Scientist II, Protein Analytical Chemistry, CMC

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

AbbVie has expanded 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.

We have an exciting opportunity available for a Scientist II within the Protein Analytical Chemistry department in the CMC Biologics organization at AbbVie. This position will support CMC analytical development for an oncology pipeline that include mAbs, ADCs, and novel bispecific antibody formats, through clinical proof-of-concept.

POSITION DESCRIPTION

The Scientist II position is in the Protein Analytical Chemistry department within the CMC Biologics organization in Redwood City, CA. The Protein Analytical Chemistry department is 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 mass spectrometry, chromatography, and capillary electrophoresis to contribute to development of AbbVie's growing pipeline of clinical stage oncology 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.

Key Responsibilities Include:

• Perform mass spectrometry, capillary electrophoresis, and HPLC testing to characterize post-translational modifications, quantify product quality attributes, and support development of therapeutic antibodies, antibody variants, and antibody drug conjugates (ADCs).
• Contribute to the development of state of the art mass spectrometry, capillary electrophoresis, and HPLC methods to characterize biotherapeutic proteins and quantify their associated variants and impurities.
• Develop innovative approaches to solve difficult analytical challenges.
• Develop, 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).
• Present work and results in team and group meetings.

Qualifications

• BS in Chemistry, Biochemistry or related field with 7+ years of experience in the biopharmaceutical industry or MS with 5+ years experience.
• Must possess a solid understanding of protein chemistry and biochemistry, particularly as it relates to biotherapeutic protein drug development.
• Demonstrated proficiency in developing and performing mass spectrometry, capillary electrophoresis and HPLC methods as they apply to protein characterization and quantitation
• Experience with CMC analytical development of monoclonal antibodies or related biotherapeutic proteins.
• HPLC / LCMS method development, qualification, and validation expertise is desirable.
• Proven record of technical/scientific achievement and innovation.
• Ability to learn new techniques, create and maintain accurate and complete records, adhere to laboratory SOPs, and exhibit attention to detail.
• Must have strong written and verbal communications skills.
• Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent assignments with a high degree of independence.

Significant Work Activities
N/A
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
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.