Scientist l, Analytical Development (Biologics)

Job Opportunities At AbbVie

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.

AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic products. Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from the selection of discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines.

The Analytical Development Early phase group within Biologics ARD is responsible for early development (through proof-of-concept) of programs. The team focuses on method development, optimization, and validation, as well as non-GxP and GxP testing of clinical supplies to meet analytical deliverables. In collaboration with cross-functional partners, the team supports formulation and process development studies. Key team deliverables include robust analytical methods, clinical supplies release testing and stability studies to establish clinical product dating, product control strategies informed by analytical data and method understanding, comprehensive data packages that drive product and process understanding, and regulatory submission content.

Key Responsibilities

• Demonstrate mastery of a broad range of experimental techniques and methods of data analysis.
• Design and execute method development and participate in method transfer activities.
• Act as a key technical contact for external parties and lead troubleshooting of equipment and experimental problems.
• Provide laboratory support for internal formulation and process development studies.
• Effectively organize and present scientific plans and data.
• Author technical documents (e.g. methods, protocols, reports), scientific publications, presentations, and regulatory documents.
• Brainstorm ideas for continuous improvement activities and lead/participate in initiatives.
• Ensure safety and GxP requirements are met when performing tasks as needed.
• Ensure timely and GxP compliant delivery of high quality precise data as needed.

Qualifications

• Bachelor's Degree (5+ years) or Master's Degree (2+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with previous laboratory experience.
• Practical experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis.
• Must possess a solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development.
• Demonstrated independent problem-solving ability in science and technical proficiency.
• Demonstrated ability to learn, understand, and master new experimental techniques.
• Ability to multitask and work within timelines.
• Demonstrated scientific writing skills and excellent verbal communication skills.

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.