Aseptic Ops Supervisor: Lead Sterile Manufacturing

Simtra US LLC; Bloomington (IN); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 公司

Time Off Program (Paid Holidays, PTO)

Adoption Reimbursement Program

Education Assistance Program

Job summary

Simtra BioPharma Solutions is seeking a Supervisor, Aseptic Operations in Bloomington, IN. You will lead a team on the manufacturing of sterile injectables, ensuring strict adherence to cGMP, batch records, and quality standards with strong collaboration across Quality, Technical Services, Engineering and Maintenance.

The role emphasizes staff development, performing annual reviews, and driving continuous improvement through audits and process optimization.

Qualifications

• Bachelor's degree in science/engineering or business preferred.
• High School diploma or GED required.
• Minimum 2 years of manufacturing or operations support experience.
• Minimum 1 year of leadership experience.
• Proficiency with Microsoft Word, Excel, Outlook and enterprise software.

Responsibilities

• Lead a team of Operations personnel in manufacturing sterile injectable drug products.
• Ensure compliance to cGMP and batch records; manage documentation for batch and system records.
• Interview, hire, mentor, and conduct performance reviews for direct reports.
• Oversee scheduling, staffing, material management, and training to meet deadlines and quality standards.
• Represent the company during audits and inspections; provide root cause analysis for deviations.

Skills

Leadership

Gemba presence

cGMP knowledge

Team coaching

Documentation

Problem solving

Communication

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 is seeking a Supervisor, Aseptic Operations in Bloomington, IN. You will lead a team on the manufacturing of sterile injectables, ensuring strict adherence to cGMP, batch records, and quality standards with strong collaboration across Quality, Technical Services, Engineering and Maintenance.

The role emphasizes staff development, performing annual reviews, and driving continuous improvement through audits and process optimization.