Aseptic Manufacturing Supervisor: Lead Ops & Quality

Simtrabps; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan

Paid Holidays

Job summary

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Supervisor, Aseptic Operations to lead a manufacturing team responsible for sterile injectable products. You will ensure adherence to cGMP, batch records, and quality standards while coordinating with Quality, Engineering, and Technical Services to meet production goals.

You will guide staff performance, conduct reviews, and drive continuous improvement projects, maintaining a strong safety and compliance culture on the shop floor.

Qualifications

• Bachelor's Degree in science, engineering, or business preferred.
• Minimum 2 years of manufacturing or operations support experience.
• Minimum 1 year of leadership experience.
• Proficiency in Microsoft Word, Excel, Outlook; ability to use enterprise software.

Responsibilities

• Lead a team of Operations personnel engaged in sterile injectable drug production.
• Ensure compliance with cGMP and batch records; communicate with Quality, Technical Services, Engineering & Maintenance.
• Oversee staffing, scheduling, documentation review/approval, and release support to meet deadlines and quality standards.
• Drive continuous improvement, investigations, and process changes with RCA tooling where applicable.
• Represent the company during audits and inspections.

Skills

Leadership

Communication

Gemba presence

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, IN, is seeking a Supervisor, Aseptic Operations to lead a manufacturing team responsible for sterile injectable products. You will ensure adherence to cGMP, batch records, and quality standards while coordinating with Quality, Engineering, and Technical Services to meet production goals.

You will guide staff performance, conduct reviews, and drive continuous improvement projects, maintaining a strong safety and compliance culture on the shop floor.