Advanced Clinical
Overview
Senior Scientist role at Advanced Clinical. We’re looking for a Senior Scientist to support analytical activities for late-stage biologics programs. This role involves collaboration with external partners and internal teams to ensure robust analytical development, validation, and regulatory support. The ideal candidate brings strong expertise in potency assays, especially cell-based assays, along with a solid foundation in biologics analytical methods. Responsibilities
Lead and support analytical activities for late-stage biologic candidates. Collaborate with CROs and CDMOs to coordinate analytical testing and oversee method transfers. Author and review analytical methods, protocols, and validation documentation. Evaluate analytical method validations and ensure scientific and regulatory integrity. Partner with regulatory teams to prepare and review analytical sections of submissions and respond to agency information requests. Provide subject matter expertise in potency assays, particularly Cell-Based Assays. Basic Qualifications
Bachelor’s degree in Biochemistry, Molecular Biology, or a related scientific field with 8+ years of industry experience. Master’s degree in Biochemistry, Molecular Biology, or a related field with 6+ years of experience. Ph.D. in Biochemistry, Molecular Biology, or a related field with 4+ years of experience. Preferred Qualifications
Deep expertise in potency assays for biologics, particularly Cell-Based Assays. Working knowledge of additional analytical techniques for biologics. Hands-on experience with CRO/CDMO collaboration, method transfers, and method development. Proven ability to manage multiple studies across different laboratories. Familiarity with method validation principles and regulatory expectations. Experience supporting U.S. and international regulatory filings (e.g., BLA). Strong understanding of monoclonal antibodies (mAbs) and other biologics, their critical quality attributes, and corresponding analytical tests. Excellent communication skills with the ability to explain complex analytical concepts to non-experts.
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Senior Scientist role at Advanced Clinical. We’re looking for a Senior Scientist to support analytical activities for late-stage biologics programs. This role involves collaboration with external partners and internal teams to ensure robust analytical development, validation, and regulatory support. The ideal candidate brings strong expertise in potency assays, especially cell-based assays, along with a solid foundation in biologics analytical methods. Responsibilities
Lead and support analytical activities for late-stage biologic candidates. Collaborate with CROs and CDMOs to coordinate analytical testing and oversee method transfers. Author and review analytical methods, protocols, and validation documentation. Evaluate analytical method validations and ensure scientific and regulatory integrity. Partner with regulatory teams to prepare and review analytical sections of submissions and respond to agency information requests. Provide subject matter expertise in potency assays, particularly Cell-Based Assays. Basic Qualifications
Bachelor’s degree in Biochemistry, Molecular Biology, or a related scientific field with 8+ years of industry experience. Master’s degree in Biochemistry, Molecular Biology, or a related field with 6+ years of experience. Ph.D. in Biochemistry, Molecular Biology, or a related field with 4+ years of experience. Preferred Qualifications
Deep expertise in potency assays for biologics, particularly Cell-Based Assays. Working knowledge of additional analytical techniques for biologics. Hands-on experience with CRO/CDMO collaboration, method transfers, and method development. Proven ability to manage multiple studies across different laboratories. Familiarity with method validation principles and regulatory expectations. Experience supporting U.S. and international regulatory filings (e.g., BLA). Strong understanding of monoclonal antibodies (mAbs) and other biologics, their critical quality attributes, and corresponding analytical tests. Excellent communication skills with the ability to explain complex analytical concepts to non-experts.
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