Sr. Biological Research Scientist - Device

Company: AbbVie
Location: Irvine
Posted on: August 4, 2022

Job Description:

Allergan Aesthetics, Device Biology R&D, is seeking a Senior Scientist who will provide highly skilled scientific and experimental support to R&D project teams for Pre-Concept, New Product Development, and/or Performance Teams supporting our Plastic Surgery/Breast Surgery franchise. Under minimal supervision, this individual will be expected to independently develop, perform, and analyze in vitro, in vivo (animal-based testing), and/or ex vivo safety and efficacy evaluations of cell/tissue interactions with novel silicone-based medical devices, possibly in conjunction with other biomaterials- or cell/tissue-based products for plastic surgery/breast surgery applications. Additional responsibilities include developing technical strategies and overseeing the design and execution of studies utilizing a variety of cell & molecular biology and/or material characterization techniques including, but not limited to, animal surgery, live imaging, cell culture, microscopy, PCR, ELISA, histology, flow cytometry evaluation of cells and tissues, and material characterization. Additional day-to-day activities will include mentoring junior scientific team members, staying current with literature/scientific advances in the relevant therapeutic area(s), and lab development activities. Experience with managing outsourced research activities is required. Previous experience with biomaterials and/or silicone-based materials is a plus. A proven track record of being able to lead projects and mentor/influence key stakeholders is also a plus. Creativity, acute attention to detail, strong communication skills, as well as the ability to successfully operate independently and as part of a team-based environment is crucial.
Responsibilities:
Manages and leads model development/pre-concept/development/post-market performance efforts to evaluate device efficacy. Identifies opportunities for new methods or product concepts and engages and manages outside contractors to support testing as necessary. Works as scientific/technical/activity lead to support new product ideation and development. Additionally, may mentor/train junior staff
Responsible for creating detailed project plans including scientific hypothesis-driven strategy and realistic deliverables with timelines. Actively involved in the planning, execution, and management of experimental studies for characterization of the safety and efficacy of novel and existing products
Actively works in a team environment. Frequent communication is essential and must interface with colleagues in Device Biology Research and Product Development, as well as other departments such as Regulatory Affairs and Medical Affairs. Serves as functional representative on core teams or Product Development sub-teams, providing expertise in areas of tissue response to implantable materials for Pre-Concept, Development, and/or Performance Teams and responsible for supporting Design Control activities as the non-clinical representative
Organizes, schedules, and participates in project team meetings to define and schedule project activities and review completed tasks. Communicates project status to supervisor, project team leader, other research managers, and R&D committees as appropriate. Prepares time and cost estimates of project activities to achieve realistic project completion dates
Write, review, and issue technical reports, technical memoranda, and other documents for internal and external distribution. Also prepares data summaries from lab studies for dissemination of information in scientific and management presentations. Works closely with Allergan patent counsel in generating IP documentation. Publish technical articles that are consistent with the goals of the organization
Ph.D. and 4+ years of industry experience or Master's degree and 7+ years of industry experience. Degree in a related scientific or engineering discipline (molecular cell biology, immunology, biomedical engineering, materials/polymer science, or similar)
Prior experience in a medical device or pharmaceutical company or related setting with a proven record of success in conducting R&D projects
Ability to work independently, set priorities, and handle multiple tasks with a high degree of efficiency
Proven track record of designing and executing on scientific hypothesis-driven research and creative problem-solving
Capable of delivering complex technical information in a clear and easy-to-understand manner both in writing and verbally through presentations, technical reports, manuscripts, and IP submissions
Experience conducting in vivo research and willingness to perform in vivo, ex vivo, and in vitro research activities required
Experience managing outsourced GLP and non-GLP research activities required.
Proficiency in mentoring junior staff and serving as a senior technical advisor required
Prior experience with medical device Product Development, including Design Controls, is a plus
Hands-on experience with performing small and large animal surgeries is a plus
Experience with silicone-based biomaterials and/or mechanical engineering background is a plus
Knowledge of design, fabrication, and characterization of biological and synthetic biomaterials (e.g., biochemical, biophysical, and structural properties) is a plus
In addition, the successful candidate will liaise with Marketing, Regulatory, and Medical Affairs representatives to develop and execute scientific publication and presentation strategies for current products. Creativity, strong scientific leadership skills, an ability to mentor and influence effectively, and acute attention to detail are essential skills for this position.
PDN-ABV2114468

Keywords: AbbVie, Irvine , Sr. Biological Research Scientist - Device, Other , Irvine, California