Drug Delivery Product Development Engineers

• BS degree as minimum requirements of 1-5 years, MS preferred 0-3 yrs, PhD acceptable in 0-3 yrs with a degree in the field of biomedical, mechanical, chemical, materials science and engineering, biotechnology and pharmaceutical related engineering fields.
• experiences in medical devices, drug delivery systems, scientific investigation, lab experimental, capability of problem solving in problems solving for solutions,
• Hand-on experience with lab study related to biomedical and mechanical design and development, drug product stability and chemical reactions in primary containers.
• Experience in multiple Combination Products with the focus on electro-mechanical pump devices and primary containers for drug delivery, Excellent technical writing skills, data summary, technical report, slide presentation are required
• Product development experience and commercial scale manufacturing knowledge are preferred.
• Experience in developing medical devices, device-drug delivery systems, and/or combination products. Broad experience in product and process design, development, design verification and design validation and patient usability applications.
• Product development experience and commercial scale manufacturing knowledge are a must have. Strong understanding of electromechanical device development and process techniques, including design, development, lab testing, and drug-device interaction and system testing.
• Familiarity with cGMP, regulatory requirements (FDA, EMA), and quality assurance practices in medical device, drug-device systems and combination products biomanufacturing.
• Hands-on experience working with contract manufacturing organizations (CMOs) requirements is a plus.

Job Description:

• Technical support of produce development and leadership at lab study scale up for commercial manufacturing of medical devices, drug device delivery systems, and combination products.

• Cross-function engagement and team matrix working experiences in portfolios of drug delivery system product development projects.

• Advances in scientific and engineering of medical device related experimental DOE design of experimental activities for the engagements with internal teams and external partners.

• Supports the experimental lab execution, data generation and collection, results summary and slide deck preparation and presentation at weekly meeting.

• Interface engagement of the project cross-function team and governance process and forward-looking evaluation of potential risk with timely problem solving.

• Supports in tech transfer, process development, optimization, and scale-up activities. Work closely with contract manufacturing organizations (CMOs) to ensure technical and operational alignment with company standards.

• Plans, designs, executes, documents, and analyzes a regimen of tests to evaluate, verify and/or validate a system.

• Provide knowledge in pharmaceutical manufacturing processes, particularly small molecules and biological drug related device delivery systems and combination products

• Interface with project and laboratory teams to develop DOE and functional tests, experimental protocols, and new target evaluations.

• Assesses risks and creates test plans around risk priorities; analyzes results, states conclusions, and assesses residual risks after tests are complete; in addition, assesses adequacy of support for conclusions by test results.