Job Description

AbbVie is searching for a highly motivated individual to fill a Principal Research Scientist position in the Advanced Characterization Group (ACG) within the Analytical Development (AD) department at AbbVie Bioresearch Center in Worcester MA to develop a comprehensive analytical characterization strategy for mAbs ADCs bi-specifics fusion proteins AAVs etc. This position calls for a strategic thinker with a robust technical background in analytics coupled with the ability to lead cross-functional teams manage intricate projects and communicate effectively with stakeholders. The AD group is responsible for qualification and execution of analytical methods and characterization studies to provide product and process understanding of AbbVies biopharmaceutical pipeline from discovery through commercial stages. The successful candidate will be responsible for defining and executing analytical characterization strategies for biologics development leading 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 this role the individual will directly lead research and project activities and support the professional development of a group of scientists by effectively mentoring guiding and/or supervising scientific personnel. The individual will independently conceive execute and communicate novel multi-disciplinary research and development strategies that achieve project and area goals serving as a lead scientist on their own projects while contributing scientific insights across multiple others. As a key member of the ACG team the successful candidate will interact effectively and transparently with team members and group leaders across Analytical Development Process Sciences Manufacturing Sciences Quality Control Quality Assurance and CMC Project Management and will act as lab manager overseeing the mass spectrometry and biophysical characterization lab at the Worcester site.    

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 AbbVies 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 develop the most effective approach to meet the demands of biologic development.
• Drive identification evaluation and implementation of new technologies.
• Represent the analytical function in the CMC program team; participate in 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 Analytical Development; 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.
• Effectively function as a principal investigator generating original technical ideas and research or development strategies.
• Demonstrate creative out-of-the-box thinking to solve difficult problems and champion new technologies to achieve project goals.
• Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
• Primary author of publications presentations regulatory documents and/or primary inventor of patents.
• Present at leading scientific conferences.
• Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.

Qualifications :

• BS or equivalent education and extensive typically 14 years of experience; MS or equivalent education with typically 12 years of experience; PhD with typically 6 years of experience in analytical chemistry biochemistry or a related scientific discipline.
• Demonstrated expertise in LC-MS-based characterization of biologics including intact mass analysis peptide mapping post-translational modification profiling sequence variant analysis and disulfide bond mapping with extensive hands-on experience in chromatography electrophoresis and other analytical techniques.
• Demonstrated track record of leading analytical method development qualification and transfer activities of biophysical and biochemical methods for products and intermediates in an analytical development or biopharmaceutical environment.
• Hands-on experience in IND IMPD and BLA authoring review submission and regulatory response with strong knowledge of CMC analytical and regulatory requirements including CQA assessment analytical comparability and structure-function relationship reports.
• Experience representing the analytical function on CMC program teams contributing to analytical control strategy development and working effectively cross-functionally in anticipating and responding to overall program development needs.
• Demonstrated ability to function as a principal investigator generating original technical ideas and research or development strategies with a proven record of independent thought creativity and scientific accomplishment.
• Experienced and demonstrated success as a primary author of publications presentations patents and regulatory documents with strong scientific communication skills including presenting at leading scientific conferences.
• Proven ability to mentor and develop scientific teams fostering a culture of continuous learning and growth.
• Self-motivated with the ability to act with urgency and passion; resourceful enthusiastic and results-oriented.
• Ability to make thoughtful integrated timely and meaningful recommendations and/or decisions and take corresponding actions while working collaboratively by incorporating diverse perspectives and appropriately managing relationships to strengthen decision-making.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• 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 long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

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. 

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No

Employment Type :

Full-time

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