Aseptic Operations Leader – Sterile Pharma Manufacturing

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 公司

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, seeks a Supervisor, Aseptic Operations to lead a manufacturing team of sterile injectable products. You will ensure cGMP compliance, coach staff, manage scheduling, documentation, and audits, and partner with Quality, Engineering and Technical Services to meet release goals.

The role demands hands-on leadership, strong communication, and deep knowledge of aseptic processing and regulatory requirements. Growth and safety are prioritized.

Qualifications

• Understand, follow, coach, and lead teams to execute production in accordance with cGMP.
• Interview, hire, mentor, and develop staff; conduct annual reviews.
• Supervise day-to-day production, scheduling, staffing, material management, compliance, training and auditing.
• Review, approve, and manage documentation for batch and system records; assist in product release.

Responsibilities

• Lead production activities in line with cGMP and safety standards.
• Provide guidance and leadership through daily interactions.
• Conduct performance reviews and develop objectives with direct reports.
• Oversee documentation, batch release, and meeting deadlines for quality.
• Develop and implement training to ensure compliant manufacturing processes.
• Lead process improvement projects and technical reviews.
• Support audits and inspections and root-cause analyses.

Skills

Leadership

Gemba presence

Communication

Problem solving

Manufacturing operations

Education

Bachelor's degree in science/engineering/business

High School diploma or GED

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Microsoft Dynamics

Veeva

PowerBI

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, Indiana, seeks a Supervisor, Aseptic Operations to lead a manufacturing team of sterile injectable products. You will ensure cGMP compliance, coach staff, manage scheduling, documentation, and audits, and partner with Quality, Engineering and Technical Services to meet release goals.

The role demands hands-on leadership, strong communication, and deep knowledge of aseptic processing and regulatory requirements. Growth and safety are prioritized.