Aseptic Operations Supervisor: Lead Sterile Manufacturing

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana seeks a Supervisor, Aseptic Operations to lead manufacturing of sterile injectable products. You will ensure cGMP compliance, guide a team, and collaborate with Quality, Engineering and Maintenance to meet safety, quality and schedule targets.

The role emphasizes shop-floor leadership, training, and participation in audits and continuous improvement initiatives to deliver high-quality medicines.

Qualifications

• Bachelor's degree in a science, engineering or business discipline preferred.
• Minimum 2 years of manufacturing or operations support experience.
• Minimum 1 year leadership experience required.
• Computer proficiency in Microsoft Word, Excel, Outlook and enterprise software.

Responsibilities

• Lead day-to-day production, scheduling, staffing and material management to meet customer requirements.
• Review, approve and manage batch and system documentation; support release of product.
• Implement training programs to sustain cGMP and EHS compliance.
• Drive performance measurement and internal audits to improve efficiency and quality.
• Lead technical reviews, investigations and process improvements; support equipment validation.

Skills

Leadership

Team coordination

Communication

Gemba presence

Education

Bachelor's degree in science/engineering/business

High School diploma or GED

Tools

Microsoft Dynamics

Veeva

PowerBI

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, Indiana seeks a Supervisor, Aseptic Operations to lead manufacturing of sterile injectable products. You will ensure cGMP compliance, guide a team, and collaborate with Quality, Engineering and Maintenance to meet safety, quality and schedule targets.

The role emphasizes shop-floor leadership, training, and participation in audits and continuous improvement initiatives to deliver high-quality medicines.