Aseptic Ops Supervisor: Lead Sterile Manufacturing Teams

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with CP

Time Off Program

Paid Holidays

Paid Time Off

Paid Parental Leave and more

Education Assistance Program

Employee Ownership Plan

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Supervisor, Aseptic Operations to lead a team manufacturing sterile injectable drug products. You will ensure compliance with cGMP and batch records, collaborate with Quality, Tech Services, Engineering, and management, and foster a high-performance environment focused on SISPQ values.

You will guide daily operations, oversee training, and drive process improvements while maintaining product release timelines and regulatory compliance.

Qualifications

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

Responsibilities

• Lead teams to execute production activities per cGMP as part of the ops leadership group.
• Provide guidance and leadership through daily interactions on the shop floor.
• Interview, hire, mentor staff and conduct performance reviews for direct reports.
• Supervise day-to-day production, scheduling, staffing, material mgmt and audits.
• Review and approve batch and system docs; assist in product release timelines.
• Develop training programs to ensure compliant manufacturing processes.
• Implement performance measures and internal audits; drive improvements.
• Lead technical reviews, investigations and process improvements; validate new equipment.
• Resolve technical, material, and cGMP issues affecting deadlines.
• Provide RCA-based troubleshooting during deviations.
• Obtain qualification to perform select critical operation processes.
• Represent the company during audits and inspections.

Skills

Leadership

Manufacturing

Quality systems

Education

Bachelor’s degree in science, engineering, or business

Tools

Microsoft Dynamics

Veeva

PowerBI

TrackWise

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Supervisor, Aseptic Operations to lead a team manufacturing sterile injectable drug products. You will ensure compliance with cGMP and batch records, collaborate with Quality, Tech Services, Engineering, and management, and foster a high-performance environment focused on SISPQ values.

You will guide daily operations, oversee training, and drive process improvements while maintaining product release timelines and regulatory compliance.