Job Description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Key Responsibilities

• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
• 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.
• 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.
• 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
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.

Knowledge / Skills & Experience

Essential:

• Bachelor’s degree in Mechanical, Electronic, Biomedical, or Manufacturing Engineering (advanced degree preferred).
• 10+ 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

Desirable:

• Experience with device platform partnerships and managing external SME networks.
• Familiarity with DFM/DFA methodologies and statistical process control in a regulated manufacturing environment.
• Experience managing multi-program portfolios across clinical and commercial stage clients simultaneously.

#LI-MS1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.