New Product Development Lead Specialist

Who We Are

Since 1990, we’ve grown into a global leader in personalized medicine. Today, our 5,000 energetic employees are based in 80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide.

From compounding and natural products to software, equipment, and genomics — we deliver smart, ready-to-use solutions that make healthcare better.

We’re passionate, science-driven, and always looking for new ways to improve lives. 🚀

Explore your future at Fagron Career Site.

About The Job

The successful candidate will have the ability to work in a fast-pace 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. This 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, troubleshooting formulation and manufacturing challenges, and ensuring 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 years 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.
• Experience with advanced technologies (automation, data analytics) in pharmaceutical manufacturing is highly desirable.
• Commitment to fostering a culture of safety, compliance, and continuous improvement.
  
  

What's on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready for the challenge?

We’re proud to be an equal opportunity employer. 🌍 Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

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.