Lead Manufacturing Associate

Takeda; Lexington (MA); Presencial; USD 45.000 - 72.000; Jornada completa

Descripción de la vacante

Takeda in Lexington, MA is seeking a Lead Manufacturing Associate to drive operational excellence on the manufacturing floor. You will lead scheduling, staff coordination, and execution of routine and critical operations, ensuring cGMP compliance and strict aseptic practices.

The role emphasizes collaboration with QA, engineering, facilities, and operations to support tech transfer and continuous improvement in a highly regulated biotech environment. Shift coverage includes evenings and nights.

Formación

• Six plus years in related industry with high school diploma or five plus years with an associate degree.
• Experience leading manufacturing floor activities and coordinating scheduling.
• Biotech or GMP manufacturing experience preferred.

Responsabilidades

• Troubleshoot, resolve issues, and escalate as needed on the manufacturing floor.
• Coordinate daily scheduling, staffing, and real-time assignments.
• Oversee routine and critical operations including commissioning and changeover/validation.
• Ensure documentation complies with cGMP and good documentation practices.
• Manage floor inventory and material deliveries, and adjust schedules as needed.
• Promote safe, compliant operations and identify risks for escalation.

Conocimientos

Operational leadership

Safety compliance

Aseptic technique

Documentation practices

Cross-functional collaboration

Educación

High school diploma + 6+ years GMP experience

Associate degree in life sciences/engineering + 5+ years GMP

Biotech certificate preferred

Herramientas

SAP

LIMS

TrackWise

Descripción del empleo

Job Description

As a Lead Manufacturing Associate, you will drive operational excellence in manufacturing and scheduling to meet site demands, leading floor operations with a strong focus on safety, aseptic practices, and full compliance with cGMP standards. You will optimize the use of materials, equipment, and personnel to support efficient day-to-day execution, while also providing technical leadership through close collaboration with cross-functional support teams to ensure process changes and improvements are accurately implemented on the manufacturing floor. You will also help identify and integrate best practices, where appropriate, to enhance manufacturing performance and continuous improvement.

This role works on a 2-2-3 rotating shift with working hours from 6 00PM - 6 30AM.

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

• 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.

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

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 OPS

U.S. Hourly Wage Range

$32.64 - $51.30

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 OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No

It 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.