The analytical development group for new biological entities (NBEs) develops analytical control strategies for antibody drug conjugates (ADC) and other biologics using state of the art analytical technologies.
We are looking for a highly motivated person who supports analytical development and routine testing of NBEs. The candidate will identify, investigate and implement novel experimental approaches to answer scientific questions to develop and optimize NBE drug substance process and drug product formulations. Working closely with analytical, process chemistry and formulation scientists, the candidate will develop productive collaborations and communications with scientific teams.
- Analytical characterization and assessment of process/formulation development samples and clinical trial supplies (e.g. GMP compliant stability and release testing).
- Execute and design experiments for method development and validation studies.
- Documents experimental data appropriately in laboratory documentation system and technical memos; contributes to writing technical reports.
- Maintains laboratory equipment and optimize laboratory operations for efficient use of time and resources.
- Lead troubleshooting of equipment and experimental problems.
- Brainstorm ideas for continuous improvement activities and leads initiative.
- Responsible for compliance with all applicable AbbVie policies and procedures.
- Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
- BS (5+ years) or MS (2+ years) in scientific discipline (e.g., Chemistry, Biochemistry, or Biology) with previous laboratory experience.
- Experience in analytical methodology, such as chromatography, KF, UV and compendial methods. Experience in bioanalytical techniques preferred (IEX, HIC, SEC, CGE, icIEF, particle imaging, ELISA).
- Experienced in laboratory systems (LIMS, CDS, ELN) preferred.
- Experience in Microsoft Office (Excel, Power Point, and Word) required.
- Analytical method validation knowledge and method development experience is preferred
Key AbbVie Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of teams to enable higher performance.
- Learns fast, grasps the "essence" and can change course quickly where indicated.
- 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.
Level and compensation will be commensurate with experience.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced