Aseptic Manufacturing Lead

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 
m

Education Assistance

Employee Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, seeks a Supervisor, Aseptic Operations to lead a manufacturing team for sterile injectable products. You will ensure cGMP compliance, manage batch records, and collaborate with Quality, Technical Services, Engineering, and other support departments.

The role emphasizes safety, quality, and timely product releases on a fast-paced production floor. You will develop staff, conduct performance reviews, and drive process improvements while

Qualifications

• Bachelor's degree in science, engineering, or business preferred; strong candidates welcome.
• High School diploma or GED required.
• Minimum 2 years of manufacturing or operations support experience.
• Minimum 1 year of leadership experience.
• Computer proficiency in Word, Excel, Outlook and enterprise software (e.g., Dynamics, Veeva, PowerBI, TrackWise).

Responsibilities

• Lead a team of Operations personnel engaged in manufacturing sterile injectable products.
• Ensure compliance with cGMP and batch records; interact with Quality, Technical Services, Engineering & Maintenance.
• Interview, hire, mentor, and develop staff; conduct annual performance reviews.
• Oversee production, scheduling, staffing, materials management, compliance, training and auditing to meet deadlines and quality.
• Review and approve batch and system documentation; support product release.
• Lead training programs for cGMP and EHS compliance.
• Drive performance measurement and internal audits; implement improvements.
• Lead technical reviews and process improvements; support equipment validation.
• Resolve technical and cGMP issues impacting deadlines.

Skills

Leadership

Communication

Problem solving

Gemba presence

Microsoft Office

Education

Bachelor's Degree in Science/Engineering/Business

High School Diploma or GED

Tools

Microsoft Dynamics

Veeva

PowerBI

TrackWise

Excel

Job description

Simtra BioPharma Solutions in Bloomington, Indiana, seeks a Supervisor, Aseptic Operations to lead a manufacturing team for sterile injectable products. You will ensure cGMP compliance, manage batch records, and collaborate with Quality, Technical Services, Engineering, and other support departments.

The role emphasizes safety, quality, and timely product releases on a fast-paced production floor. You will develop staff, conduct performance reviews, and drive process improvements while