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Job Description

About the role:

The Manufacturing Supervisor reports to the Associate Director of Inspection. You are responsible for implementing and supervising all activities in the filling area at Takeda’s Round Lake, Illinois manufacturing facility, to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply; focus is on optimization in the use of raw materials, equipment and employees in producing quality products; may monitor and oversees labor and capital expenditures; may assist in developing budgets; recommends manufacturing policies, procedures and programs.

How you will contribute:

• Provides guidance, support, direction, and leadership through positive interactions with all employees during daily operations.

• Supervises the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities – to meet customer requirements including deadlines and quality standards.

• Interviews, hires, coaches, motivates, develops and disciplines staff; conducts annual performance reviews for all team members; assists in setting performance objectives and development plans; monitors progress.

• Reviews, approves, and manages documentation for batch and system records; assists in release of product for distribution; assists in meeting product release time goals.

• Supports training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.

• Develops and implements performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality; implements changes as needed based on assessments.

• Performs/leads technical reviews, investigations, and process improvement projects; provides manufacturing input into integration and validation of new equipment and processes.

• Resolves technical, material and cGMP problems that may impact project deadlines; provides guidance and troubleshooting assistance as needed during a deviation in the process.

• Represents the company during FDA inspections; provides information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.

• Performs daily Gemba walks to engage with employees and ensure their following proper safety practices.

• Demonstrated interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment.

• Experience working in an FDA regulated environment preferred.

• In-depth process knowledge of related manufacturing equipment and processes.

• Ability to manage multiple priorities in a manufacturing plant setting.

• Ability to analyze and interpret scientific and statistical data.

• Have strong teamwork and communication skills, both verbally and written, good documentation skills, customer oriented.

What you bring to Takeda:

• High School Diploma or GED plus 4+ years of related work experience OR Bachelors' degree in science, engineering or other related technical field and 2+ years of related work experience.

• Some leadership experience preferred.

• Ability to work safely and effectively under stressful conditions.

• Strong professional writing skills and ability to prepare technical reports.

• Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.

• Strong assessment and troubleshooting skills.

• Ability to respond to detailed inquiries, and present information to groups and senior management.

• May be required to supervise multiple groups/shifts.

• Good computer skills. Proficient in MS Word, MS Excel.

• Must be willing to work night shift.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

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:

• Must be willing and able to work aligned shift.

• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

• Must be able to carry up to 30 lbs., lift up to 30lbs, push/pull up to 30lbs (with assistance of material handling equipment).

• Must be able to stand and/or walk for an extended period over an 8–12-hour shift between rooms and across the site.

• Indoor working conditions.

• Will work around moving equipment and machinery.

• 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.

• Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• May work in a cold, hot or wet environment.

• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• May be required to work in a confined area.

• Some Clean Room and cool/hot storage conditions

• Must be able to work on multiple shifts, including weekends, to support a 24/7 manufacturing operation as needed.

• Must be able to work non-traditional work hours or work extended hours, including weekends and holidays, as needed.

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.

This posting excludes Colorado applicants.

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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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