Senior Scientist I, Process Analytics Expert

2 weeks ago


South San Francisco, California, United States AbbVie Full time
Job Summary

We are seeking a highly skilled Senior Scientist I to join our Biologics CMC Development team at AbbVie in the Bay Area. The successful candidate will be responsible for providing enhanced understanding of cell line, upstream, and downstream processes through the application of data-rich, high-throughput, rapid-turnaround analytics and automation.

Key Responsibilities
  • Conceive and develop innovative, data-rich, high-throughput, and automated in-process analytical methods and workflows to enable and enhance process understanding and process development efficiency.
  • Perform analytical testing of process intermediates using LCMS peptide mapping, mass spectrometry, U/HPLC, capillary electrophoresis, ELISA, and automation.
  • Collaborate closely with Cell Line Development and Process Development scientists to plan and execute analytical testing for process development experiments.
  • Interpret and communicate in-process analytical results to cross-functional collaborators and stakeholders in a manner that informs cell line selection and process development decisions.
  • Collaborate and communicate effectively with Analytical Molecule Leads to provide data and results from in-process testing for consideration in the context of the overall Analytical Development/QC control strategy.
  • Engage with analytical subject matter experts (SME) to investigate in-process findings that warrant further interrogation with advanced extended characterization methodologies.
  • Work efficiently, collaboratively, and cross-functionally toward project timelines and goals.
  • Serve as an SME for in-process analytics on cross-functional teams.
  • Document laboratory work according to good documentation practices.
Requirements
  • Ph.D. in analytical chemistry, chemistry, biochemistry, or related field. MS and BS candidates with minimum of 8 years (MS) or 10 years (BS) of relevant industry experience and strong record of technical achievement and innovation will also be considered.
  • Expertise with at least one of the following technologies: MAM, LCMS peptide mapping, mass spectrometry, U/HPLC, capillary electrophoresis, ELISA, QPCR, and optical plate reader assays.
  • Demonstrated 'super-user' level experience developing complex methods, as listed above, on integrated liquid handling automation systems in collaboration with colleagues such as SME's and automation engineers.
  • Focus on sustained analytical throughput and data quality in a development or production environment including control strategies such as continuous improvement, control charting, and CAPA.
  • Has independently managed on-going deliverables and timelines for analytical testing projects.
  • Has championed efficient lab and end-user centric ELN/LIMS solutions for data capture, metadata capture, and reporting.
  • General understanding of CMC Analytical Development of protein therapeutics is desired.
  • Experience in application of analytical methods to characterize process development in multi-step biological workflows is a bonus.
  • Pluses includes background in DOE, statistical methods, and data visualization.
  • Proven ability to develop innovative solutions to difficult technical challenges to achieve project goals.
  • Must have effective communication skills, including verbal, written, and scientific data presentation.
  • Must be forward-thinking and able to lead and contribute to scientific/technical discussions.
  • Ability to independently learn, understand and execute novel/advanced scientific techniques.
  • Ability to author technical reports and presentations.
  • Must have ability to work collaboratively with a high degree of productivity in a dynamic, fast-paced, cross-functional environment.


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