New Product Development Lead – Sterile CSPs

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 80,000 - 110,000; Full time

Job summary

Fagron Sterile Services US (FSS) in Wichita, Kansas is searching for a New Product Development Lead Technician. This role focuses on the technical and operational aspects of developing compounded sterile preparations, leading a multidisciplinary team, and ensuring compliance with cGMP and FDA regulations.

The ideal candidate will have a Bachelor's degree in a related field and experience in pharmaceutical product development. Strong leadership and interpersonal skills are essential to mentor staff and drive process improvements.

Qualifications

• Minimum 3 years of experience in pharmaceutical product development, plus 1-2 years in a team leadership role.
• Experience managing teams in cleanroom environments with knowledge of cGMP.
• Demonstrated knowledge and hands-on experience with stability studies.

Responsibilities

• Lead and develop a multidisciplinary team for the optimization of new compounded sterile preparations.
• Ensure compliance with cGMP, FDA, and state regulations for outsourcing facilities.
• Coordinate and oversee stability studies for new and existing products.

Skills

Team Leadership & Development

Performance Management

Technical Oversight

Quality & Compliance Advocacy

Cross‑Department Collaboration

Continuous Improvement

Education

Bachelor's degree in pharmaceutical sciences, chemistry, biology, engineering, or a related field

Job description

Fagron Sterile Services US (FSS) in Wichita, Kansas is searching for a New Product Development Lead Technician. This role focuses on the technical and operational aspects of developing compounded sterile preparations, leading a multidisciplinary team, and ensuring compliance with cGMP and FDA regulations.

The ideal candidate will have a Bachelor's degree in a related field and experience in pharmaceutical product development. Strong leadership and interpersonal skills are essential to mentor staff and drive process improvements.