Compounding Lead

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 48,000 - 64,000; Full time

Job summary

Fagron Sterile Services US (FSS) is seeking an associate to assist pharmacists and room supervisors in preparing materials and performing manual aseptic filling within an ISO 7 environment.

The role emphasizes maintaining cleanroom SOPs, calibration checks, and adherence to cGMP standards, while providing on-the-floor leadership and coaching to technicians and production staff.

Qualifications

• ISO 7 gowning experience required.
• GDP experience required.
• A strong understanding of cGMP pharmaceutical manufacturing preferred.
• Supervision or lead experience preferred.
• ISO 5 experience preferred.

Responsibilities

• Assist pharmacists and room supervisors in aseptically preparing materials.
• Oversee ISO 7 cleanroom activities and related tasks.
• Support calibration checks and environmental monitoring.
• Ensure compliance with SOPs, batch records and HR policies.
• Promote Right First Time (RFT) by reducing deviations and errors.
• Track training and aid in periodic procedure reviews.
• Provide on-the-floor leadership to production teams.

Skills

ISO 7 gowning

GDP experience

cGMP awareness

lead experience

ISO 5 experience

Job description

Who We Are

Fagron was founded in Rotterdam (The Netherlands) in 1990 and is a dynamic organization with over 3,000 employees worldwide. As the global market leader in personalized medicine, we are highly passionate about being at the forefront of our field. Each day, we are committed to improving the lives of millions of people across the world by optimizing and innovating personalized pharmaceutical solutions.

About the Job

Assist pharmacists and room supervisors to oversee all required activities for the preparation of materials and manual aseptic filling of compounding sterile products within an ISO 7 environment.

Key Responsibilities

• Successfully pass and remain qualified for entrance into the ISO 7 cleanrooms.
• Successfully pass and remain media fill qualified.
• Must be able to stand and maneuver around the tight spaces of a cleanroom for upwards of 7 hours per day.
• Assist in overseeing all ISO 7 cleanroom activities including but not limited to: cleaning of VLFHs, the preparation of materials required to aseptically reconstitute, pool and dilute drug product, manual aseptic filling of drug product, performing calibration checks, environmental plating of operators, and communicating issues with management.
• Ensuring compliance to SOPs, batch records and HR policies, assisting in disciplinary action as needed.
• Meet Right First Time (RFT) metrics by reducing error/deviations and completing corrections quickly.
• Review and maintain adherence to the manufacturing schedules.
• Track employee training to ensure compliance.
• Aid in bi-annual reviews of procedures.
• Provide on-the-floor leadership to the production team.
• Assist in coaching and training of technicians in the manufacturing suites.
• Support process improvements and scale up initiatives within the department.
• Manage personnel to operational standards and assist as needed in completing performance evaluations.

Basic Qualifications

• ISO 7 Gowning experience required.
• GDP experience required.
• A strong understanding of cGMP pharmaceutical manufacturing preferred.
• Supervision or lead experience preferred.
• ISO 5 experience preferred.

What’s on Offer

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organizational culture that values strong motivation and independent work. Fagron is an internationally expanding, professional, and ambitious pharmaceutical company with multiple growth opportunities, offering a competitive salary, comprehensive benefits, a performance package, and the chance to be part of an international leader in an expanding industry.

Ready for the challenge?

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.