Associate Director/Director, Bioanalytic Development & Operations (Waltham, MA)

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Overview

function googleTranslateElementInit() { new google.translate.TranslateElement({pageLanguage: 'en'}, 'google_translate_element'); } Associate Director/Director, Bioanalytic Development & Operations (Waltham, MA)…

Requirements Summary

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…

Technical Tools

excelms-office

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

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