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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 supervise 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. 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.

How you will contribute:

• Complete and manage multiple floor activities being the primary contact for troubleshooting, issue resolutions and escalations.

• In the absence of the supervisor, you will act on behalf of the supervisor while on the floor.

• Coordinate day's scheduling and staffing plan, including reallocating staff during the day for breaks, lunch, and training.

• Oversight and execution of all routine and critical operations and commissioning and 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

• Monitor material consumption and coordinate all materials deliveries

• Recommend and implement process changes, safety/ergonomic improvements, and ensure work is carried out safely while notifying management of safety issues and risks.

• Conduct interviews, address minor personnel issues, escalate major issues to supervisor, ensure compliance with SOPs and safety guidelines, lead by example, and provide training.

• Initiate deviations or investigations of multiple complexities and work with cross-functional departments to identify root cause

• Implement appropriate corrective actions, assist with investigations, complete action items for GMP investigations and CAPA's and revise and author Standard Operating Procedures/Batch Records.

• Communicate any quality issues/concerns to Supervisor and QA

• Make process decisions, with the help of management and support roles, including the trouble shooting of equipment and corrective action to process deviations.

• Understand operations and contact appropriate support to ensure issues are resolved.

• Will work with equipment and supply item vendors.

What you bring to Takeda:

• Normally requires a high school diploma and 6+ years related industry experience or an Associates 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.

• Can perform manufacturing and sampling operations using aseptic technique

• Operational knowledge of Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, water baths, pH/Conductivity meters

• Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.

• Prior experience or exposure in the following activities is required; standardization and measurements using bench top equipment, aseptic processing, cell culture inoculation and scale up processes, use of bioreactors and centrifuges in the growth of cell cultures, process automation and SAP Enterprising Resource Platform.

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.

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

• Can lift, pull or push equipment requiring up to 25-50 lbs of force.

• Can stand for 6 hours in a production suite.

• Can climb ladders and work platforms.

• Can stoop or bend to check or trouble-shoot equipment operations.

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

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:

$26.92 - $42.31

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.

U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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