Project Manager, Operations
$96.5k - $183.5kAbbVie
Senior Scientist I/Development Engineer
We are looking for an experienced and versatile Senior Scientist I/Development Engineer to join our Injection Device Development team to help us accelerate AbbVie's combination products from proof-of-concept through submission, industrialization and launch.
Our team has end-to-end accountability for commercial development, submission, industrialization and marketed product support for injection devices that enable the delivery of AbbVie's innovative medicines. In the course of our work, we collaborate with early-stage CMC, Quality Assurance, Regulatory Affairs, Internal and External Manufacturing, and other cross-functional colleagues to ensure timeliness, robustness and market success.
As a Senior Scientist I/Development Engineer at AbbVie you will be part of a multi-disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. The problems you would help to solve relate not only to the function of innovative injection systems, but also the way in which they interact with drug products and the human body. You would be responsible for advancing programs that combine proven delivery systems with viable commercial drug assets. If you are a self-motivated person who thrives on solving complex problems and are excited by the idea of putting life-changing therapies in the hands of patients, this might be the opportunity for you.
Key Responsibilities:
- Design and execute laboratory studies supporting product development and on-market investigations
- Develop new and maintain existing test methods
- Create and execute test method validation/transfer protocols, and author validation reports
- Maintain product design documentation
- Support design transfer and industrialization activities
- Support design changes and continuous improvement effort
- Perform 3D and 2D CAD development in PDM environment
- Collaborating with third party developers and suppliers
- Position required up to 25% of travel time
Qualifications:
- BS in Mechanical or Biomedical Engineering (MS preferred, PhD aspirational)
- 10 years of experience (MS and typically 8 years, PhD and no experience) ideally in the medical device, drug delivery or other regulated industry
- Strong communication skills (both written and verbal)
- Strong design and analytical skills
- Experience with:
- Laboratory environment, experiment planning, material control and recordkeeping
- Physical prototyping (including 3D printing, manual machining, etc)
- Electro-mechanical devices
- 3D CAD modeling, detailed engineering drawings, product database management environment and GD&T
- Technical protocol and report writing
- Statistical analysis tools
- Manufacturing processes
- Design controls (in accordance with ISO 13485 / CFR 820.30)
- Toolroom environment
- Knowledge of material properties, material selection and testing methodologies
- The ability to create and manage schedules for sub-tasks and work streams for which you are responsible
- A keen eye for identifying project risks and proactively developing mitigation plans
Additional Information:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
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.
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Pay Range: $96500 - 183500 USD
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