AbbVie Scientist I at AbbVie designs, develops, and optimizes analytical methods to characterize biopharmaceutical products. The role involves troubleshooting, interpreting results, and ensuring compliance with corporate and regulatory standards.
Responsibilities
Independently design, develop, and optimize robust analytical methods using separations-based techniques (HPLC, icIEF, CE-SDS) to characterize biopharmaceutical products
Implement and innovate new experimental protocols/techniques.
Understand the goal and maintain a high proficiency in his/her projects as well as the overall program.
Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments.
Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner.
Perform routine and complex tasks competently and independently and generate reliable and consistent results.
Troubleshoot complex analytical issues and implement innovative solutions to improve method performance and efficiency.
Impact projects mostly through lab and/or pilot plant based activities.
Responsible for compliance with all applicable Corporate and Divisional policies and procedures.
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.
Bachelor’s Degree or equivalent education with typically 5 years of experience, or Master’s Degree or equivalent education with typically two years of experience.
Theoretical and practical knowledge to carry out the job functions.
Qualification
Required
Bachelor’s Degree or equivalent with 5 years experience, or Master’s Degree with 2 years experience
Theoretical and practical knowledge to carry out job functions
Preferred
Strong understanding of protein biochemistry and analytical method development principles.
Experience in developing and optimizing methods for charge variant analysis, including both icIEF and CEX techniques, with the ability to transfer these methods to a QC environment.
Proficiency in operating and troubleshooting analytical instrumentation (e.g., Agilent, Waters HPLC systems, Maurice, PA800 systems).
Experience with the qualification and validation of analytical methods in accordance with ICH, FDA, and USP guidelines, ensuring methods are suitable for late-phase development and regulatory submissions.
Experience using automation to standardize high-throughput workflows.
Familiarity with statistical tools for data analysis, Empower and regulatory guidelines.
Experience collaborating with the process development, quality control, and regulatory affairs teams to align analytical strategies with project timelines and goals.
Capable of providing technical guidance and mentorship to junior scientists and laboratory staff.
