Drug Product and Sterilization Technical Lead

The Drug Product and Sterilization Technical Lead is responsible for providing technical support for the UVADEX drug and sterilization of single-use kits, ensuring continued product quality, compliance, and supply reliability. This role combines expertise in drug product support with sterilization of disposable medical devices (EtO), requiring a understanding of combination products. The engineer will lead issue resolution, drive continuous improvement, and partner across functions to maintain compliant, robust, and efficient processes.

Skills:
The ideal candidate will have a strong background in sterile drug product manufacturing (small molecule sterile drug), terminal sterilization (EtO preferred), materials compatibility, process validation, root cause analysis, risk management, Lean Six Sigma problem-solving, strong written and verbal communication. The role requires excellent problem-solving skills, the ability to manage documentation and validations in a regulated setting, and strong collaboration and communication skills across internal functions and external partners.

Experience:

• Minimum of 5 years’ experience in manufacturing or technical role supporting manufacturing, focused in the pharmaceutical, medical device, or combination product industry.
• Experience in successful completion of technical projects.

Preferred Experience:
Prior experience with drug development/production and/or sterilization of single-use devices strongly preferred ideally with direct exposure to CMOs.

Education:

• Bachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, Microbiology or related discipline required. Advanced degree preferred.
• Provide technical engineering support for UVADEX drug.
• Provide sustaining and continuous improvement for sterilization processes of both drug and disposable/single use kits (ETO).
• Lead issue resolution related to drug/device interactions, sterilization, and product performance.
• Support drug product technical transfers including production line and room qualifications.
• Support EtO sterilization validations, revalidations, and material compatibility studies.
• Partner with Quality, Manufacturing, and Regulatory to ensure compliance with FDA, EMA, and ISO requirements.
• Drive continuous improvement initiatives across drug and device processes. Collaborate with suppliers and contract manufacturers to resolve technical challenges.
• Support lifecycle management, design changes, and risk assessments for drug and kit components.
• Prepare technical documentation, validation protocols, and reports in compliance with cGMP and ISO 13485

Job Benefits:

• Medical, Dental, Vision Insurance
• Life/AD&D
• Short- and Long-Term Disability
• 401(K) with large company match
• Health Saving Account (HSA) and Flexible Spending Account (FSA) with company match
• Wellness Program
• Employee Assistance Program (EAP)
• Generous Paid Time Off (PTO)

Job Type: Full-time

Pay: From $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: Hybrid remote in Radnor, PA 19087

Salary : $100,000