Scientist I/II, Pharmaceutical Development

Employer
AbbVie
Location
Redwood City, CA, US
Posted
Sep 13, 2018
Ref
1806675
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. This position will be based at Stemcentrx, AbbVie's South San Francisco, CA location.

Description

We currently have an opportunity available for a Scientist I/II within the Pharmaceutical Development Group in the CMC Biologics department at AbbVie, Redwood City, CA. This position will support formulation development stability studies and coordinate activities related to the GMP stability program for our early oncology pipeline.

Key responsibilities:
  • Conduct development stability testing for FIH programs. May support other formulation studies as needed
  • Coordinate review of internal and third party documents for seamless execution of AbbVie outsourced stability programs
  • Perform stability trend analysis for retest date assignment. Author stability reports and/or other stability testing documents as needed
  • Responsible for providing stability data for regulatory filings
  • Represent function in CMC team meetings
  • Organization and archival of QC stability documents


Education and/or Experience
  • BS or MS in Chemistry/Biochemistry/Pharmaceutical Sciences or related field with 7+ years (BS) or 4+ years (MS) of job related experience in the biotechnology and / or pharmaceutical industry.
  • Prior experience in drug product formulation development, conducting stability studies, and management of GMP stability programs required.
  • Strong technical skills to perform stability testing and trend analysis for biologics required. Experience using statistical tools such as JMP highly preferred.
  • Demonstrated project management skills to coordinate activities with local and global teams highly desirable.
  • Knowledge of relevant US/EU regulatory requirements for ensuring a compliant GMP stability program.
  • Excellent communication and written skills.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled