Aseptic Operations Supervisor: Lead Sterile Manufacturing

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 2%

Time Off Program

Adoption Reimbursement Program

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions seeks a Supervisor, Aseptic Operations to lead sterile injectable manufacturing teams on our Bloomington, IN site. You will ensure cGMP compliance, mentor staff, and supervise daily production, scheduling, and documentation activities.

You will also drive process improvements, manage audits, and support onboarding and performance reviews to maintain high quality and safety standards.

Qualifications

• Bachelor’s degree in science, engineering, or business (preferred).
• Minimum 1 year of leadership experience.
• Minimum 2 years of manufacturing or operations support experience.
• Proficiency in Word, Excel, Outlook; familiarity with enterprise systems such as Microsoft Dynamics, Veeva, PowerBI, or TrackWise.

Responsibilities

• Lead a team of Operations personnel engaged in sterile injectable manufacturing.
• Ensure compliance with cGMP and batch records; oversee documentation and release processes.
• Provide coaching, performance reviews, objective setting, and staff development.
• Oversee day-to-day production, scheduling, staffing, material management, compliance, training, and audits.
• Lead investigations, process improvements, and technical reviews; support new equipment validation.

Skills

Leadership experience

Team leadership

People management

Communication

Problem solving

Gemba presence

MS Office proficiency

Dynamics/Veeva/PowerBI/TrackWise

Education

Bachelor’s degree in science, engineering, or business

High school diploma or GED

Tools

Microsoft Dynamics

Veeva

PowerBI

TrackWise

Job description

Simtra BioPharma Solutions seeks a Supervisor, Aseptic Operations to lead sterile injectable manufacturing teams on our Bloomington, IN site. You will ensure cGMP compliance, mentor staff, and supervise daily production, scheduling, and documentation activities.

You will also drive process improvements, manage audits, and support onboarding and performance reviews to maintain high quality and safety standards.