About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role:
Provide risk-based assessment and strategy to demonstrate protection, compatibility, safety and performance of device/ packaging components and/or systems with the blow-fill-seal form serving as the primary drug container, the inhalation spray device serving as the secondary packaging for the dispense of the drug constituent as well as any other packaging of the product (i.e., bag, carton/box serving as tertiary packaging of the product).
What You'll Do:
- Develop a preliminary Biological Evaluation Plan (BEP) outlining the proposed strategy for testing.
- Identify the analytical, performance, and toxicological considerations relevant to an inhalation combination product with a primary drug container.
- Define biological evaluation strategy based on product classification, type of medicinal product, each level of packaging material and composition of the device, nature of contact, dosage form, exposure to the patient, duration of exposure, etc.
- Collect requirements pertinent with applicable US FDA regulations
- Collect and review available information on materials of construction, manufacturing processes, process parameters (cleaning steps, sterilization steps), type of medicinal product, dosage form and product use.
- Identify applicable biological endpoints and provide justification for inclusion/exclusion.
- Outline stability and chemical characterization approach
- Establish toxicological evaluation approach, including consideration of exposure thresholds (e.g., SCT)
- Provide a list of tests and studies for establishing suitability and quality control and as applicable, provide justification for any test waivers or use of existing data.
- Complete Biological Evaluation Plan suitable for internal decision-making and regulatory strategy support
What you will bring:
- Bachelor's (7+ years' experience) or Master's PhD (5+ years' experience) in Toxicology, Chemistry, Biomedical Engineering, or Biology, preferred.
- Significant experience in biocompatibility assessment within a medical device environment
- Demonstrated expertise authoring assessments, evaluations, SOPs, and regulatory-facing documents
- Strong working knowledge of FDA-regulated environments and applicable standards (ISO 10993)
- Exceptional technical writing and verbal communication skills, including comfort presenting to senior and executive audiences
- Proven ability to independently own projects and operate as a trusted expert
ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.