ #ZR1 #LI-MA1
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 , Senior Manufacturing Associate Night Shift, Other , Lexington, Massachusetts
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