Associate Director, Bioanalytical Lead and Non-Clinical Development Operations
The Associate Director, Bioanalytical Lead and Non-Clinical Development Operations is a broad role within the Nonclinical Development Department for bioanalytical scientific lead and general study management in support of Disc Medicine’s drug development.
- Serve as the bioanalytical subject matter expert (SME) for assigned programs/studies to provide bioanalytical solutions to achieve program milestones.
- Serve as the liaison between internal teams and CROs for PK (large and small molecules), ADA and biomarker support for non-GLP/GLP/Clinical studies.
- Establish/follow internal processes/workflows to manage samples, methods, data, reports, contracts, budgets for studies within the non-clinical development organization.
- Interact with cross-functional teams within Disc Medicines to provide other operational support for nonclinical development.
- Collaborate with CROs to address operational needs for contracts, samples, data, and reports to meet project timelines.
- PhD in bioanalytical chemistry, biology, immunology or a related field.
- 8+ years’ experience of working in the pharmaceutical/biotechnology industry, with a focus on bioanalysis of biologics.
- Demonstrated expertise in bioanalysis for monoclonal antibody, protein drugs, ADA and biomarkers with excellent tracked records is required.
- Hands on experience in developing and validating ligand binding assays is a required.
- Experience in generating cell lines and working on cell-based bioanalytical assays (e.g., neutralizing antibody assays) is desired.
- Experience in working with relevant functions/CROs to generate critical reagents to support immunoassays is a plus.
- Experience in working in/with CROs is plus.
- Excellent written and communication skills.
- Excellent CRO management skills and willingness to be hands-on.
- Working experience in GLP environment in supporting toxicology and clinical studies, familiar with regulatory guidance in bioanalytical field is a plus.
ABOUT DISC MEDICINE
Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.
Interested in joining our team? Please contact us at firstname.lastname@example.org
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