Senior Scientist II, Analytical Development & Quality Control, CMC Biologics, OED

Employer
AbbVie
Location
Redwood City, CA, US
Posted
Jun 05, 2019
Ref
1808356
Required Education
Bachelors Degree
Position Type
Full time
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica®, Venclexta™, and Empliciti™ and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.

AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. AbbVie is also expanding their expertise through partnering with companies leading the way in emerging biologic technologies including oncolytic virus' and CAR-T cells.

POSITION DESCRIPTION

We have an exciting opportunity for a Senior Scientist to join the Protein Analytical Chemistry Group (within CMC Development) at the AbbVie location in Redwood City, CA. AbbVie Redwood City is an R&D organization focused on development of innovative biologics in the field of Oncology. In this role, you will utilize your knowledge of analytical protein chemistry and expertise in chromatography and capillary electrophoresis to contribute to CMC development of AbbVie's growing pipeline of clinical stage oncology biotherapeutics, which include novel bispecific constructs, antibody-drug conjugates, and monoclonal antibodies.

Key Responsibilities Include:

  • Independently develop and apply state of the art capillary electrophoresis and HPLC methods to characterize biotherapeutic proteins and their associated variants and impurities.
  • Identify post-translational modifications and characterize structure-activity relationships of products under development.
  • Develop innovative approaches to solve difficult analytical challenges.
  • Represent the Protein Analytical Chemistry Group as a subject matter expert on cross functional project teams.
  • Develop, qualify/validate, and transfer fit-for-purpose QC release and stability methods.
  • Provide technical support and oversight for QC testing occurring at internal and external GMP laboratories.
  • Plan and author characterization, comparability, and quality sections of regulatory submissions (INDs/CTDs).
  • Engage and influence the broader scientific community through publications and poster and oral presentations at industry conferences.

  • Bachelors, Masters, or PhD in Chemistry, Biochemistry, or related field with 10-12+ years (BS), 8-10+ years (MS), or 0-4+ years (PhD) of relevant experience. Position may be a lower/higher level based on degree and total years of relevant experience in industry and academia.
  • Must possess a solid understanding of protein chemistry and biochemistry, particularly as related to biotherapeutic protein drug development.
  • Experience representing analytical development function on cross-functional project teams.
  • Experience planning and coordinating analytical development projects involving multiple contributors and stakeholders is required.
  • Demonstrated proficiency in developing and performing capillary electrophoresis and HPLC methods as they apply to protein characterization.
  • Experience with CMC analytical development of monoclonal antibodies or related biotherapeutic proteins is required.
  • Proven record of advanced technical/scientific achievement and innovation.
  • Quality control and/or GMP experience is beneficial.
  • 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.