AbbVie Analytical Research &Development (Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our scope includes AbbVie's diverse pipeline of innovative small molecule and therapeutic biologic medicines and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines. Careers in AbbVie Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies. We are looking for diverse candidates with strong scientific and leadership experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.
The analytical development group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other biologics by state of the art analytical technologies. We prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
We are looking for a highly motivated person who can lead the analytical development of new biologic candidates from FIH through registration. The candidate will be responsible executing activities required for analytical development. The candidate must be able to mentor junior staff with novel experimental approaches to answer scientific questions to develop and optimize NBE drug product formulations. Working closely with formulation and process development scientists, the Senior Scientist I will d evelop productive collaborations and communications with scientific teams.
Section I: Major Responsibilities
- Design, execute and assess experimental data for analytical characterization, formulation/process development samples and clinical trial supplies (e.g. GMP compliant stability and batch release testing).
- Support development of therapeutic proteins at various stages
- Author and/or review key regulatory documents, laboratory data, technical memos and reports.
- Support activities associated with formulation/process development design and characterization for new biologic compounds.
- Mentor small project team(s) in the execution and design experiments for method development and validation studies.
- Mentor junior staff in troubleshooting of equipment and experimental problems.
- Encourage ideas for continuous improvement activities and initiatives within work group.
- Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
- BS with 10+ years experience; MS with 8+ years; or PhD (0 + years) in Chemistry, Biochemistry, Pharmacy or Biology required. Previous work experience in a cGMP (i.e. QC or equivalent) pharmaceutical laboratory setting preferred.
- Previous supervisory experience of laboratory staff (2+ years).
- Experience in analytical methodology, such as chromatography, KF, UV and compendial methods and bioanalytical techniques preferred (WCX, HIC, SEC, CGE, icIEF, particle imaging, ELISA and LC-MS).
- Experienced in laboratory systems (LIMS, CDS, ELN) preferred.
- Statistical knowledge and experience is preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies.
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.
Associated topics: biochemistry, ceramic, chemistry, coating, formulation, glass, latex, material, material science, rubber