Senior Scientist II, Protein Analytical Chemistry Expert
4 weeks ago
AbbVie is a leading biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. We are seeking a highly skilled Senior Scientist II to join our Biologics CMC Analytical Research and Development Group in South San Francisco.
This is an exciting opportunity to contribute to the development of AbbVie's growing pipeline of clinical stage oncology biotherapeutics. As a Senior Scientist II, you will utilize your expertise in protein chemistry and analytical techniques to characterize and investigate attributes of biologic drug candidates.
Key Responsibilities Include:
- Develop and implement state-of-the-art analytical methods to characterize biotherapeutic proteins and their associated variants and impurities.
- Characterize post-translational modifications and structure-activity relationships of products under development.
- Develop innovative approaches to solve complex analytical challenges.
- Represent the Biologics CMC Analytical Research and Development 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 presentations at industry conferences.
Qualifications:
- Bachelor's Degree or equivalent education and 12 years of experience, Master's Degree or equivalent education and 10 years of experience, PhD and 4 years of 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 analytical methods as they apply to protein characterization.
- Experience with CMC analytical development of monoclonal antibodies or related biotherapeutic proteins is preferred, but not 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.
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