AbbVie · 5 hours ago
Quality Control Senior Scientist I – Biologics Analytical Research & Development
South San Francisco, CA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions for serious health issues. They are seeking an experienced Senior Scientist I to join their Quality Control team, focusing on early stage development and responsible for a variety of GxP activities including quality document authoring and collaboration with technical experts.
BiotechnologyFinanceHealthcarePharmaceuticalVenture CapitalFinancial ServicesHealth CareMedical
Responsibilities
Represent the QC function on cross functional program teams
Collaborate with analytical leads to achieve release and stability program deliverables
Author quality documents and regulatory submissions to enable regulatory submissions and clinical supply
Perform data verification
Trending of stability trending using JMP or other statistical software to support retest dating
Prepare and review quality control documents, including certificates of analysis, method validation reports, reference standard qualification reports, release & stability protocols, and stability reports
Initiate and review change records in collaboration with Technical and Quality SMEs and stakeholders
Coordinate closely with document authors, owners, stakeholders and approvers in South San Francisco and other AbbVie sites to initiate and complete document workflows within target timelines
Ensure compliance with SOPs, standards, and requirements
Provide support during internal and external audits and inspections
Serve as a subject matter expert for GxP quality system document management activities including: document formatting, document processing in the electronic document management system, document categorization/numbering nomenclature, and approval
Qualification
Required
Bachelor's Degree or equivalent education with typically 10+ years of relevant experience, or Master's Degree or equivalent education with typically 8+ years of relevant experience
General understanding of analytical methods typically employed for release and stability testing of protein therapeutics (monoclonal antibodies and antibody drug conjugates)
Experience evaluating and trending GMP stability data for drug substance and drug product shelf life assignment
Proficient in data analysis tools (e.g. JMP) and LIMS systems
Experience authoring quality control related change records and exception reports
Solid understanding of test methods used for release and stability analysis of antibody based therapeutics as acquired through hands on lab experience
Strong knowledge of GxP compliance requirements
High attention to detail and proven critical thinking skills
Must have a proactive approach, take initiative, and independently follow through with responsibilities
Well-developed data and time organization/management skills
Effective interpersonal, collaboration and communication skills for facilitating collaborations with customers and stakeholders, including scientists, quality control staff, and quality assurance partners
Must have ability to maintain a high degree of productivity in a dynamic, fast-paced, cross-functional environment
Must be adaptable and flexible in the face of evolving priorities and timelines
Effective and timely communications on issues and solutions; both within the team and to the customers and colleagues outside the team
This position is an on-site role. To be successful, candidates must enjoy and thrive in an on-site, highly collaborative environment with daily face-to-face cross-functional interactions between scientists and colleagues
Preferred
Knowledge and hands-on experience with document management in the biopharmaceutical industry, including GxP electronic document management systems, is a plus
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-02-12
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2026-02-12
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