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