Manager, Analytical Operations (Europe) - AOQC6


Full-time

London, England, United Kingdom

Analytical Operations

Location: London, UK

Reporting to: Director, Analytical Operations (Europe)

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 suitable candidate to manage activities related to the development, validation and implementation of analytical methods for the testing, lot release, stability, and characterization of OTLs innovative gene-modified cell-based therapeutic products. More specifically, working with OTLs designated European Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs) this individual will manage activities to provide analytical support to facilitate the progression and maintenance of OTLs product pipeline programs.

Requirements

Responsibilities

  • Oversee 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)
  • Oversee QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, SOPs and Certificates of Analysis (CoAs)
  • Oversee the execution of stability programs for raw materials, ancillary products, drug substances and drug products
  • Drafting and review of SOPs, records/forms and protocols for 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

Benefits

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