Sr. Scientist I, Combination Products

BioSpace; North Chicago (IL); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie seeks a highly capable science/engineering professional to conceive and implement novel experimental approaches and optimize new methods for drug-device delivery systems. You will develop productive collaborations across science disciplines and support lab-to-manufacturing transitions.

You will contribute to project science, design verification/validation, and documentation while engaging with internal teams and external partners to solve complex challenges in a fast-paced environment.

Qualifications

• PhD preferred with 3–5 years in device-drug delivery systems and combination products.
• Experience in medical devices, device-drug delivery and combo products.
• Strong knowledge of design verification and design validation.
• Experience with lab study related to biomedical and mechanical design.
• FDA/ISO knowledge and GMP mindset is desirable.

Responsibilities

• Provide technical support for lab study scale-up and commercial manufacture readiness.
• Engage cross-functionally with teams across science, quality and regulatory.
• Develop and evaluate DOE protocols and experimental plans.
• Prepare data, summaries and slide decks for weekly reviews.
• Triage risks, document test plans and determine residual risk mitigations.
• Collaborate with CMOs to ensure alignment with company standards.
• Develop technical documentation including SOPs, batch records and validation protocols.

Skills

Strong communication

Problem solving

Technical writing

Team collaboration

Lab methods

Education

PhD preferred

MS with 5–10 years

Tools

PMP

Design of experiments (DOE)

Design verification

Design validation

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

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.

Responsibilities

• Technical support of produce develop ment 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.

Qualifications

• Preferred Ph.D. degree with 3-5 years of industry working experience in device-drug delivery system and combination product is preferred; post-doctor experience and high quality of Ph.D. candidates, and/or MS with 5-10 years of working experience in the field of biomedical, mechanical, chemical, materials science and engineering, biotechnology, and pharmaceutical and other related engineering fields.
• 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.
• 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.
• 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.
• FDA and ISO standards, design history file, project management professional (PMP) experience will be helpful.
• 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.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html