About the role:
- Implement and supervise production area activities at Takedaโs Round Lake, IL manufacturing facility to meet manufacturing goals and project deadlines while complying with cGMP, EHS guidelines, and applicable regulations.
- Optimize use of raw materials, equipment, and employees to produce quality products.
- May oversee labor/capital expenditures, assist with budgets, and recommend manufacturing policies, procedures, and programs.
Work Schedule:
- 6:00amโ6:30pm (2-2-3 rotating schedule)
How you will contribute:
- Provide guidance, support, direction, and leadership during daily operations.
- Supervise day-to-day production, scheduling, staffing, material management, compliance, training, and auditing to meet customer deadlines and quality standards.
- Interview, hire, coach, motivate, develop, and discipline staff; conduct annual performance reviews and monitor progress.
- Review/approve/manage batch and system records; assist with product release and release timing goals.
- Emphasize training to ensure consistent cGMP/EHS-compliant execution.
- Develop/implement performance measurement and internal auditing; drive improvements.
- Lead technical review, investigations, and process improvement; provide input for equipment/process integration and validation.
- Resolve technical/material/cGMP problems impacting deadlines; support troubleshooting during deviations.
- Represent the company during FDA inspections.
- Perform daily gemba walks to ensure proper safety practices.
What you bring:
- High school diploma/GED + 4+ years related experience OR Bachelorโs in science/engineering/technical field + 2+ years (leadership experience preferred).
- Interpersonal/leadership skills; ability to interface cross-functionally and lead in a team environment.
- FDA-regulated environment experience preferred.
- In-depth knowledge of manufacturing equipment/processes.
- Ability to manage multiple priorities; analyze/interpret scientific and statistical data.
- Strong teamwork, communication, documentation, customer focus; work safely under stress.
- Strong technical writing/report preparation.
- Knowledge of cGMPs and applicable regulatory guidelines.
- Strong assessment/troubleshooting; ability to respond to inquiries and present to groups/senior management.
- May supervise multiple groups/shifts.
- Good computer skills (MS Word, MS Excel).
How you will contribute (working conditions):
- Controlled environment gowning/protective clothing; remove makeup/jewelry/contact lenses/nail polish/artificial nails.
- Cold/wet environment; chemicals requiring respiratory protection; multiple shifts/weekends/overtime.
- Ability to stand/walk 8โ12 hours; lift/push/pull up to ~30 lbs (with equipment) and carry up to 30 lbs.
- Work around moving equipment; some clean room and cool/hot storage; confined area possible.