Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary:
The Manager/Sr. Manager, Bioanalytical Sciences manages CRO-outsourced bioanalyses for Cullinan Therapeutics clinical studies including PK, ADA, and NAb sample testing for various therapeutic modalities including bispecific antibodies and fusion proteins. S/he also provides critical reagent sourcing and life cycle management support according to program needs and therapeutic modality. This role works cross functionally with Clinical Pharmacology, Translational Research, CMC, Supply Chain, Data Management, and Regulatory.
- Manages clinical bioanalytical sample testing contracts, POs, and expenditures in accordance with sample shipments from clinical sites and the central lab to laboratory sites for testing.
- Collaborates with clinical operations and the central lab to provide appropriate clinical laboratory manuals and support sample management and logistics.
- Supports CRO and vendor selection including capability assessments.
- Supports critical reagent life cycle management.
- Makes recommendations for appropriate therapeutic specific reagents to support PK, ADA, and NAb assay development.
- Comply with GXP regulations and regulatory standards in bioanalysis and internal Cullinan standards.
- BS, MS, or PhD degree in biological sciences or a related discipline and a minimum of 6 years of relevant work experience.
- Industry experience managing sample analysis for biologics, PK, ADA, and NAb.
- Experience with critical reagent life cycle management.
- Strong background in molecular biology and biophysical characterization of proteins.
- Understanding of PK, ADA, and NAb ligand binding and cell-based assay development.
- Experience with providing clinical bioanalytical support for biologics.
- Knowledge and experience in GLP/GCP requirements and practices in the bioanalytical lab.
- Excellent communication, organizational, documentation, and technical writing skills required.
Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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