Aseptic Operations Supervisor: Sterile Manufacturing

Simtra US LLC; Bloomington (IN); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with Co

Time Off Program

Paid Holidays

Paid Time Off

Paid Parental Leave

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Supervisor, Aseptic Operations to lead a manufacturing team in sterile injectable production. You will ensure cGMP compliance, safety and quality on the shop floor and collaborate across Quality, Technical Services and Engineering.

You will hire, coach and develop staff, manage daily production scheduling, review batch records and support product releases. This role offers Day One benefits and a comprehensive benefits package.

Qualifications

• Minimum 2 years of manufacturing or operations support experience.
• Minimum 1 year of leadership experience.
• Proficiency with MS Word, Excel and Outlook; familiarity with enterprise software.

Responsibilities

• Lead day-to-day aseptic production activities ensuring cGMP compliance.
• Coach and develop staff; conduct performance reviews and set objectives.
• Oversee hiring, mentoring and staff development.
• Manage production scheduling, staffing and material control to meet deadlines.
• Review batch and system documentation; assist product release goals.
• Implement training programs to ensure compliant manufacturing.
• Develop performance metrics and drive internal audits.
• Lead process improvement projects and equipment validation input.
• Resolve technical and cGMP issues impacting timelines.
• Provide guidance during process deviations using root cause analysis.
• Support audits and inspections as a company representative.

Skills

Manufacturing operations experience

Leadership experience

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, IN is seeking a Supervisor, Aseptic Operations to lead a manufacturing team in sterile injectable production. You will ensure cGMP compliance, safety and quality on the shop floor and collaborate across Quality, Technical Services and Engineering.

You will hire, coach and develop staff, manage daily production scheduling, review batch records and support product releases. This role offers Day One benefits and a comprehensive benefits package.