Production Operations Group Lead - Day Shift
Takeda Pharmaceuticals, Round Lake, IL, United States
Production Operations Group Lead
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 (A/B
5:00 a.m.5:30 p.m.) on a 2-2-3 rotating schedule.
Responsibilities include:
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.
Qualifications include:
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:
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 812-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
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 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 (A/B
5:00 a.m.5:30 p.m.) on a 2-2-3 rotating schedule.
Responsibilities include:
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.
Qualifications include:
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:
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 812-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
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.