Senior Scientist I, Analytical Development (separations)

Group:

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.

Position Overview:

We have an exciting opportunity for a Senior Scientist to join the Advanced Instrumentation and Mass Spectrometry (AIMS) Group (within the Biologics CMC Analytical Research and Development organization) at the AbbVie location in South San Francisco CA.  In this role you will utilize your knowledge of analytical protein chemistry and expertise in a variety of state of the art mass spectrometry techniques as well as electrophoretic and high performance liquid chromatographic methods to enable CMC development of AbbVies growing pipeline of clinical stage complex biotherapeutics which include novel bispecific constructs antibody-drug conjugates and monoclonal antibodies. You will be responsible for conceiving developing and applying innovative molecular characterization methodologies. You will collaborate with colleagues in pharmaceutical development process development and the broader analytical development group and perform testing and provide analytical results that enhance molecule understanding and drive development decisions. 

Responsibilities: 

• Independently develop and apply cutting-edge state of the art techniques including mass spectrometry to characterize biotherapeutic proteins and their associated variants and impurities.
• Routinely maintain calibrate and operate ultrahigh performance liquid chromatography systems as well as Orbitrap mass spectrometers and acquire purposefully considered and carefully implemented experimental results.
• Adapt innovative new technologies to conventional methods to elucidate peak identities and more fully characterize drug substances and products.
• Automate routine analyses to provide consistent and reliable MS characterization and relative quantitation (e.g. MAM)
• Detect identify and quantity protein variants and product quality attributes using a variety of separation techniques and multidimensional chromatography/fraction collection.
• Employ chromatographic and/or electrophoretic methods to isolate molecule variants for further characterization
• Identify post-translational modifications and characterize structure-activity relationships of products under development.
• Develop innovative approaches to solve difficult analytical challenges.
• Collaborate with other members of the analytical team including Bioassay Process Analytics and Separations to characterize drug substance drug product and impurities
• May author molecular characterization comparability and/or quality sections of regulatory submissions (INDs/CTDs)..
• Serve as an analytical subject matter expert on cross functional teams.
• Engage and influence the broader scientific community through publications and poster and oral presentations at industry conferences.

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. Travel up to 5%.

Qualifications :

• Senior Scientist I:  MS (8 years industry experience) or BS (10 years industry experience) or PhD in Chemistry Biochemistry Analytical Chemistry or related field may also be considered.
• Proven track record of technical achievement in a CMC roll.
• Must possess a solid understanding of protein chemistry and biochemistry particularly as related to biotherapeutic protein drug development.
• Demonstrated proficiency in developing and performing HPLC and mass spectrometry as they apply to protein characterization and quantification
• Extensive experience with CMC analytical development of monoclonal antibodies and biotherapeutic proteins is desired.
• Familiarity with the development of LCMS methods (e.g. Peptide Mapping Native Top-Down MAM PRM DIA CDMS).
• Proven record of advanced technical/scientific achievement and innovation.
• Knowledge and experience with common modalities of protein and peptide analyte separation including reverse phase HILIC HIC SEC affinity capture CEX and CZE hyphenated mass spec techniques.
• Experience with peak identity elucidation though fractionation orthogonal chromatographic separation and 2D liquid chromatography.
• Proficiency with enrichment strategies to differentiate analytes from matrix through selective enhancement/depletion.
• Familiarity with interpretation and verification of mass spectra and results and use of relevant data analysis and quantitation software (e.g. Byos/Byonic Skyline Proteome Discoverer Biopharma Finder etc.)
• Must have strong written and verbal communications skills.
• Must be capable of working in a fast-paced collaborative environment and managing multiple concurrent projects with a high degree of independence.

Additional Information :

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

• 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. Travel up to 5%.
• 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. 

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

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. 

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