Sr. Scientist I, Combination Products
AbbVie
September 02, 2026
On-site
North Chicago, IL
$96,500 - $183,500 USD yearly
Clinical Research and Development
Responsibilities:
- Technical support of product development and lab-scale-up leadership for commercial manufacturing of medical devices, drug-device delivery systems, and combination products.
- Cross-function engagement and matrix working in drug delivery system product development portfolios.
- Advance scientific/engineering efforts, including experimental DOE design, with internal teams and external partners.
- Support experimental lab execution, data generation/collection, results summaries, and weekly slide presentations.
- Engage cross-functional teams through governance processes; evaluate potential risks and resolve issues timely.
- Support tech transfer, process development, optimization, and scale-up; partner with CMOs for technical/operational alignment.
- Plan, design, execute, document, and analyze tests to evaluate/verify/validate a system.
- Apply knowledge of pharmaceutical manufacturing processes (small molecules and biological drug-related device delivery systems and combination products).
- Develop DOE/functional tests, experimental protocols, and new target evaluations with project/lab teams.
- Assess risks; create test plans; analyze results, draw conclusions, and assess residual risk.
- Apply regulations and guidance for design verification/validation; prepare documentation for SOP compliance.
- Develop/review technical documentation (SOPs, batch records, validation protocols).
- Troubleshoot manufacturing challenges and investigate deviations/process failures.
- Collaborate with marketing, quality, regulatory, and supply chain teams.
- Stay current on industry trends and best practices.
Qualifications:
- Preferred Ph.D. (3–5 years) in device-drug delivery systems/combination products; or MS (5–10 years) in relevant biomedical/mechanical/chemical/materials/biotech/pharma engineering fields.
- Experience developing medical devices, drug-device delivery systems, and/or combination products; product/process design and design verification/validation; patient usability applications.
- Helpful: pre-filled syringe/cartridge, wearable medical devices, auto-injectors, eye care, aesthetics, pumps.
- Plus: Hyaluronic Acid (hydrogel) materials knowledge; wearable device battery (primary/rechargeable) design-material-process-characterization.
- Must have: product development and commercial scale manufacturing knowledge; pharma/medical device development problem-solving.
- Hands-on lab experience with biomedical/mechanical design, drug product stability, primary container chemistry.
- Plus: combination products focused on electro-mechanical pump devices and primary drug-delivery containers.
- Required: strong technical writing, data summaries, technical reports, slide presentations.
- Helpful: FDA/ISO standards, design history file, PMP.
- Excellent problem-solving, communication, and collaboration.
- Technical support of product development and lab-scale-up leadership for commercial manufacturing of medical devices, drug-device delivery systems, and combination products.
- Cross-function engagement and matrix working in drug delivery system product development portfolios.
- Advance scientific/engineering efforts, including experimental DOE design, with internal teams and external partners.
- Support experimental lab execution, data generation/collection, results summaries, and weekly slide presentations.
- Engage cross-functional teams through governance processes; evaluate potential risks and resolve issues timely.
- Support tech transfer, process development, optimization, and scale-up; partner with CMOs for technical/operational alignment.
- Plan, design, execute, document, and analyze tests to evaluate/verify/validate a system.
- Apply knowledge of pharmaceutical manufacturing processes (small molecules and biological drug-related device delivery systems and combination products).
- Develop DOE/functional tests, experimental protocols, and new target evaluations with project/lab teams.
- Assess risks; create test plans; analyze results, draw conclusions, and assess residual risk.
- Apply regulations and guidance for design verification/validation; prepare documentation for SOP compliance.
- Develop/review technical documentation (SOPs, batch records, validation protocols).
- Troubleshoot manufacturing challenges and investigate deviations/process failures.
- Collaborate with marketing, quality, regulatory, and supply chain teams.
- Stay current on industry trends and best practices.
Qualifications:
- Preferred Ph.D. (3–5 years) in device-drug delivery systems/combination products; or MS (5–10 years) in relevant biomedical/mechanical/chemical/materials/biotech/pharma engineering fields.
- Experience developing medical devices, drug-device delivery systems, and/or combination products; product/process design and design verification/validation; patient usability applications.
- Helpful: pre-filled syringe/cartridge, wearable medical devices, auto-injectors, eye care, aesthetics, pumps.
- Plus: Hyaluronic Acid (hydrogel) materials knowledge; wearable device battery (primary/rechargeable) design-material-process-characterization.
- Must have: product development and commercial scale manufacturing knowledge; pharma/medical device development problem-solving.
- Hands-on lab experience with biomedical/mechanical design, drug product stability, primary container chemistry.
- Plus: combination products focused on electro-mechanical pump devices and primary drug-delivery containers.
- Required: strong technical writing, data summaries, technical reports, slide presentations.
- Helpful: FDA/ISO standards, design history file, PMP.
- Excellent problem-solving, communication, and collaboration.