Director of Technical Services & Application Development

The Director of Technical Services & Application Development is responsible for leading customer-facing technical support, application development, and product implementation activities for pharmaceutical and medical packaging solutions. This role serves as the technical authority bridging customers, sales, manufacturing, quality, and R&D, ensuring packaging systems meet regulatory, functional, and performance requirements across sterile, non-sterile, and medical device applications.

The position requires deep expertise in pharmaceutical and medical packaging materials, processing technologies, validation practices, and global regulatory expectations, combined with strong leadership and cross-functional collaboration skills.

Key Responsibilities

Technical Services Leadership

• Lead and develop a multidisciplinary technical services and application development team supporting pharmaceutical, biotech, and medical device customers.
• Provide expert technical guidance on packaging system selection, material compatibility, barrier performance, sterilization compatibility, and processing robustness.
• Serve as the escalation point for complex technical issues, deviations, complaints, and field performance concerns related to packaging applications.
• Establish standardized technical service processes, documentation, and response protocols aligned with GMP and quality system requirements.

Application Development & Product Implementation

• Oversee application development activities for new and existing packaging solutions, including customer trials, line qualifications, and scale-up activities.
• Partner with customers to define packaging requirements and translate them into validated, manufacturable solutions.
• Support new product introductions (NPI), including design for manufacturability, performance testing, and lifecycle management.
• Ensure alignment between application development, manufacturing capabilities, and quality/regulatory expectations.

Regulatory, Quality & Compliance Support

• Provide technical input for regulatory submissions, including DMFs, technical dossiers, and customer filings.
• Support audits, inspections, and customer assessments by serving as a subject matter expert for packaging systems, materials, and processes.
• Ensure technical services activities comply with applicable standards and regulations, including FDA, EMA, ISO 11607, ISO 15378, USP, and relevant pharmacopeial requirements.

Cross-Functional Collaboration

• Act as the primary technical interface between Sales, Marketing, Manufacturing, Quality, and R&D teams.
• Support commercial teams with technical presentations, customer meetings, and proposal development.
• Drive alignment between customer needs and internal technology roadmaps.

Strategy & Continuous Improvement

• Contribute to the long-term technical and application strategy for pharmaceutical and medical packaging platforms.
• Monitor industry trends, emerging technologies, and evolving regulatory requirements to inform innovation and service offerings.
• Lead continuous improvement initiatives related to application development efficiency, technical risk reduction, and customer satisfaction.

Required Qualifications

Education

• Bachelor’s degree in Engineering, Materials Science, Polymer Science, Chemistry, or a related technical discipline required.
• Advanced degree (Master’s or PhD) preferred.

Experience

• Minimum of 10–15 years of progressive experience in pharmaceutical or medical packaging, with significant exposure to customer-facing technical roles.
• Demonstrated leadership experience managing technical, engineering, or application development teams.
• Proven track record supporting pharmaceutical, biotech, and/or medical device customers in regulated environments.

Technical Expertise

• Strong knowledge of pharmaceutical and medical packaging systems (e.g., primary packaging, barrier materials, closures, flexible and rigid packaging).
• Experience with sterilization methods (e.g., EtO, gamma, e-beam, steam) and material compatibility considerations.
• Familiarity with packaging validation, performance testing, and risk management methodologies.
• Working knowledge of global regulatory and quality standards relevant to pharmaceutical and medical packaging.

Skills & Competen