Vice President, Vector Operations - Innovative Gene Therapy

Location
Menlo Park, California
Posted
Mar 16, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Reporting to: Chief Manufacturing Officer

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 Vice President, Vector Operations to lead the global development, manufacture and delivery of lentiviral vectors to support the company’s product pipeline. Such activities will include building and leading the team responsible for development, scale-up, validation and execution of lentiviral vector manufacturing processes and controls to support OTL’s programs from pre-clinical studies through to product commercialization.

Responsibilities

1. Build and lead the OTL team responsible for all aspects of the development, GMP production, fill finish and testing of lentiviral vectors for OTL’s pipeline

2. Ensure the ongoing security of the supply chain for raw materials and intermediates to assure the uninterrupted performance of lentiviral production operations and provision of material for pre-clinical, clinical and commercial programs

3. Identify and enable new technologies and operational modalities to optimize vector operations and improve productivity/yield and/or reduce cost of goods

4. Prepare and maintain departmental budgets

5. Provide senior management representation and liaison with Contract Manufacturing Organizations (CMOs), partners and in-house departments to ensure the successful achievement of company timelines and milestones

6. Implement effective contract lifecycle management and effective benchmarking methods to manage CMOs and external contract services/partners

7. Collaborate with senior management, CMOs and partners to define regulatory strategies and deliver required submission packages

8. Other activities as may be assigned

Job Requirements

The candidate for this position must have:

  • Extensive experience in the biotechnology or pharma industry with a primary focus on upstream cell culture, downstream processing, and fill finish operations for biologics
  • In depth knowledge of lentiviral vector construction and biology
  • In-depth experience of the large-scale cGMP production of lentiviral vectors, including
    • Upstream cell culture, downstream processing, and fill finish operations
    • Process characterization and validation
  • Proven track record of managing lentiviral vector development, validation and production both in-house, and at CMO’s/partners
  • Demonstrated ability to build and lead technical teams in fast-paced operational environments
  • In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements for biologics
  • Knowledge of Quality Systems, QBD and PAT as they relate to GMP production operations, process optimization and process validation
  • Experience of the design, operation and validation of facilities and production equipment for the GMP manufacture and commercialization of biologics
  • The ability to travel domestic and international is a pre-requisite

Education & skills

  • M.S. or Ph.D. in bioprocessing, chemical engineering, vector biology, or biological sciences
  • Proven personnel and project management skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Creative problem solver
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment