Director, Analytical Operations - Innovative Gene Therapy Start up

Location
Menlo Park, California
Posted
Jan 12, 2018
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 an Associate Director/Director, Analytical Operations to manage activities related to the development, validation and implementation of analytical methods for the testing, lot release and characterization of OTLs innovative gene-modified cell-based therapeutic products. More specifically, working with OTLs designated Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs) and an in-house team this individual will manage activities to provide analytical support to facilitate the progression of OTLs product pipeline programs.

Responsibilities

  • Manage the analytical functions associated with the development, GMP production and testing of OTLs products
  • 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 development, qualification and 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 technical expert in the development, manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry, this candidate will possess:

  • Minimum of 10 years of experience in the biotechnology or pharma industry with a primary focus on the development, validation and application of analytical methods for product development, characterization and QC testing
  • Experience of the characterization and QC release testing of viral vector-based and/or cell-based products a plus
  • Experience with the development, validation and application 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

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