Senior Scientist I Full-time

Senior Scientist

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

Purpose:

The PDS&T Parenterals/Eye Care group is seeking a motivated Senior Scientist to design innovative formulations and develop robust manufacturing processes for clinical phase and commercial products of ophthalmic drug products. This person will apply scientific principles as well as QbD and DoE approaches to systematically design and conduct scientific experiments and provide critical analysis and interpretation of the data, conduct studies in the area of formulation and process development in support of product innovation and life-cycle management of marketed products. This position will be an integral part of the product development and CMC teams and is highly collaborative across functions such as analytical, microbiology, device engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs, supply chain and Operations manufacturing sites.

Responsibilities:

• Plans, directs, and executes formulation and process development activities in support of development of new eyecare products intended for clinical trials and commercialization.
• Conducts research on polymeric materials, formulation sciences, and manufacture technologies in support of innovative product and process development and life-cycle management of marketed products.
• In concert with QA and Manufacturing Support groups, coordinates the activities required to scale-up and transfer new process from pilot-scale to clinical and commercial-scale at the designated site of manufacture.
• Provides scientific and technical leadership on one or more areas of formulation sciences and manufacture technologies. Develops and maintains a current basic knowledge of global CMC regulatory submission requirements, GLP/GMP requirements & device regulations (ISO). Reviews internal and external technical documents, writes technical memos/reports, patents, scientific articles.
• Represents department at project/CMC/Technology Transfer teams and works closely with other analytical, microbiology, device engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs, supply chain and Operations manufacturing sites to meet project timelines and objectives.
• Generates and maintains all required documentation including logbooks, lab notebooks, development/technology reports and manufacturing records to ensure products and processes are developed according to internal and regulatory guidelines.
• Maintains current knowledge level of formulation sciences and manufacture technologies by regularly reviewing technical literature, regulatory documentation and attending technical training courses to ensure that work performed is in accordance with the latest technical and regulatory information.

Preferred Qualifications:

• Strong laboratory skills and experience focused on topical ophthalmic, mucoadhesive, and nanostructured polymeric delivery systems is required.
• Expertise in product characterization techniques, such as rhelology, thermal analysis, dynamic light scattering, and infrared spectroscopy is required.
• Scientific problem solving, experimental design, and trouble shooting skills.
• Experience in laboratory documentation systems and demonstrated experience with technical report writing. Technical understanding and experience with products manufacturing, development, quality and analytics is preferred.
• Demonstrated excellence in writing, presentation, and overall communication.
• Must be able to operate as a functional area leader and utilize knowledge of pharmaceutical science, chemical engineering, literature and experience to guide decisions in complex situations.
• Knowledge of fundamental applications of statistics is preferred.
• Computational experience in Python, MATLAB, and R is a plus.

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Bachelor's Degree or equivalent education and typically 10 years of experience, Master's Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary.
• Possess thorough theoretical and practical understanding of own scientific discipline.

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.

This job is eligible to participate in our long-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.