Aseptic Operations Supervisor – Lead with Quality

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with 2%

Paid Holidays

Paid Time Off

Education Assistance Program

Employee Ownership Plan

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana seeks a Supervisor of Aseptic Operations to lead manufacturing of sterile injectables. You will report to the Manager of Aseptic Operations and guide a team to meet cGMP standards, quality, and safety objectives across production, scheduling, and documentation.

You will coach staff, conduct performance reviews, and drive continuous improvement through audits and process optimization, ensuring on-time product release and adherence to regulatory

Qualifications

• Bachelor's Degree in science, engineering, or business preferred
• High School diploma or GED required
• Minimum 2 years manufacturing or operations support experience
• Minimum 1 year leadership experience
• Proficiency with Microsoft Word, Excel, Outlook and enterprise software (e.g., Dynamics, Veeva, PowerBI, TrackWise)

Responsibilities

• Understand, follow, coach, and lead teams to execute production activities per cGMP
• Provide guidance, support, and leadership during daily operations
• Interview, hire, mentor, and develop staff; conduct annual reviews
• Supervise day-to-day production, scheduling, staffing, material management, and audits
• Review and manage batch and system documentation; assist in product release
• Implement training programs to ensure cGMP and EHS compliance
• Develop performance metrics and internal auditing programs
• Lead technical reviews, investigations and process improvement projects
• Resolve technical, material and cGMP problems impacting deadlines
• Provide RCA-based troubleshooting during deviations; gain qualifications for critical operations
• Represent the company during audits and inspections

Skills

Leadership

Manufacturing operations

cGMP compliance

Quality assurance

Team coaching

Education

Bachelor's degree in science/engineering/business

High School diploma or GED

Tools

Microsoft Word

Excel

Outlook

Microsoft Dynamics

Veeva

PowerBI

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, Indiana seeks a Supervisor of Aseptic Operations to lead manufacturing of sterile injectables. You will report to the Manager of Aseptic Operations and guide a team to meet cGMP standards, quality, and safety objectives across production, scheduling, and documentation.

You will coach staff, conduct performance reviews, and drive continuous improvement through audits and process optimization, ensuring on-time product release and adherence to regulatory