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Job Description

Job Title: Lead Manufacturing Associate- Night Shift

Location: Lexington, MA

About the role:

As a Lead Manufacturing Associate, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands. You will oversee floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained. You will ensure efficient use of material and equipment and assigned personnel in the execution of daily operations and provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. You will report to the Supervisor, Manufacturing.

You will work 6:00pm-6:30am on a rotating 12-hour shift.

How you will contribute:

• 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

• Re-allocate staff during the day (breaks, lunch, training)

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

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

• Responsible for floor inventory and communicating schedule changes

• Monitor material usage 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

• Tiered visual management and continuous improvement

• Support tech transfer activities

• Interview candidates

• Provide feedback on staff’s performance

• Address minor personnel issues timely

• Escalate major personnel issue to the supervisor

• Ensure staff compliance with all relevant documentation and safety guidelines

• Be a role model (Lead by Example)

• Act as a resource/SME 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

• Provide training

• Initiate deviations or investigations of multiple complexities and work with departments to identify cause

• Implement appropriate corrective actions

• Complete action items for GMP investigations and CAPA’s

• Assist supervisor/engineer/facilities with investigations

• Revise and author GMP documentation 

• Communicate any quality issues/concerns to Supervisor

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 preferred.

• 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.

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• 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 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).

• Flexibility to work according to the production schedule. This position will require weekend, holiday and overtime work at times.

• 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 maybe 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  #LI-MA1

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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.

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