AbbVie is searching for a highly motivated individual to fill a Senior Scientist I/II position in the Analytical Development Department at AbbVie Bioresearch Center in Worcester MA. The Analytical Development Department is responsible for development, qualification and execution of analytical methods and characterization studies to provide product and process understanding for development of AbbVie biopharmaceutical pipeline from discovery through commercial stages.
Analytical Development is seeking a highly experienced, motivated and team-oriented individual for an important role supporting development of AbbVie’s biologic pipeline of preclinical and clinical products. The successful candidate will be a member of the Process Analytics team responsible for development and execution of various separation methods (HPLC, CE, icIEF, etc.) and other analytical methods (small scale purification, SoloVPE, etc.) to support the CMC development of AbbVie early phase products and processes throughout the drug development lifecycle.
Key Responsibilities:
- Independently develop and apply capillary electrophoresis, and HPLC methods separation as well as other analytical methods to enable biological process development
- Develop, qualify, and transfer fit-for-purpose in-process control methods to QC.
- Provide technical support to QC testing occurring at internal and external GMP testing laboratories.
- Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
- Publish research in peer-reviewed journals and present work at scientific conferences.
- Proactively seek out new information in the literature and incorporate this into individual project(s) as well as the overall program.
- Seize opportunities to pursue project relevant leads that are in line with the group’s strategy.
- Maintain a high level of productivity in the lab.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.
- May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.
- Represent analytical function in the CMC program team; represent the Analytical Development Group as a subject matter expert on cross functional teams. Lead the development of analytical control strategy for biologic programs
- Plan and author internal technical reports as well as relevant CMC sections of regulatory submissions (INDs/CTDs).
- Identify and lead analytical innovations to further scientific capability of the group.