Aseptic Operations Leader - cGMP & Team Growth

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with公司匹

Paid Holidays

Paid Time Off

Parental Leave

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Supervisor, Aseptic Operations to lead a manufacturing team producing sterile injectables under cGMP. You will ensure compliance with batch records, coach staff, oversee scheduling, and drive continuous improvement on the shop floor.

Ideal candidates have a science/engineering/business degree, 2+ years in manufacturing, 1+ year leadership, and proficiency with Microsoft Office and enterprise systems (e.g., Dynamics, PowerBI).

Qualifications

• Follow cGMPs and EHS regulations in all manufacturing activities.
• Lead, mentor and develop staff with objective setting and performance reviews.
• Review, approve and manage batch and system documentation and records.

Responsibilities

• Understand, follow, coach, and lead teams to execute production activities per cGMP.
• Provide guidance, support, and leadership during daily operations.
• Interview, hire, mentor, and conduct annual performance reviews for direct reports.

Skills

Leadership

Gemba presence

Problem solving

Education

Bachelor's Degree (science/engineering/business)

High School diploma or GED

2+ years manufacturing or operations experience

1+ year leadership experience

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Microsoft Dynamics

PowerBI

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Supervisor, Aseptic Operations to lead a manufacturing team producing sterile injectables under cGMP. You will ensure compliance with batch records, coach staff, oversee scheduling, and drive continuous improvement on the shop floor.

Ideal candidates have a science/engineering/business degree, 2+ years in manufacturing, 1+ year leadership, and proficiency with Microsoft Office and enterprise systems (e.g., Dynamics, PowerBI).