Summary

Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Independent business leader, strong team leading skills, no direct personnel supervision. Liaisons with key stakeholders across the organization and external OEMs to realize successful outcomes. The Director will represent the RTC in client-facing technical discussions, proposal development, and program governance, translating complex device engineering activity into clear risk, timeline, and investment narratives for pharma partners.

Job description

Essential Duties and Responsibilities

Lead translation of customer User Needs (UN) into a defined container closure and device strategy, aligned to dosing, patient population, and route of delivery.
Own Label & Packaging design activities, including DFM (Design for Manufacturability) of packaging and linkage with the Design Lab for concept development and iteration.
Direct device assembly and test process design, from concept samples through DV (Design Verification) samples.
Define and deploy scale-appropriate automation strategy, ensuring solutions are right-sized to program volume and maturity (clinical vs. commercial scale).
Establish assembly in-process control and inspection concepts to ensure consistent build quality.
Oversee metrology strategy supporting lot release and regulatory submission data packages.
Drive a “Right First Time” validation philosophy, ensuring DFM interventions remove sources of variability prior to Qualification (Qual) activities.
Embed and maintain ISO 14971 risk management across the full product life cycle, from development through post-market.
Provide technical leadership for regulatory strategy, and support 510(k) and combination product submissions in partnership with Regulatory Affairs and QA.
Lead cross-functional device RCA investigations, applying in-depth device knowledge, high-speed camera analysis, CT scan, and X-ray imaging techniques to diagnose functional and mechanical failures.
Translate RCA findings into robust control plans aligned to ISO 14971 risk management principles.

Supervisory Responsibilities

Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Independent business leader, strong team leading skills, no direct personnel supervision. Liaisons with key stakeholders across the organization and external OEMs to realize successful outcomes. The Director will represent the RTC in client-facing technical discussions, proposal development, and program governance, translating complex device engineering activity into clear risk, timeline, and investment narratives for pharma partners.

Requirements

Bachelor's degree in Mechanical, Electronic, Biomedical, or Manufacturing Engineering (advanced degree preferred).
5+ years' experience in combination product / drug delivery device development, with at least 3 years in a senior leadership role.
Demonstrated expertise in autoinjector, pen injector, or needle safety device design, assembly, and industrialization.
Strong working knowledge of ISO 11608, ISO 11040, ISO 14971 and the Metrology equipment to meet it, ISTA/ASTM transport standards, and design controls (DHF/DMR).
Experience supporting 510(k) submissions and combination product regulatory pathways (FDA, EU MDR/CTR as applicable).
Track record of building or leading a technical center, lab, or center of excellence supporting external pharmaceutical clients.
Hands-on familiarity with root-cause investigation tools (CT scan, X-ray, high-speed imaging) and automation/tooling program management.
Strong client-facing communication skills; comfortable operating at both technical depth and executive summary level.
Able to translate customer feedback into meaningful product solutions, is a self-motivated multitasker with high attention to detail.
Track record in developing and executing product launches.
Efficient with a focus on timelines & due dates.
Preferred: Experience with device platform partnerships and managing external SME networks.
Preferred: Familiarity with DFM/DFA methodologies and statistical process control in a regulated manufacturing environment.
Preferred: Experience managing multi-program portfolios across clinical and commercial stage clients simultaneously.

Company overview

PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.