Research Associate, Analytical Development - Innovative Gene Therapy Start Up

Menlo Park, California, United States · Analytical Operations expand job description ↓

Description

JOB SUMMARY

The Research Associate/Senior Research Associate, Analytical Development will execute activities associated with the development and validation of analytical methods in support of clinical development and commercialization of Orchard Therapeutics, Ltd.’s innovative gene-modified cell-based therapeutic products

ESSENTIAL FUNCTIONS

  • Conduct release and stability testing of raw materials, process intermediates, ancillary products, drug substances and drug products
  • Conduct experiments in support of qualification/validation of analytical procedures, the transfer of such procedures into internal and/or external QC lab(s), and the setting of appropriate release and stability specifications
  • Provide support for day-to-day activities at contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs), including the review of test records/forms, protocols and reports, deviations/investigations, Standard Operating Procedures (SOPs) and Certificates of Analysis (COAs)
  • Draft SOPs, records/forms and protocols for transfer to internal and/or external QC lab(s)
  • Assist in the preparation of CMC regulatory submissions, including providing data summaries and trend analysis
  • Execute other activities as may be assigned

Requirements

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS

The ideal candidate for this position will have demonstrated in-depth experience with hands-on execution and management of analytical development/QC functions associated with the GMP production and testing of biologic products in an industry setting

Candidate must possess:

  • BS in Biological Sciences, Bioengineering, Chemistry or relevant field plus minimum of 2 years of experience in the biotechnology or pharma industry, with a primary focus on analytical development for biologic products
  • Experience with the application of analytical techniques routinely used to test biologic products, including FACS, High Content Analysis (HCA), HPLC/UPLC, ELISA, Capillary Electrophoresis CE), DNA sequencing/PCR, and/or cell-based assays
  • Demonstrated effective organizational and problem-solving skills
  • Excellent oral and written communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment

In addition, candidate will possess one or more of the following qualifications:

  • Experience with the development and validation of assays used for characterization and QC testing of viral vectors and/or cell-based products
  • Experience interfacing with/managing CMO/CTL relationships and projects
  • Sound understanding and demonstrated application of statistical methods/tools (e.g. SAS, JMP)
  • Knowledge of US and European Pharmacopeia methods and requirements
  • Knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements

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.

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