Aseptic Operations Supervisor – Pharma Manufacturing

Simtra BioPharma Solutions; Bloomington (CA); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Medical & Dental

401(k) Plan

Paid Holidays

Paid Time Off

Parental Leave

Education Assistance

Employee Assistance

Employee Ownership

Disability Insurance

Vision Coverage

Identity Theft Protection

Job summary

Simtra BioPharma Solutions seeks a Supervisor, Aseptic Operations to lead a manufacturing team in sterile injectable production. You will ensure compliance with cGMP, batch records, and release timelines while coordinating with Quality, Engineering and Support departments.

You will mentor staff, review performance, manage documentation, and drive training, audits and process improvements on the shop floor. This role reports to the Manager, Aseptic Operations and is part of the Operations

Qualifications

• Bachelor’s degree in science, engineering, or business strongly preferred; high school diploma or GED required.
• Minimum 2 years of manufacturing or operations support experience strongly preferred
• Minimum 1 year of leadership experience required.
• Proficiency in Microsoft Word, Excel, Outlook, and enterprise systems such as Microsoft Dynamics, Veeva, PowerBI, or TrackWise.

Responsibilities

• Understand, follow, coach, and lead their 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 in order 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

Communication

Problem-solving

Mentoring

Gemba presence

Education

Bachelor’s degree in science, engineering, or business

Tools

Microsoft Dynamics

Veeva

PowerBI

TrackWise

Job description

Simtra BioPharma Solutions seeks a Supervisor, Aseptic Operations to lead a manufacturing team in sterile injectable production. You will ensure compliance with cGMP, batch records, and release timelines while coordinating with Quality, Engineering and Support departments.

You will mentor staff, review performance, manage documentation, and drive training, audits and process improvements on the shop floor. This role reports to the Manager, Aseptic Operations and is part of the Operations