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 Senior Scientist I to join a dynamic team of scientists responsible for all aspects of CMC analytical development required to move biologic candidates from discovery into and through clinical studies.
In this lab-based role, you will utilize your knowledge of protein chemistry and expertise in chromatography and capillary electrophoresis to contribute to development of AbbVie’s growing pipeline of clinical stage biotherapeutics, which include novel bispecific constructs, antibody-drug conjugates, and monoclonal antibodies. You will conduct experiments to characterize and investigate attributes of biologic drug candidates to provide product and process understanding, as well as develop innovative analytical methods that provide deeper insights into protein biotherapeutics across the development spectrum from candidate liability screening to process development to clinical development.
Perform capillary electrophoresis, and chromatographic testing to characterize post-translational modifications, quantify product quality attributes, and support development of biotherapeutic molecules.
Independently develop capillary electrophoresis, and chromatographic methods to characterize biotherapeutic molecules and quantify their associated variants and impurities.
Develop and implement innovative approaches to solve difficult analytical challenges.
Develop, qualify/validate, and transfer fit-for-purpose QC release and stability methods.
Provide technical support for QC testing occurring at internal and external GMP laboratories.
Conduct studies, author reports, and provide data for CMC regulatory submissions (INDs/CTDs/BLAs).
Present work and results in team and group meetings.
Document laboratory work according to good documentation practices.
This position is an onsite, lab-based role. 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.
Ph.D. in Chemistry, Biochemistry, or related field. BS with 10+/MS with 8+ years relevant experience and strong industry track record of scientific accomplishment will also be considered.
Must possess a solid understanding of protein chemistry and biochemistry, particularly as it relates to biotherapeutic drug development.
Demonstrated proficiency in developing and performing capillary electrophoresis and chromatographic methods as they apply protein characterization and quantitation. Experience in performing liquid chromatography mass spectrometry on biomolecules is beneficial.
Experience with CMC analytical development of monoclonal antibodies or related biotherapeutic proteins is preferred.
Analytical method development, qualification, and validation expertise is desirable.
Proven record of technical/scientific initiative, achievement, and innovation.
Ability to independently conceive, develop, execute, and implement novel/advanced scientific techniques.
Ability to create and maintain accurate and complete records, adhere to laboratory SOPs, and exhibit attention to detail.
Must have strong communication skills, including verbal, written, and scientific data presentation. Ability to author technical reports and presentations.
Must be able to work in a dynamic, fast-paced, collaborative environment and manage multiple concurrent assignments with high independence.
*Position can be hired as a Scientist II or Senior Scientist I based on the candidate's level of education and years of experience.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced
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.