New Product Development Lead Specialist

Key Responsibilities

• Lead, mentor, and develop a multidisciplinary team for the creation and optimization of new compounded sterile preparations (CSPs) and other 503B products.
• Set clear expectations, provide regular feedback, and foster a culture of accountability, continuous learning, and professional growth within the department.
• 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.
• Guide the technical direction of new product development, troubleshooting formulation and manufacturing challenges, and ensuring best practices in sterile compounding and drug manufacturing.
• 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.
• Champion a culture of quality and compliance, ensuring all personnel adhere to cGMP, FDA, and state regulatory requirements for 503B outsourcing facilities.
• Work closely with quality assurance, commercial, and production teams to ensure seamless transfer of new products from development to manufacturing.
• Identify and implement process improvements, new technologies, and training programs to enhance team performance and product quality.
• 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.