Lead Manufacturing Technician

How you will contribute:

• Serve as the primary point of contact for troubleshooting, issue resolution, and escalation as needed.
• Coordinate daily scheduling, staffing, and real-time staff assignments to support operational needs.
• Oversee and execute routine and critical manufacturing operations, including commissioning and changeover/validation activities.
• Ensure documentation is completed, reviewed, and maintained in accordance with good documentation practices and cGMP requirements.
• Manage floor inventory, monitor material usage, and coordinate material deliveries and schedule changes.
• Promote safe, compliant operations by reinforcing safety practices, identifying risks, and escalating concerns appropriately.
• Support continuous improvement by applying visual management practices and recommending process, safety, and ergonomic enhancements.
• Provide team leadership through training, coaching, performance feedback, and assessment of staff skills and development needs.
• Support quality systems by initiating and contributing to deviations, investigations, CAPAs, and related GMP documentation.
• Collaborate with cross-functional teams, including QA, engineering, facilities, and operations, to resolve issues and support tech transfer activities.

What you bring to Takeda:

• High school diploma with 6+ years of related industry experience, or an associate degree in life sciences, engineering, or a related field with 5+ years of GMP manufacturing experience.
• Prior experience in a manufacturing lead, team support, or coordination role preferred.
• Biotech certificate or other relevant technical certification preferred.
• Experience working with systems such as SAP, LIMS, and TrackWise preferred.
• Demonstrated proficiency in aseptic technique and cleanroom manufacturing practices.
• Working knowledge of manufacturing systems, production equipment, and routine operational processes.
• Strong understanding of cGMP requirements and applicable regulatory expectations, including agencies such as FDA and EMA.

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. Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas. Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force. Ability to stand for up to 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 work around chemicals (alcohols, acids & bases). 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.