Associate Director, Supply Chain & Logistics - Innovative Gene Therapy Start Up - Menlo Park


Full-time

Menlo Park, California, United States

Supply Chain

Reporting to: Senior Director, Supply Chain Operations

Location: Menlo Park, California

Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients through innovative gene therapies.

We are looking for an Associate Director to oversee the implementation and execution of Supply Chain and Logistics Operations to support commercialization of OTL’s products. Such activities will include the design and implementation of integrated processes and procedures for the coordinated accession, manufacture, storage and distribution of OTL’s cryopreserved autologous, hematopoietic stem cell-based gene therapy products and starting materials.

RESPONSIBILITIES:

  • Design and implement processes and procedures to ensure effective and compliant clinical and commercial supply chain operations
  • Lead coordination with OTL’s Technical Operations, Clinical and Commercial Departments to Schedule:
    1. The harvest, packaging and collection of each patient’s bone marrow or peripheral blood at the designated hospitals/clinical centers for delivery to the designated manufacturing facility
    2. The delivery of OTL’s critical raw materials to the designated manufacturing location
    3. The manufacture and release of autologous gene therapy product at the designated manufacturing facility
    4. The packaging, collection and on time delivery of the autologous gene therapy product from the manufacturing facility to the designated hospital/clinical center for the scheduled patient administration
    5. The administration of the autologous gene therapy product to the patient at the designated hospital/clinical center
  • Oversee service agreements/contracts and manage logistics for the:
    1. Packaging, collection, tracking and cold chain delivery of autologous bone marrow and peripheral blood product harvests from the designated hospitals/clinical centers to the designated manufacturing sites
    2. Packaging, collection, tracking and shipment of cryopreserved autologous, hematopoietic stem cell-based gene therapy products from the manufacturing site back to the hospital/clinical center for administration into the patient
    3. Distribution of critical raw materials for OTL’s manufacturing processes
  • Ensure all required Import/Export documentation is available
  • In collaboration with Quality Assurance and other relevant departments, conduct the investigation, reporting and closure of deviations and associated CAPAs
  • Develop Key Performance Indicators for supply chain activities, trend data and provide recommendations for improvements and cost reduction to senior management
  • Other activities as may be assigned

Requirements

JOB REQUIREMENTS:

The ideal candidate for this position will have:

  • Experience in clinical and commercial supply chain management preferably with cell and gene therapy products
  • Proven track record of supply chain planning, materials/inventory management, and business process facilitation, including:
  • o Experience with supplying global clinical trials and commercialization o Management of vendors for Cold Chain Storage, Packaging, Tracking and Distribution o Experience importing and exporting human cell and gene therapy products for use in clinical trials
  • Cell and gene therapy product experience a plus
  • In-depth knowledge of import and export requirements for countries in which OTL’s products are commercialized/distributed
  • In-depth knowledge of FDA, EMA, GMP, GCP and ICH regulatory requirements

EDUCATION & SKILL REQUIREMENTS:

  • BS degree or equivalent in a scientific discipline
  • Proven personnel and project management skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment

Benefits

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify

Notice to RECRUITERS: All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.