Senior Scientist II

Company Description

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on Linked In, ()  Facebook, Instagram () , X ()  and You Tube () .

Job Description

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 Abb Vie's rapidly growing medical aesthetics portfolio, with a primary focus on dermal fillers.

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+ Draft guidance documentation such as work instructions, master batch records, and protocols.

+ Analyse 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.

+ Participate, and present in project team meetings to propose project activities, review completed tasks, and technical progress as needed.

+ Write, review and issue batch records, build packages, reports, memoranda, and other documents for internal and external distribution.

+ Generate ROI's and works closely with corporate patent counsel in generating IP documentation.

+ Remain as an internal technical consultant through the entire product development life cycle.

+ Transfer manufacturing processes to/from internal and/or external manufacturing sites.

+ Search, review, and evaluate current literatures and relevant technology landscape to help maintain and extend internal technical competence.

+ Attend and participate in scientific meetings as company's representative to gain knowledge about new products or technologies pertinent to corporate business interest.  

+ Communicate and recommend new biomaterial, product, and technology related ideas to supervisor and other research managers to maintain and enhance company's position in the marketplace.

Qualifications

+ 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. Preferably with a Ph.D. degree.

+ Possess thorough theoretical and practical understanding of own scientific discipline.

+ Effective writer and communicator of research and regulatory materials.

+ Work experience involving medical device and combination products is preferred.

+ Advanced technical competence and expertise in guidance and execution of manufacturing processes.

+ Ability to automate manufacturing processes using existing or newly proposed capabilities.  

+ Demonstrated critical thinking and problem-solving skills and good communication skills, both oral and written.

+ Working knowledge of…