Senior Scientist, Protein Analytics I/II

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description:

AbbVie is searching for a highly motivated individual to fill a Senior Scientist II position in the Protein Analytics Department at AbbVie Bioresearch Center in Worcester MA. The Protein Analytics Department is responsible for qualification and execution of analytical methods and characterization studies to provide product and process understanding as well as analytical CMC management for development of AbbVie biopharmaceutical pipeline from discovery through commercial stages.

The Analytical Characterization Group (ACG) within the Protein Analytics Department is seeking a highly experienced, motivated, and team-oriented individual for an important role supporting development and registration of AbbVie’s biologic pipeline of preclinical, clinical and commercial products. The successful candidate will be responsible for defining and executing analytical characterization strategies for biologics development. The successful candidate will lead the efforts in establishing protein characterization workflows and practices, especially in characterizing late-stage biotherapeutic products using liquid chromatography mass spectrometry (LC-MS), spectroscopy and various other biophysical assays. As a key member of ACG team, the successful candidate will interact effectively and transparently with team members and group leaders in the areas of Protein Analytics, Process Sciences, Manufacturing Sciences, Quality Control, Quality Assurance and CMC Project Management.  

Key Responsibilities:

• Lead the extended characterization strategy for ACG by working with a group of scientists to meet the demands of biologic portfolio development
• Independently lead, perform, and review LC-MS analyses (e.g., intact, reduced, sub-unit, peptide mapping, and disulfide bond mapping) of AbbVie’s biologics to provide sequence verification, post-translational modification profiles, sequence variant levels, and disulfide bond profiles
• Design, execute and review experiments for method development and/or investigations
• Collaborate cross-department to come up with the most effective approach to meet the demands of biologic development
• Drive identification, evaluation and implementation of new technologies
• Represent analytical function in the CMC program team; participate and lead the development of analytical control strategy for biologic programs
• Author and review filing documents and regulatory responses
• Contribute to the operation strategy development in Protein Analytics; foster close collaboration within the department and across functions for effective execution of department goals
• Develop a culture of continuous learning and growth in the group and create development opportunities for members of the group

Qualifications

Qualifications:

• BS, MS or PhD degree in chemistry, biology, biochemistry or related technical discipline with 10+ (BS), 8+ (MS) or 2+(PhD) years of relevant experience in academic or biotech/pharmaceutical industry setting or equivalent
• Minimum of 8 years of biopharmaceutical analytical experience with recombinant biologic modalities and exposure to all stages of biologics drug development
• Extensive hands-on experience with chromatography, electrophoresis, mass spectrometry and other analytical techniques
• Hands-on working experience in IND, IMPD and BLA authoring, review, submission, and regulatory response
• Knowledge of CMC analytical and regulatory requirements, including establishment of CQA assessment, analytical comparability and structure-function relationship reports
• Demonstrated track record of leading analytical method development, qualification and transfer activities of biophysical and biochemical methods of products and intermediates
• Ability to work effectively cross-functionally in anticipating and responding to overall program development needs
• Demonstrated record of independent thought, creativity and scientific accomplishment
• Self-motivated with the ability to act with urgency and passion

• Ability to make thoughtful, integrated, timely and meaningful recommendations and/or decision and take corresponding actions
• Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making
• Resourceful, enthusiastic and results-oriented

Key Leadership Competencies:

• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
• Delivers business results while also positioning AbbVie for long-term success
• Raises the bar and is never satisfied with the status quo
• Creates a learning environment, open to suggestions and experimentation for improvement
• Embraces the ideas of others, nurtures innovation and manages innovation to reality 

 

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.