Principal Research Scientist I, Biologics Process Analytics

Principal Research Scientist 1

The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as bi-specifics and novel modalities, to human clinical studies and eventual licensure.

AbbVie's Biologics CMC Analytical Research and Development Group in South San Francisco has an exciting opportunity for a Principal Research Scientist 1 to join a new team responsible for process analytics. The Process Analytics team's mission is to provide enhanced understanding of cell line, upstream, and downstream processes, and to streamline process development decisions and timelines through application of data-rich, high-throughput, rapid-turnaround analytics, and automation.

In this role, you will report to the Process Analytics team lead and be responsible for analytical testing and evaluation of process intermediates to enable cell line, cell culture, and purification development. Additionally, you will be responsible for conceiving, developing, and implementing innovative, fit-for-purpose in-process methods that advance analytical capabilities to enable cell line and process development.

Responsibilities include:

• 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 diverse methods.
• 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.
• Supervise 0-2 direct reports.
• This position is an onsite, lab-based role.
• To be successful, candidates must enjoy and thrive in a highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.

Qualifications:

• Ph.D. in analytical chemistry, chemistry, chemical biology, biochemistry, medicinal chemistry, or related field with a minimum of 6 years of relevant industry experience. MS and BS candidates with a minimum of 14 years (MS) or 16 years (BS) of relevant industry experience and strong record of technical achievement and innovation will also be considered.
• Understanding and experience with biopharmaceutical and/or pharmaceutical pipelines is required.
• Has independently managed on-going deliverables and timelines for high-volume testing projects.
• Proven ability to develop and implement innovative solutions to difficult technical challenges, including management of program or deliverables.
• Direct experience with characterization of antibodies, multi-specific/domain proteins, and ADCs.
• Expertise with diverse analytical assays for protein characterization such as: mass spectrometry (intact mass, peptide mapping), chromatography (IEX, SEC), electrophoresis (CE-SDS, icIEF), and optical plate reader assays.
• Deep understanding of at least one of the following: ELISA, QPCR, cellular assays, and NGS.
• Demonstrated experience executing complex methods on integrated liquid handling automation systems (Agilent AssayMap Bravo, SPT Firefly, Hamilton).
• Experience with protein purification for preparative use and/or analytical characterization.
• Ability to pilot next-generation technologies for multiplex quantitation of proteins.
• Has championed efficient lab and end-user centric ELN/LIMS solutions for inventory, data capture, metadata capture, and efficient reporting.
• Previous supervision experience is a plus.
• 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.
• Demonstrated background of high-quality publications.
• Must have ability to work collaboratively with a high degree of productivity in a dynamic, fast-paced, cross-functional environment.

This is an onsite position at AbbVie's South SF, CA location. The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.