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 Limited is a global biotechnology company dedicated to bringing transformative gene therapies to children with severe and life-threatening orphan diseases. The company has been founded in November 2015 and is rapidly expanding its operations in the EU, US and in other regions.

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.

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.

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
  • 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

  • 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
  • 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

Benefits

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, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.

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

RECRUITERS

All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.