Sr. Scientist I, Combination Products

AbbVie•North Chicago, IL

5d•$96,500 - $183,500

About The Position

Conceive and implement novel experimental approaches to answer scientific questions. Investigate, identify, develop, and optimize new methods and techniques. Contribute to project science in area of expertise. Develop productive collaborations and communications with other groups across science disciplines.

Requirements

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 pharma or medical device product development and capability of problem solving to unique problems with solutions.
Hands-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 to the patient for disease therapies.
Excellent technical writing skills, data summary, technical report, slide presentation are required.
Excellent problem-solving skills and ability to work in a fast-paced environment.
Strong communication and collaboration skills to effectively engage with internal and external stakeholders.

Nice To Haves

Prior experience and knowledge of pre-filled syringe and cartridge, wearable medical devices (OBDS), auto injectors, eye care, or eye droppers, aesthetics, and pumps will be helpful.
Knowledge and experience in Hyaluronic Acid (HA) materials in hydrogel family in the manufacturing process and material characterization are the plus for candidates to meet the requirements.
Knowledge and experience in wearable device battery (primary and rechargeable) in the design-material-process-characterizations are the plus for candidates to meet the requirements.
FDA and ISO standards, design history file, project management professional (PMP) experience will be helpful.

Responsibilities

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.
Understands regulations, apply guidance and standards on design verification and design validation to test activities and work products; prepares documentation for compliance with standard operating procedures.
Develop and review technical documentation, including standard operating procedures (SOPs), batch records, and validation protocols.
Troubleshoot manufacturing challenges and support investigations into deviations or process failures.
Collaborate cross-functionally with marketing, quality, regulatory, and supply chain teams to ensure seamless operations.
Stay up to date with industry trends and best practices in pharmaceutical product development and lab, pilot and scale up manufacturing and commercial production.