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 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 AbbVie’s 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.
Key responsibilities Include:
Independently develop and apply cutting-edge mass spectrometry and other state of the art techniques to characterize biotherapeutic proteins and their associated variants and impurities.
Routinely maintain, calibrate, and operate Orbitrap and Q-TOF 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
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.
Qualifications:
Senior Scientist I: PhD in Chemistry, Biochemistry, Analytical Chemistry or related field. Candidates with MS (8+ years experience) or BS (10+ years experience) and proven track record of technical achievement and innovation will also be considered.
Must possess a solid understanding of protein chemistry and biochemistry, particularly as related to biotherapeutic protein drug development.
Demonstrated proficiency in developing and performing mass spectrometry and HPLC as they apply to protein characterization and quantification
Experience with CMC analytical development of monoclonal antibodies and biotherapeutic proteins is desired.
Expertise in the development of LCMS methods (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.
High degree of proficiency with relevant data analysis and quantitation software including Byos/Byonic, Skyline, Proteome Discoverer, Biopharma Finder, Protein Deconvolution, Empower, Xcalibur, MaxQuant, Chromeleon, SimGlycan or others is highly desirable.
Profound familiarity with interpretation and verification of mass spectra and results.
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.
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.
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.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.