Lead Manufacturing Associate

Takeda Pharmaceutical Company Limited; Lexington (MA); On-site; USD 45,000 - 70,000; Full time

Job summary

Takeda Pharmaceutical Company Limited in Lexington, MA is seeking a Lead Manufacturing Associate to drive operational excellence on the 2-2-3 rotating shift from 6:00 PM to 6:30 AM. You will lead floor operations, ensure aseptic, cGMP compliance, manage materials and schedule changes, and coach staff on safety and continuous improvement.

You will collaborate with QA, engineering, facilities, and operations to support tech transfer, deviations, CAPAs, and documentation, while striving for

Qualifications

• High school diploma with 6+ years of related industry experience or associate degree with 5+ years GMP experience.
• Experience in a manufacturing lead, team support, or coordination role preferred.
• Biotech certificate or other relevant technical certification preferred.
• Experience working with SAP, LIMS, and TrackWise preferred.
• Demonstrated proficiency in aseptic technique and cleanroom manufacturing practices.

Responsibilities

• 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.

Skills

Troubleshooting

Scheduling

Team leadership

cGMP knowledge

Education

High school diploma with 6+ years GMP experience

Associate degree in life sciences/engineering

Tools

SAP

LIMS

TrackWise

Job description

Job Description

About the role

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.

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

The 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.

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.