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The Molecular Pathology group within Non-clinical Drug Safety (NDS) for Development at Leading Pharmaceutical Company is seeking a talented scientist to join their team at the Ridgefield, CT, site. The Molecular Pathology laboratory uses state-of-the-art methods integrating histopathology with current molecular and imaging techniques. The primary function of the team is to provide new assays, biomarkers, and data to support drug safety decisions.
The main responsibility of this position is to develop and apply methods for tissue-based molecular endpoints. Major assay types for this group include immunohistochemistry (IHC), in situ hybridization (ISH), and immunofluorescence (IF). Key portfolio deliverables are tissue cross-reactivity and target tissue distribution studies. Elements of this work include scheduling and securing needed reagents, interfacing with other research, histology, and toxicology teams, transferring methods for Good Laboratory Practice (GLP) studies, and preparing technical reports for molecular pathology studies.
General expectations for this role are to perform routine lab duties with minimal supervision, participate/assist in the design and execution of non-routine experiments, and perform all work in a safe manner and in conformance with applicable regulations. The scope of responsibility is primarily within the laboratory environment and immediate discipline.
As an employee of Leading Pharmaceutical Company, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Leading Pharmaceutical Companys high regard for our employees.
Duties & Responsibilities:
Develop and transfer methods for tissue cross-reactivity studies Ensure all needed reagents, tissues, and control materials are ordered and received in a timely fashion; oversee labeling and characterization of reagents as needed; conduct IHC assays and confirm that methods are optimized and fit-for-purpose; review immunolabeling with project pathologists; and write method development reports for transfer to Contract Research Organizations.
Coordinate and conduct target tissue distribution studies Oversee ordering and validation of antibodies and control reagents; optimize and troubleshoot IHC, ISH, and IF assays as needed; work with project pathologists to characterize target expression; and write methods for study reports.
Develop and implement new assays and biomarkers -- Develop, conduct, and optimize novel tissue -based assays; support use of enhanced safety or mechanistic endpoints in NDS non-clinical safety evaluations; and propose new assays, techniques, or approaches based on current information.
Document work activities and study records completely and accurately -- Maintain records for all laboratory work in accordance with study protocols by following applicable company policies, using current forms and procedures, and making all entries legibly, correctly and contemporaneously; and perform all work safely and in compliance with all applicable regulations, standard operating procedures, company policies, safety training and procedures.
Initiate and complete routine procedures in an independent and efficient manner, with minimal supervision; independently operates and is responsible for lab equipment; troubleshoots effectively.
Demonstrate technical ability to assist in the design and execution of non-routine experiments with supervision.
Apply basic scientific principles with minimal guidance; performs literature searches and extracts relevant information from published protocols.
Demonstrate the ability to interpret outcome of experiments and to propose appropriate follow-up work.
Communicate own work effectively orally and in writing, including input for protocols, procedures, and technical, and other scientific reports.
Report and treat data with a high level of integrity and ethics.
Comply with applicable regulations and perform all work in a safe manner; maintain proper records in accordance with SOPs and policies.
Bachelor s Degree with 3+ years of experience in related scientific discipline or Master s Degree in related scientific discipline or equivalent experience in related field.
Hands-on experience in tissue-based assay development and optimization, data analysis, and interpretation, including 3+ years of experience in IHC and/or ISH methods development in a laboratory environment.
Knowledge and experience in the principles and approaches for development of IHC, ISH, and IF assays, including antibody validation and reagent characterization.
Ability to work independently to achieve key study milestones and meet project goals.
Strong written and verbal communication skills, including concise and accurate reporting of study information.
Ability to wear respiratory and eyewear protection, and access laboratory equipment on bench tops or equivalent while using both hands to perform manual dexterity operations.
Desired competencies include histology skills, understanding of toxicology/safety biomarkers, and familiarity with platforms for multiplex IHC/ISH/IF assays and digital image analysis.
Appropriate level of understanding of applicable regulations.
No known allergies to animals
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