Associate Director/Director, Bioanalytic Development
5 days ago
Associate Director/Director, Bioanalytic Development & Operations (Waltham, MA) 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 department's 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 reagents 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 #J-18808-Ljbffr
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Waltham, United States Dyne Therapeutics Full timeExecutive Director, Bioanalytical DevelopmentDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic...
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Waltham, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...
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Executive Director, Bioanalytical Development
6 hours ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...
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Waltham, Massachusetts, United States Upstream Bio Full timePosition Summary:The translational Sciences group at Upstream Bio is looking for a Principal Scientist/Associate Director, Bioanalytical Sciences who will lead the development and implementation of critical bioassays to support development programs and provide scientific and operational oversight of bioanalytical sample analyses.You will represent the...
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Senior Bioanalytical Development
5 days ago
Waltham, United States Cedent Full timeA biotechnology company is seeking an Associate Director/Director of Bioanalytic Development & Operations in Waltham, MA. This role requires leadership in the development and validation of bioanalytical techniques for clinical studies. Candidates must possess a relevant degree and extensive industry experience. Responsibilities include coordinating studies,...
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Director, Bioanalytical Strategy – Hematology
3 weeks ago
Waltham, United States CSL Plasma Inc. Full timeA biotherapeutics leader in Waltham is seeking a Director of Clinical Assay Strategy to lead bioanalytical and biomarker assay strategies. The role involves developing innovative project solutions, overseeing compliance, and managing a specialized team. Candidates should have extensive experience in clinical biomarker assays and be capable of collaborating...
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waltham, United States CSL Behring Full timeCSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide....
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Waltham, United States CSL Behring Full timeCSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference...
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Waltham, United States CSL Full timeCSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference...
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Waltham, United States CSL Behring Full timeCSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide....
