
Senior Manufacturing Associate
Lexington, MassachusettsOn the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Biologics
- Plasma
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
As a Senior Manufacturing Associate, you will perform 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. Will support engineering and validation activities.
How you will contribute:
You will perform cGMP manufacturing operations.
Standard Operating Procedures (SOP), Batch Records and Form
Troubleshoot and escalate process related issues Create work orders
Initiate and document minor deviations
Execute critical, routine and non-routine production operations
Inform management of events impacting schedule
request and execution of GMP documentation
Enter data in the Laboratory Information Management System (LIMS), MODA and other business system
Review manufacturing documentation real time to ensure compliance
Coordinate sample preparation and testing
Propose and review document revisions
Carry out work in a safe manner, notifying management of safety issues and risks
Participate in tiered visual management system and support continuous improvement initiatives
Initiating work orders
Act as subject matter expert for improvement projects
Perform scheduled cleaning of equipment
Assembly and disassembly of process equipment
Perform standardization of equipment
Support change over activities
Build equipment and process qualifications and validation
Provide technical training for area personnel
Contribute to training material development
Maintain training requirements and act as a qualified trainer as required
Develop and maintain personal development plan
Provide annual performance self-assessment
What you bring to Takeda:
Normally requires a high school diploma and 4+ years of experience or an associate's degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience.
Biotech certification preferred
Will 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.
Proficient in Aseptic Technique
Work cohesively in a team environment
Experience with business systems such as, LIMs, MODA and other business systems
Clear understanding of manufacturing processes and the ability to readily identify deviations in process, controls, and guidelines required.
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 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 adjust work schedule to meet production demands.
Proficient in Aseptic Technique
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 platforms.
Stooping or bending to check or trouble-shoot equipment operations.
Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
May require weekend or holiday off shift support as needed
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 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 OPSU.S. Hourly Wage Range:
$18.85 - $29.62The 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 OPSWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Working at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2025. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
Jobs for you
- Specialist Quality (w/m/d) Linz, Austria Category: Quality
- Senior Manufacturing Associate Lexington, Massachusetts Category: Manufacturing/Production
- Senior Data Modeler Bratislava, Slovakia Category: Insights & Analytics
- Director, Strategic Account Management - Southeast Region Florida, Georgia, North Carolina, South Carolina, Remote Category: Market Access
