Aseptic Ops Supervisor - Lead & Ensure Quality

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 5%

Paid Time Off

Job summary

Simtra BioPharma Solutions is seeking a Supervisor, Aseptic Operations to lead a manufacturing team in sterile injectable production at our Bloomington site. This role ensures adherence to cGMP, regulates batch records, and collaborates with Quality, Technical Services, and Engineering to maintain quality and efficiency.

The position requires 1 year of leadership experience, 2 years in manufacturing/operations support, and a strong background in using enterprise software tools such as Microsoft

Qualifications

• Bachelor's degree in a science, engineering, or business discipline preferred.
• High School diploma or GED required.

Responsibilities

• Lead a team of Operations personnel engaged in manufacturing sterile injectable products.
• Ensure compliance with cGMP and batch records; oversee documentation and release activities.
• Provide guidance and leadership; interview, hire, mentor, and conduct annual performance reviews.
• Oversee day-to-day production, scheduling, staffing, material management, and audits to meet deadlines and quality standards.
• Develop and implement training programs for staff to ensure strict cGMP and EHS compliance.
• Lead process improvement projects and technical reviews; support equipment validation and integration.
• Represent the company during audits and inspections.

Skills

Leadership

Team coaching

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 is seeking a Supervisor, Aseptic Operations to lead a manufacturing team in sterile injectable production at our Bloomington site. This role ensures adherence to cGMP, regulates batch records, and collaborates with Quality, Technical Services, and Engineering to maintain quality and efficiency.

The position requires 1 year of leadership experience, 2 years in manufacturing/operations support, and a strong background in using enterprise software tools such as Microsoft