Associate QC Tech Resources Scientist Full-time NEW

Quality Control Method Management

Supports method lifecycle management within Quality Control (QC). This position utilizes and applies scientific knowledge and techniques to perform and review assay characterization, optimization, transfer, validation, and investigation. As a subject matter expert (SME), the role provides guidance, technical advice, and supervision for release, stability, in-process testing, and assay development.

Essential duties and responsibilities include, but are not limited to, the following:

• Collaborate with Analytical Sciences (AS) to integrate methods into QC Commercial, evaluating and selecting suitable methods prior to process validation.
• Monitor and analyze daily method performance in the QC lab, coordinating with subject matter experts for problem resolution as needed.
• Liaise with Regulatory Sciences and External Manufacturing to manage timelines for method validation and transfers, communicating updates to management.
• Monitor method updates, performance, and quality metrics, ensuring consistent harmonization and performance evaluations across multiple sites.
• Coordinate post-transfer investigations and multi-site trending, escalating issues to management when necessary.
• Drive process improvements and support investigational analysis, performing and coordinating assay qualifications and transfers.
• Develop and draft new test procedures and assays, authoring technical documents like Analytical Development and Validation Reports.
• Participate in training programs for QC personnel, ensuring all activities align with project timelines and deliverables.

Education and experience:

• Assoc: Requires a BS/BA in Chemistry, Biochemistry, Biology or related field, or equivalent combination of education and experience.
• Int: Requires a BS/BA in Chemistry, Biochemistry, Biology or related field and 2+ years of experience or equivalent combination of education and experience.
• Sr: Requires a BS/BA in Chemistry, Biochemistry, Biology or related field and 5+ years of experience or equivalent combination of education and experience.