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Senior Scientist I, Pharmaceutical Development, CMC Biologics, OED

Company: AbbVie
Location: Redwood City
Posted on: June 16, 2019

Job Description:

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 AbbVie Biotherapeutics, AbbVie's oncology research site in Redwood City, CA. Senior Scientist I, Pharmaceutical Development, CMC Biologics We have an exciting opportunity available for a Senior Scientist I within the Pharmaceutical Development Group in the CMC Biologics department at AbbVie, Redwood City, CA. AbbVie at Redwood City is an R&D organization focused on development of innovative biologics in the field of Oncology. This position will support CMC drug product development for oncology pipeline that include mAbs, ADCs, and novel bispecific antibody formats, through clinical proof-of-concept. Key responsibilities:

  • Develop preclinical and clinical formulations, including liquid and lyophilized dosage forms, and related drug product manufacturing processes
  • Transfer drug product manufacturing process to internal and external fill-finish facilities and provide on-site support as needed
  • Responsible for stability testing of representative lots and clinical in-use studies to guide dose solution administration
  • Generate high quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations and regulatory documents
  • Actively participate in drug product development teams and contribute to the planning and execution of product development studies including formulation and drug product process development, based on project goals and timelines
  • Actively interact with CMC members and other AbbVie stake holders to enable successful development of AbbVie drug products
  • Drive innovation by investigating and developing novel experimental approaches and/or technologies in the field of drug product development, and raise visibility within the scientific community through external presentations and publications EDUCATION and/or EXPERIENCE
    • Ph.D in pharmaceutical sciences, chemical engineering, analytical sciences or equivalent field with 0-3 years of experience or BS/MS degree with 8-10 years of relevant experience in the biotechnology or pharmaceutical industry.
    • A strong technical background encompassing protein chemistry, analytical development, and formulation development is required
    • Candidates must have hands-on expertise in analytical techniques used for protein characterization and stability testing
    • Prior experience in development of protein product formulations and lyophilization expertise is highly desirable
    • Demonstrated experience in driving innovation is a strong plus
    • Prior experience with aseptic processing, and drug product manufacture processes transfer is preferred
    • Excellent communication and written skills required At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.

Keywords: AbbVie, San Francisco , Senior Scientist I, Pharmaceutical Development, CMC Biologics, OED, Healthcare , Redwood City, California

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