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
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.
Knowledge and hands-on experience with document management in the biopharmaceutical industry, including GxP electronic document management systems, is a plus.
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.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
We offer a comprehensive package of benefits including paid time off (vacation,
Benefits
Paid time offFlexible schedule
Additional Information
AbbVie's Biologics CMC Analytical Research and Development Group in South San Francisco is seeking an experienced and highly motivated Senior Scientist I to join our Quality Control team focused on early stage (first in human through Ph 2 clinical) development. The Quality Control team is responsible for a wide range of Quality Control GxP activities, including change management, document management, coordination of outsourced release and stability testing, shelf-life evaluation, preparation of Certificates of Analysis and coordination of the exception/quality event process. In this role, you will represent the QC function on one or more program teams, with responsibility for authoring quality documents and regulatory submission sections. You will collaborate with Technical and Quality SMEs to achieve QC deliverables for release of GMP drug substance and drug product batches to enable clinical supply, as well as manage shelf-life assignment for clinical batches. Additionally, you will create and/or review change records and quality event records in support of GxP activities.
Abbvie · South San Francisco, CA