Senior Research Associate, Drug Product Characterization - AOQC8
Menlo Park, California, United States
Orchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare disease through innovative gene therapies.
Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the European Medicines Agency for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for neurometabolic disorders, primary immune deficiencies and hemoglobinopathies include three advanced registrational studies for metachromatic leukodystrophy (MLD), ADA-SCID and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and transfusion-dependent beta-thalassemia (TDBT), as well as an extensive preclinical pipeline.
We are seeking an innovative, motivated and results-oriented candidate, who thrives on increasing levels of responsibility. You will be joining a dynamic team responsible for the development and characterization of clinical-scale manufacturing processes for therapies. The successful candidate will help to develop, optimize and validate analytical methods for the characterization, release and stability testing of lentiviral vector products and cell therapy drug product.
- Actively contribute to successful development, qualification and execution of robust, state-of-the-art analytical methods for characterization of lentiviral vector products and transduced cell therapy drug products.
- Provide analytical support for clinical-scale non-GMP/GMP IND-enabling manufacturing operations, including qualification of in-process and release methods and tech transfer internally and externally in support of GMP manufacturing and release of clinical material.
- Significantly contribute to relevant and impactful innovation programs to enhance product characterization technologies.
- Contribute to project technical teams to ensure effective integration at all levels. Communicate and collaborate effectively.
- Demonstrate strong accountability as well as good organizational and interpersonal skills.
- Detail-oriented, quick learner and with hands-on laboratory acumen
- Draft high-quality Standard Operating Procedures, Test Methods, protocols and reports in a timely fashion.
- Present data to scientists and management in technical and project team meetings.
- BS/MS degree in Cell Biology/Biochemistry/Immunology or related field with 3+ years of experience in biotech/ biopharma industry (Experience in the development of analytical methods for the characterization of gene- or cell-based therapies would be a strong bonus). PhD degree in the similar field with 0+ years of experience is also desired.
- Proficiency in design/analysis of multicolor flow cytometry experiments is highly desired.
- Experience in cytometry and magnetic based cell sorting is highly desired.
- Experience with hematopoietic stem cell (or other stem cell) systems (culture, analysis, transplantation) is highly desired.
- Experience with lenti-viral vector transductions is a plus
- The individual will work with their manager and the team to design and plan laboratory experiments to be conducted independently
- Candidate will apply advanced scientific knowledge to complete projects.
- Ability to work flexibly in a fast-paced, changing environment; must be ready accept responsibilities outside of the initial job description
- Experience in assay design, optimization, validation, experimental design, data analysis, and data presentation is desired
- Ability to handle multiple tasks efficiently, capable of critical thinking, as well as data analysis and interpretation
- Good interpersonal, verbal, and written communication skills
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plan. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.
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