Principal Research Scientist I, Process Analytics Lead - Analytical R&D

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.

We have an exciting opportunity for an experienced analytical scientist to build and lead a team of 3-4 analytical scientists responsible for process analytics. The Process Analytics team’s mission will be 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 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.  You will collaborate directly with Molecule Leads and scientists from Process Development and Analytical Development to enable process understanding and drive process development decisions through all phases of CMC development.   

This position is an onsite role in a lab-based function.  To be successful candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.

Responsibilities include:

• Lead a Process Analytics team of 3-4 analytical scientists, setting strategy and goals, coordinating day-to-day activities, and providing training and mentorship.
• Conceive and develop innovative, data rich, high-throughput, and automated in-process analytical methods to enable and enhance process understanding and process development efficiency
• Lead and perform analytical testing and evaluation of process intermediates
• Collaborate closely with the Process Development Group to forecast testing activities and align on priorities and deliverables
• Employ multi-attribute methods, LCMS peptide mapping, U/HPLC, CE, ELISA and other analytical methodologies for analysis of process intermediates
• Act as a close partner to Process Scientists in selecting cell lines and delivering upstream and downstream processes
• 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 analytical subject matter experts 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 a subject matter expert for in-process analytics on cross-functional teams
• Document laboratory work according to good documentation practices

Requirements:

• Degree in chemistry, biochemistry, or related field with a minimum of 6 years (Ph.D.), 12 years (MS) or 14 years (BS) of relevant experience
• Expertise and experience in CMC Analytical Development of protein therapeutics
• Experience in application of analytical methods to process development and general understanding of process steps employed in manufacture of recombinant protein therapeutics is highly desired
• Solid understanding of therapeutic protein quality attributes, especially in the context of influence of cell line and manufacturing process on such attributes
• Proficiency with LCMS peptide mapping for PTM analysis of antibodies, bispecifics and similar protein therapeutics
• Biologics analytical method development expertise, including but not limited to Mass Spectrometry, HPLC, UPLC, CE, ELISA, Octet, and other binding assay formats
• Experience with multi-attribute methods (MAM) and automation pertaining to liquid handling, sample preparation, and testing is a plus
• Demonstrated successful history of supervisory experience
• Demonstrated ability to develop innovative solutions to difficult technical challenges and champion new technologies to achieve project goals
• Must have strong 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, regulatory documents, and presentations
• Must have ability to work collaboratively with a high degree of productivity in a dynamic, fast-paced, cross-functional environment

 

*Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

 

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