Aseptic Operations Supervisor – Sterile Biopharma

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 회사

Paid Holidays

Paid Time Off

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Supervisor, Aseptic Operations to lead a manufacturing team for sterile injectable products. You will ensure cGMP adherence, batch record integrity, and collaboration with Quality, Technical Services, and Engineering to support production goals.

The role requires 2+ years in manufacturing or operations support, 1+ year leadership, and strong skills with GMP systems and enterprise software. Eligible benefits and a growth-focused team await.

Qualifications

• Bachelor's degree in a science, engineering or business discipline strongly preferred.
• High School diploma or GED required.
• Minimum 2 years of manufacturing or operations support experience required.
• Minimum 1 year leadership experience required.
• Computer proficiency in Microsoft Word, Excel, and Outlook and ability to use enterprise software (e.g., Dynamics, Veeva, PowerBI, Trackwise).

Responsibilities

• Understand, follow, coach, and lead teams to execute production activities per cGMP.
• Provide guidance, support, direction and leadership during daily operations.
• Interview, hire, mentor, and develop staff; conduct annual performance reviews.
• Supervise day-to-day production, scheduling, staffing, material management, compliance and training.
• Review, approve, and manage batch documentation; assist product release and meeting deadlines.
• Implement and support training programs to ensure GMP and EHS compliance.
• Develop performance metrics and internal audits; implement changes as needed.
• Lead technical reviews, investigations and process improvement projects.
• Resolve technical, material and cGMP problems impacting deadlines.
• Provide guidance during process deviations using RCA tools when applicable.
• Obtain qualification to perform select critical operation processes.
• Represent the company during audits and inspections.

Skills

Leadership

People development

Problem solving

Quality compliance

Education

Bachelor's Degree in a science, engineering, or business discipline

High School diploma or GED

Tools

Microsoft Dynamics

Veeva

PowerBI

Trackwise

Microsoft Word

Microsoft Excel

Outlook

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Supervisor, Aseptic Operations to lead a manufacturing team for sterile injectable products. You will ensure cGMP adherence, batch record integrity, and collaboration with Quality, Technical Services, and Engineering to support production goals.

The role requires 2+ years in manufacturing or operations support, 1+ year leadership, and strong skills with GMP systems and enterprise software. Eligible benefits and a growth-focused team await.