Allergan Aesthetics, an AbbVie Company · 7 hours ago
Quality Control Senior Scientist I – Biologics Analytical Research & Development
South San Francisco, CA, USA
Full-time
Onsite
Senior Level, Lead/Staff
$94K/yr - $178K/yr
8+ years expAbbVie is a global biopharmaceutical company focused on innovative medicines and solutions. The Quality Control team is seeking a Senior Scientist I to manage GxP activities and collaborate on the development of biologic therapeutics for clinical studies.
BeautyWellnessManufacturingPharmaceutical
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
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)
Short-term incentive programs
Company
Allergan Aesthetics, an AbbVie Company
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.
1001-5000 employees
H1B Sponsorship
Allergan Aesthetics, an AbbVie Company 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
2024 (1)
2023 (1)
2022 (16)
2021 (14)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Nicole Mowad-Nassar
Senior Vice President, AbbVie and President, Global Allergan Aesthetics
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