CRISPR Therapeutics Scientist/Senior Scientist – Analytical Development (Flow Cytometry) in Cambridge, Massachusetts
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.
Flow cytometry team lead to oversee the design and execution of immunophenotyping assays for the characterization of cell and gene therapy products.
Develop and optimize flow cytometry assays. Design and execute plans for method qualification per ICH and regulatory guidelines.
Supervise and manage a team for assay development and testing activities to support various CRISPR programs.
Generate, manage, evaluate, and maintain critical data in a highly organized manner, providing statistical analysis and troubleshooting where appropriate.
Collaborate with Process Development team to generate and analyze process development data to develop an understanding of cellular product critical quality attributes to guide testing and process control strategies.
Interact with CMOs and other vendors as required to support method transfer and validation activities
Cross functional and highly visible position within Technical Operations group. Position requires active collaboration with research, process development and quality teams.
Support analytical sections of regulatory filings for US, Europe and ROW.
MS/ Ph.D. in cell biology, immunology, molecular biology, or related sciences with 8+ (MS) or 4+ (Ph.D.) years of relevant experience is required. Title and responsibilities will be based on experience.
Extensive experience in flow cytometry and immunophenotyping assays. Expertise in flow cytometry data analysis. Proficiency in related immune-assay techniques such as MSD and ELISA.
Must have strong organization skills, and ability to multi-task in a fast-paced environment with changing priorities. Must be able to work effectively as part of a multi-disciplinary team.
Must be independently motivated, detail oriented with good problem-solving ability.
Strong writing, reviewing, and presentation skills is required.
Previous experience of managing/mentoring associate scientists is required.
Experience of working with and managing external vendors/ CROs is preferred.
Background or experience in T cell biology or immuno-oncology.
Experience with qualifying and validating assays and understanding of ICH/ FDA guidelines is strongly desirable.
Understanding or experience of method transfer to a GMP testing lab is a plus.
Understanding of statistical tools, such as JMP, DoE, Prism etc. is a plus.
Knowledge or experience of manufacturing cell and/or gene therapy products from whole blood, apheresis, or bone marrow is highly desirable.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified 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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