Director of Technical Services & Application Development

TekniPlex•Holland, OH

About The Position

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.

Requirements

Bachelor’s degree in Engineering, Materials Science, Polymer Science, Chemistry, or a related technical discipline required.
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.
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.
Strong leadership, coaching, and organizational development capabilities.
Excellent communication skills with the ability to convey complex technical concepts to diverse audiences.
Strategic thinker with a customer-focused mindset.
Ability to manage multiple priorities in a fast-paced, regulated environment.

Nice To Haves

Advanced degree (Master’s or PhD) preferred.

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.