Aseptic Operations Supervisor – Weekend PM Shift

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 Co

Time Off Program

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions (Simtra) in Bloomington, IN, is seeking a Supervisor, Aseptic Operations to lead a manufacturing team for sterile injectable products. You’ll drive adherence to cGMP, coach staff, and coordinate with Quality, Engineering, and Support groups to meet batch release timelines.

Ideal candidates have a science/engineering/business background, 2+ years of manufacturing experience, and 1+ year of leadership.

Qualifications

• Bachelor's degree in science, engineering, or business preferred.
• Minimum 2 years manufacturing or operations support experience.
• Minimum 1 year leadership experience.
• Proficient with Microsoft Word, Excel, Outlook and enterprise software like Dynamics, Veeva, PowerBI, Trackwise.

Responsibilities

• Understand, follow, coach, and lead teams to execute production activities per cGMP.
• Provide guidance, support, direction and leadership in daily operations.
• Interview, hire, mentor, and develop staff; conduct annual performance reviews.
• Supervise day-to-day production, scheduling, staffing, material management, compliance, training and auditing; strong Gemba presence.
• Review, approve, and manage documentation for batch and system records; assist in product release.
• Implement and support training programs to ensure manufacturing processes comply with cGMP and EHS.
• Develop and implement performance metrics and internal auditing programs; implement changes based on assessments.
• Lead technical reviews, investigations and process improvements; input on integration/validation of new equipment.
• Resolve technical, material and cGMP problems affecting deadlines; provide RCA guidance during deviations.
• Obtain qualification to perform select critical operation processes.
• Represent the company during audits and inspections.
• Bachelor's degree requirement and experience expectations are outlined above.

Skills

Leadership experience

Communication

Gemba presence

Problem solving

Microsoft Office

Education

Bachelor's degree in science/engineering/business

High School diploma or GED

Tools

Microsoft Dynamics

Veeva

PowerBI

Trackwise

Job description

Simtra BioPharma Solutions (Simtra) in Bloomington, IN, is seeking a Supervisor, Aseptic Operations to lead a manufacturing team for sterile injectable products. You’ll drive adherence to cGMP, coach staff, and coordinate with Quality, Engineering, and Support groups to meet batch release timelines.

Ideal candidates have a science/engineering/business background, 2+ years of manufacturing experience, and 1+ year of leadership.