Senior Research Associate, Analytical Development - Innovative Gene Therapy Start Up

Location
Menlo Park, California
Posted
May 08, 2018
Required Education
Bachelors Degree
Position Type
Full time

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