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Manufacturing Lead - Days

Cambridge, Massachusetts
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On 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.

Job ID R0113931 Date posted 02/07/2024 Location Cambridge, Massachusetts

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’sPrivacy 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

Job Title: Manufacturing Lead

Location: Cambridge, MA

About the role:

As the Manufacturing Lead, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands. You will oversee and execute floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained. You will ensure efficient use of material and equipment and assign personnel in the execution of daily operations. You will report to the Supervisor, Manufacturing.

How you will contribute:

  • Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations.

  • Provide support to integrate best practices into manufacturing.

  • Primary contact for troubleshooting and issue resolution or escalation

  • Create and follow-up on work orders

  • Communicate/ coordinate days scheduling and staffing plan

  • Oversight and execution of all routine and critical operations and commissioning and changeover validation activities

  • Ensure documentation is complete, reviewed and meet good documentation practices (forms, logbooks, form preps, batch records)

  • Responsible for floor inventory and communicating schedule changes and monitor material consumption and coordinate all materials deliveries

  • Recommend/Implement process changes/improvements or safety/ergonomic improvements.

  • Ensure work is carried out in a safe manner, notifying management of safety issues and risks

  • Tiered visual management and continuous improvement

  • Support tech transfer activities

  • Provide feedback and address minor personnel issues on staff's performance and escalate major personnel issue to the supervisor

  • Ensure staff compliance with all relevant documentation and safety guidelines

  • Be a role model and act as a resource and subject matter expert for staff

  • Use safe work practices and behaviors

  • Conduct training and assess effectiveness, help identify training needs, assess staff skills and provide feedback to Supervisor, develop training material and provide training.

  • Initiate deviations or investigations of several complexities and work with cross-functional departments to identify root cause and communicate quality concerns to Supervisor and Quality Assurance

  • Implement appropriate corrective actions and complete action items for GMP investigations and CAPA's

  • Assist supervisor/engineer/facilities with investigations

  • Revise and author GMP documentation

  • Expected to act on behalf of the supervisor while on the floor

  • Flexibility to work according to the production schedule

What you bring to Takeda:

  • Normally requires a high school diploma and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience.

  • Biotech Certificate and prior leadership experience would be ideal.

  • Experience with systems such as SAP, LIMS and TrackWise is a plus

  • Proficient in aseptic technique

  • Operational knowledge of Systems and general equipment

  • Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMA) to ensure inspection readiness of department.

  • May require weekend or holiday off shift support and flexibility to adjust work schedule to meet production demands.

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 health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs and company match of charitable contributions

  • Family Planning Support

  • Professional training and development opportunities

  • Tuition reimbursement

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.
  • Climb ladders and work platforms
  • Stoop or bend to check or trouble-shoot equipment operations.
  • Lift, pull or push equipment requiring up to 25-50 lbs. of force.
  • Stoop or bend to check or trouble-shoot equipment operations.
  • 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 world.

This posting excludes Colorado applicants.

#GMSGQ #ZR1

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 - Alewife - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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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 2024.
  • 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.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

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.

Exterior of Takeda Building

About our location

Cambridge, Massachusetts


View Map of Cambridge, Massachusetts

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