Director, Quality Control - Gene Therapy

Location
Foster City, California
Posted
Oct 17, 2017
Required Education
Bachelors Degree
Position Type
Full time

This an exciting opportunity for a well-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 Director, Quality Control (QC) to set-up a new in-house laboratory function as well as manage the interface for QC testing at OTLs designated Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs). More specifically, the individual will manage activities related to the implementation of analytical methods for the testing, lot release and characterization of OTLs innovative gene-modified cell-based therapeutic products and pipeline programs.

Responsibilities

  • Establish, organize, staff and manage an in-house analytical QC laboratory
  • Execution, review and approval of release testing of raw materials, process intermediates, ancillary products, drug substances and drug products
  • Manage activities at CMOs and CTOs for the implementation of analytical methods, including the design, review and approval of protocols, test records/forms, final reports and Standard Operating Procedures (SOPs)
  • Manage QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, SOPs and Certificates of Analysis (CoAs)
  • Establish and oversee/execute stability programs for raw materials, ancillary products, drug substances and drug products
  • Drafting and review of SOPs, records/forms and protocols for in-house QC testing and overall analytical operations
  • Support CMO production activities by coordinating testing activities with appropriate external and in-house departments
  • Assist in the preparation of CMC regulatory submissions
  • Other activities as may be assigned

Job Requirements

As a proven analytical QC expert with significant applied experience in the biotechnology industry, this candidate will possess:

  • Extensive experience in the biotechnology or pharma industry with a primary focus on the analytical QC testing of complex biologics
  • Experience of the characterization and QC release testing of viral vector-based and/or cell-based products a plus
  • 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
  • Experience of managing CMO/CTO relationships and projects
  • 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

The ability to travel domestic and international

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