Sr. Scientist I, Combination Products

Role: Lead technical development and support for medical device and drug device delivery systems within biopharma manufacturing. Objectives include optimizing product and process development, supporting scale-up and tech transfer, and ensuring compliance with regulatory standards. Responsibilities encompass experimental design, data analysis, troubleshooting manufacturing challenges, and cross-functional collaboration with quality, regulatory, marketing, and supply chain teams. The role involves hands-on lab work, process validation, risk assessment, and documentation in line with FDA and ISO standards. Qualifications: Ph.D. with 3-5 years in device-drug delivery systems or a related field, or MS with 5-10 years of industry experience in biomedical, mechanical, chemical, or materials sciences. Expertise in medical device development, especially combination products like wearable devices, auto-injectors, or pre-filled syringes, is preferred. Knowledge of hydrogel materials, battery design, and primary containers for drug delivery is advantageous. Strong technical writing and problem-solving skills are required. High-value biopharma specifics include experience with product development, process validation, and manufacturing scale-up for combination products in immunology, oncology, or neuroscience. Collaboration spans internal teams and external CMOs, with an emphasis on regulatory compliance and innovative experimental approaches.