Job Description

About the role:

Takeda is seeking a Production Operations Group Lead to supervise activities in the initial inspection, pasteurization, and incubator production areas at our Round Lake, Illinois manufacturing facility. Reporting to the Associate Manager, this role is responsible for ensuring manufacturing goals are achieved while maintaining compliance with cGMP, EHS, and other applicable regulatory requirements. You will drive the efficient use of raw materials, equipment, and workforce resources to deliver high-quality products safely and effectively.

This role is assigned to Night Shift (C/D - 5:00 p.m.-5:30 a.m.) on a 2-2-3 rotating schedule.

How you will contribute:

• Monitor labor and capital spending. Recommend improvements to manufacturing policies, procedures, and programs.
• Provide guidance, support, and leadership through positive daily interactions with employees.
• Supervise daily production, scheduling, staffing, material management, compliance, training, and audits to meet deadlines and quality standards.
• Review and approve batch and system records. Support product release timing goals.
• Ensure staff complete training on time and follow manufacturing processes in compliance with cGMP and EHS requirements.
• Lead simple process improvement projects. Provide manufacturing input for new equipment and process integration and validation.
• Resolve technical, material, and cGMP issues that may affect deadlines. Provide troubleshooting support during process deviations.
• Represent the company during FDA inspections.
• Conduct daily gemba walks to support employee engagement and reinforce safety and GMP practices.
• Apply lean manufacturing principles in simple situations with ongoing coaching.
• Conduct basic auditing tasks under supervision.
• Troubleshoot simple problems with ongoing coaching.

What you bring to Takeda:

• High School Diploma or GED with 5+ years of related experience; or a bachelor's degree in science or engineering, or a related technical field with 2+ years of related experience
• Ability to work effectively across departments and contribute to team leadership in a collaborative environment.
• Strong verbal and written communication, teamwork, and documentation skills, with a focus on customer service and safe performance under pressure.
• Understanding of cGMP and other regulatory requirements relevant to the pharmaceutical or medical industry.
• Understanding and can apply key concepts of Continuous Improvement Process with support.
• Proficient in MS Word, MS Excel.
• Experience working in an FDA regulated environment preferred.

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:

• 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 and holidays, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Must be willing and able to work aligned shift.
• 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 be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions

For Location:
USA - IL - Round Lake - Drug Delivery

U.S. Base Salary Range:
$70,000.00 - $110,000.00

The estimated salary range reflects an anticipated range for this position. The actual base salary 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 base salary 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 and/ or long-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.

Locations
USA - IL - Round Lake - Drug Delivery

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes