Cedent
Associate Director/Director, Bioanalytic Development & Operations (Waltham, MA)
Cedent, Waltham, Massachusetts, United States, 02254
Responsibilities (Including, but not limited to):
Lead and oversee the development, validation and application of bioanalytical techniques (LC-MS, ELISA, MSD, PCR, cell-based assays) to support PK, PD, biomarker and immunogenicity objectives in non-clinical and clinical studies Serve as the departments subject matter expert and be a team resource for bioanalytical knowledge, strategy and application in drug development Leverage depth of knowledge and hands-on experience with bioanalytical techniques to advise on assay design, method validation design, and interpretation of method performance data. Coordinate and supervise studies conducted at CROs including generation of proposals and SOWs, data generation and analysis, and troubleshooting. Author and review bioanalytical reports or summary sections for preclinical/non-clinical/clinical reports, and regulatory documents for initiation of clinical studies (such as IND and CTA) and drug approvals (such as NDA and MAA) Prepare, track, and maintain all necessary regents and documentation associated with bioanalytical assays Oversee and coordinate collection, processing, storage, and reconciliation of clinical trial samples Manage, monitor and document sample transfer between clinical sites, central labs, and testing labs. Collaborate with discovery, non-clinical and clinical teams to generate reagents and develop assays to meet project timelines. Stay abreast of literature, government guidelines, and internal guidance as relates to the development and use of bioanalytical methods Requirements
Requires a BS in biological field and a minimum of 10 years' relevant biotechnology industry experience; or an MS degree with a minimum of 8 years' experience; or a PhD and a minimum of 5 years' of experience Experience with development and qualification of PK/PD and immunogenicity assays in ELISA, MSD and other formats in both human and animal matrices Deep scientific and technical experience with and understanding of therapeutic antibody non-clinical and clinical development Excellent time management skills and the ability to work with a sense of urgency in a highly collaborative team environment Strong oral and written communication including the ability to present information clearly and logically Ability to prioritize and manage multiple projects to meet critical deadlines Strong attention to detail and problem-solving skills Works effectively in a team environment Strong commitment to ethical standards Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) The salary range for this position is commensurate with experience
Lead and oversee the development, validation and application of bioanalytical techniques (LC-MS, ELISA, MSD, PCR, cell-based assays) to support PK, PD, biomarker and immunogenicity objectives in non-clinical and clinical studies Serve as the departments subject matter expert and be a team resource for bioanalytical knowledge, strategy and application in drug development Leverage depth of knowledge and hands-on experience with bioanalytical techniques to advise on assay design, method validation design, and interpretation of method performance data. Coordinate and supervise studies conducted at CROs including generation of proposals and SOWs, data generation and analysis, and troubleshooting. Author and review bioanalytical reports or summary sections for preclinical/non-clinical/clinical reports, and regulatory documents for initiation of clinical studies (such as IND and CTA) and drug approvals (such as NDA and MAA) Prepare, track, and maintain all necessary regents and documentation associated with bioanalytical assays Oversee and coordinate collection, processing, storage, and reconciliation of clinical trial samples Manage, monitor and document sample transfer between clinical sites, central labs, and testing labs. Collaborate with discovery, non-clinical and clinical teams to generate reagents and develop assays to meet project timelines. Stay abreast of literature, government guidelines, and internal guidance as relates to the development and use of bioanalytical methods Requirements
Requires a BS in biological field and a minimum of 10 years' relevant biotechnology industry experience; or an MS degree with a minimum of 8 years' experience; or a PhD and a minimum of 5 years' of experience Experience with development and qualification of PK/PD and immunogenicity assays in ELISA, MSD and other formats in both human and animal matrices Deep scientific and technical experience with and understanding of therapeutic antibody non-clinical and clinical development Excellent time management skills and the ability to work with a sense of urgency in a highly collaborative team environment Strong oral and written communication including the ability to present information clearly and logically Ability to prioritize and manage multiple projects to meet critical deadlines Strong attention to detail and problem-solving skills Works effectively in a team environment Strong commitment to ethical standards Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) The salary range for this position is commensurate with experience