AbbVie is searching for an experienced and highly motivated individual to fill a Sr. 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 as well as life-cycle management.
The Department of Protein Analytics 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 part of the New Modality Group within Protein Analytics, leading the team efforts on separation based analytical method development, qualification and transfer for biological molecules, with special focus on non-monoclonal antibody biologics programs, e.g. Fc fusion proteins and other recombinant proteins. As a key member of the New Modality group, the successful candidate will interact effectively and transparently with team members in the areas of Protein Analytics, Bioprocess Development, CMC Project Management, Quality Control and Quality Assurance and contribute to the continuous improvement and innovation within S&T Biologics.
- Manage a small group within the New Modality Group.
- Lead the development and execution of a quality-driven strategy in applying separation based analytical assays in process development and process characterization support.
- Work collaboratively within the New Modality Group to enable development of non-platform analytical methods for non-mAb biologics development.
- Drive innovation and implement new technologies to continuously build the capabilities of the NMG group and PA department.
- Lead and participate in development and qualification of separation based analytical methods for purity and heterogeneity for QC release and stability.
- Lead and participate in PA method protocol and technical report drafting and review.
- Contribute to the development and implementation of N-linked and complicated glycan profiling strategy and risk assessment for all pipeline projects.
- Address and solve technical problems independently.
- Author and review IND and BLA filing documents and regulatory responses.
- Assume responsibility of an analytical lead, represent analytical function in the cross-functional CMC program team; participate and lead the development of analytical control strategy for biologic programs.
- Contribute to the operation strategy development in Protein Analytics; foster close collaboration within the department and across functions for effective execution of department goals.
- PhD Degree with 2+ years or MS with 8+ years of experience within Biochemistry, Chemistry, Analytical Chemistry, Biophysics (or related discipline) in industry or academia.
- Experience with separation (HPLC, UPLC and electrophoresis) based analytical methods (SEC, CEX, HIC, icIEF, HILIC, CE-SDS, mCE) is required.
- Experience with N-glycan analysis (2-AB and HILIC, RapiFluor) and sialic acid analysis is desired.
- Experience with LC-MS analysis of biologics is a plus.
- Experience with CMC analytical development of monoclonal antibodies or related biotherapeutic proteins is desired.
- Understanding of CQA assessment, comparability study, and specification justification is a plus.
- Must have strong written and verbal communications skills.
- Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with a high degree of independence.
Significant Work Activities: N/A
Job Type: Experienced