Senior Manager – Aseptic Operations
| Company | Simtra BioPharma Solutions |
|---|---|
| Location | Bloomington, IN, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Bachelor’s degree in a scientific or engineering discipline required.
- Minimum 8 years of experience in aseptic manufacturing within a regulated pharmaceutical environment.
- At least 5 years in a leadership role, with demonstrated experience managing teams in a cGMP setting.
- Strong knowledge of GMP regulations and international regulatory agency requirements.
- Proficiency in Microsoft Office and enterprise systems (e.g., JDE, BPLM, Pilgrim, Trackwise).
Responsibilities
- Lead the execution of manufacturing plans to ensure Right First Time and On Time Delivery KPIs are met.
- Champion a culture of safety, continuous improvement, and lean manufacturing principles (6S).
- Develop and lead a high-performing operations team by hiring, coaching, and setting clear performance expectations.
- Foster strong cross-functional relationships with Quality, Engineering, Technical Services, and Program Management teams.
- Review, approve, and drive timely closure of deviations, SOPs, protocols, and validations.
- Represent the Aseptic Operations Cell during client engagements and audits.
- Manage department budgets and ensure performance meets business objectives.
- Drive a customer-focused mindset, ensuring product value and quality are consistently delivered.
Preferred Qualifications
-
No preferred qualifications provided.