New Product Development Lead Specialist

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

About the Job

The successful candidate will have the ability to work in a fast‑paced pharmaceutical manufacturing environment, make decisions, and is capable of setting and balancing priorities. Manage multiple tasks, projects with frequent changes and manage product validation activities with cross‑functional partners at all levels in the organization.

Willingness to perform hands‑on work and manage teammates, consultants, and contractors executing metrology and validation activities throughout the facility.

The New Product Development Lead Technician oversees the technical and operational aspects of developing new compounded sterile preparations, leading a multidisciplinary team through formulation, stability studies, and scale‑up activities in compliance with cGMP and FDA 503B regulations. The role is responsible for mentoring staff, managing cleanroom competencies, and driving process improvements to enhance product quality and team performance. The technician also serves as a key liaison across departments to ensure seamless transfer of products from development to commercial manufacturing.

Key Responsibilities

• Team Leadership & Development: Lead, mentor, and develop a multidisciplinary team for the creation and optimization of new compounded sterile preparations (CSPs) and other 503B products.
• Performance Management: Set clear expectations, provide regular feedback, and foster a culture of accountability, continuous learning, and professional growth within the department.
• Resource Planning: Assess staffing needs, participate in recruitment and onboarding, and ensure adequate training and competency of team members in cleanroom operations, aseptic technique, and cGMP compliance.
• Technical Oversight: Guide the technical direction of new product development, troubleshoot formulation and manufacturing challenges, and ensure best practices in sterile compounding and drug manufacturing.
• Stability Study Coordination: Oversee, coordinate, and delegate tasks related to the planning, execution, and documentation of stability studies for new and existing products, ensuring compliance with regulatory requirements and timely completion of deliverables.
• Quality & Compliance Advocacy: Champion a culture of quality and compliance, ensuring all personnel adhere to cGMP, FDA, and state regulatory requirements for 503B outsourcing facilities.
• Cross‑Department Collaboration: Work closely with quality assurance, commercial, and production teams to ensure seamless transfer of new products from development to manufacturing.
• Continuous Improvement: Identify and implement process improvements, new technologies, and training programs to enhance team performance and product quality.
• Stakeholder Engagement: Serve as a key point of contact for internal leadership and external partners regarding personnel capabilities, departmental achievements, and resource needs.

Basic Qualifications

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

Minimum 3 Year Of Experience In Pharmaceutical Product Development, plus an additional 1‑2 years in a personnel management, supervisory, or team leadership role preferably in sterile compounding, 503B outsourcing, pharmacy, or related cGMP environments.

Proven experience managing teams in cleanroom environments, with strong knowledge of cleanroom operations, aseptic technique, and contamination control.

In-depth understanding of drug manufacturing processes, including formulation, batch production, quality control, and batch release in a cGMP‑regulated setting.

Demonstrated knowledge and hands‑on experience with stability studies, including study design, execution, data interpretation, and regulatory documentation.

Deep knowledge of 503B outsourcing facility regulations, cGMP, and FDA requirements for compounded sterile preparations.

Demonstrated ability to coach, motivate, and develop high‑performing teams.

Strong communication, interpersonal, and conflict resolution skills.