Senior Associate, Analytical Quality Control - Innovative Gene Therapy Start Up

Foster City, California, United States · Quality Control expand job description ↓

Description

This an exciting opportunity for a qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Orchard Therapeutics, Ltd. (OTL) is looking for a Senior Associate to assist in the set-up of a new in-house Analytical Quality Control (QC) laboratory function and to subsequently execute methods for the testing, lot release and characterization of OTLs innovative gene-modified cell-based therapeutic products and pipeline programs.

Responsibilities

  • Execution and review of release testing of raw materials, process intermediates, ancillary products, drug substances and drug products
  • Completion and review of test records/forms, final reports, SOPs and Certificates of Analysis (CoAs)
  • Execution and reporting of stability programs for raw materials, ancillary products, drug substances and drug products
  • Drafting of SOPs, records/forms and protocols for in-house QC testing
  • Support CMO production activities by coordinating testing activities with appropriate external and in-house departments
  • Other activities as may be assigned


Requirements

Job Requirements

This candidate will possess:

  • Minimum of five years of experience in the biotechnology or pharma industry with a primary focus on the analytical QC testing of complex biologics
  • Experience with the validation and implementation of analytical techniques in a QC environment, including FACS, High Content Analysis (HCA), ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, cell culture and cell-based assays a plus
  • Experience of the characterization and QC release testing of viral vector-based and/or cell-based products a plus
  • Sound understanding and demonstrated application of statistical methods/tools
  • In-depth knowledge of US and European Pharmacopeia methods and requirements
  • In-depth knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements
  • Some domestic and international travel may be required

Education & skills

  • A minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills

Creative problem solver

Ability to operate in a fast-paced, multi-disciplinary industrial environment

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