Sr. Research Associate, Analytical Operations - FM17


Full-time

Menlo Park, California, United States

Analytical Operations

Location: Menlo Park

Reporting to: Associate Director, Analytical Operations

Orchard Therapeutics is a leading global, fully integrated, commercial-stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.

Orchard’s portfolio of ex vivo autologous gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas. These programs include Strimvelis®, the first ex vivo autologous gene therapy approved by the EMA in 2016, 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), transfusion-dependent beta-thalassemia (TDT) and mucopolysaccharidosis type I (MPS-I), as well as an extensive preclinical pipeline.

Orchard is a publicly traded company (NASDAQ: ORTX) with offices in the UK and the US, including London, San Francisco and Boston.

Job summary

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 qualify/validate analytical methods for the characterization, release and stability testing of lentiviral vector products and cell therapy drug product.

Key Elements and Responsibilities

  • Actively contribute to successful development, qualification and execution of robust, state-of-the-art analytical methods for characterization of Lentiviral vector and cell therapy drug product manufacturing processes.
  • Provide analytical support for clinical-scale non-GMP/GMP IND-enabling manufacturing operations, including product characterization and process development studies.
  • 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.
  • Details-oriented, quick learner and with hands-on
  • Ensure high-quality, timely documentation in laboratory notebooks and technical reports.
  • Present data to scientists and management in internal venues (technical and project team meetings).
  • Position requires the ability to stand for extended periods of time and be able to weight appropriate for the skills and abilities listed below.

Requirements

Skills & Abilities

  • Hands on experience in tissue culture, cell-based bioassay, qPCR, ELISA, ddPCR, enzyme activity assay, FACS, and fluorescence -based method development
  • Biological assay including cell Based Potency Assays, ELISA, and FACS
  • Virus titration methods, copy number determination, integration site analysis, and molecular biology techniques, such as qPCR or ddPCR
  • Molecular biology assay including qPCR and ddPCR
  • Strong ability to analyze complex data in a quantitative and objective manner
  • Comfortable in a fast-paced company and able to adjust workload based upon changing priorities
  • GMP experience or knowledge preferred
  • Experience with automated liquid handling equipment and procedures desired

Education & Experience

  • B.S. in Life Sciences field
  • 3-5 years of experience in a development role within the pharmaceutical or biotechnology industry OR M.S. in Life Science field with 1-3 years of experience in an analytical development role in the pharmaceutical or biotechnology industry

Benefits

Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify