Aseptic Manufacturing Supervisor – Lead & Quality

Simtra US LLC; Bloomington (IN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Paid Holidays

Paid Time Off

Education Assistance Program

Employee Ownership Plan

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 compliance, oversee batch records, and coordinate with Quality, Engineering, and other support functions on daily operations.

You'll mentor staff, manage production scheduling, and drive continuous improvements while upholding SISPQ standards. This role offers day-one benefits and a comprehensive benefits package.

Qualifications

• Bachelor's Degree in a science, engineering, or business discipline strongly preferred.
• Minimum 2 years of manufacturing or operations support experience.
• Minimum 1 year leadership experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include Microsoft Dynamics, Veeva, PowerBI, TrackWise, etc.)

Responsibilities

• Understand, follow, coach, and lead teams to execute production activities in accordance with current Good Manufacturing Practices (cGMP).
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.
• Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.
• Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
• Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.
• Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operational efficiency and quality. Implement changes as needed based on assessments.
• Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
• Resolve technical, material and cGMP problems that may impact project deadlines.
• Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable.
• Obtain qualification to perform select critical operation processes.
• Represent the company during audits and inspections.

Skills

Leadership

Manufacturing experience

MS Office proficiency

ERP/enterprise software familiarity

Gemba presence

Education

Bachelor's Degree in science/engineering/business

High School diploma or GED

Tools

Microsoft Dynamics

Veeva

PowerBI

TrackWise

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 compliance, oversee batch records, and coordinate with Quality, Engineering, and other support functions on daily operations.

You'll mentor staff, manage production scheduling, and drive continuous improvements while upholding SISPQ standards. This role offers day-one benefits and a comprehensive benefits package.