Senior Scientist II

AbbVie•Irvine, CA

8d•$109,500 - $208,500

About The Position

The Senior Scientist II will lead the development and site transfer of manufacturing processes for next-generation medical aesthetics products. This role is responsible for designing, planning, executing, documenting, and interpreting scientific experiments in collaboration with a team of scientists and engineers. The position also requires strong cross-functional partnership with internal and external stakeholders, along with excellent communication and presentation skills. The processes and capabilities developed by the Senior Scientist will follow design of experiments principles to support the consistent production of finished products that meet critical quality attributes. This is a high-impact role that directly supports AbbVie’s rapidly growing medical aesthetics portfolio, with a primary focus on dermal fillers.

Requirements

BS (12+ years industry), MS (10+ years industry) or Ph.D. (4+ years industry) in Biomedical Engineering, Biomaterials Science, Materials Engineering, Bioengineering, Chemical Engineering, or related fields.
Possess thorough theoretical and practical understanding of own scientific discipline.
Effective writer and communicator of research and regulatory materials.

Nice To Haves

Preferably with a Ph.D. degree.
Work experience involving medical device and combination products is preferred.

Responsibilities

Scale up and develop manufacturing processes of novel medical devices with the goal of improving process robustness and transferability.
Lead execution of manufacturing processes such as solution preparation, synthesis, purification, sterile filtration, compounding, terminal sterilization and product filling in primary packaging.
Draft guidance documentation such as work instructions, master batch records, and protocols.
Analyze experimental data generated by the analytical team, to better understand and also improve process capability where needed.
Collaborates with global cross functional partners on joint experimental studies to achieve common project goals.
Prepare and review design of experiments to better understand product critical process parameters and proven acceptable ranges.
Maintain a high level of productivity in the lab.
Participates, and presents in project team meetings to propose project activities, review completed tasks, and technical progress as needed.
Writes, reviews and issues batch records, build packages, reports, memoranda, and other documents for internal and external distribution.
Generates ROI’s and works closely with corporate patent counsel in generating IP documentation.
Remains as an internal technical consultant through the entire product development life cycle.
Transfer manufacturing processes to/from internal and/or external manufacturing sites.
Searches, reviews, and evaluates current literatures and relevant technology landscape to help maintain and extend internal technical competence.
Attends and participates in scientific meetings as company’s representative to gain knowledge about new products or technologies pertinent to corporate business interest.
Communicates and recommends new biomaterial, product, and technology related ideas to supervisor and other research managers to maintain and enhance company’s position in the marketplace.