CMC Ex vivo Lentivirus, Director

Location: Cranbury, NJ
Travel Requirements: <10%
Relocation Available: Yes

 

Position Summary:

Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. We are seeking a motivated candidate who will be responsible for oversight and management of internal and external stakeholders enabling GMP manufacturing activities for ex vivo lentivirus drug product. A successful candidate will have extensive experience in cell and gene therapy drug product manufacturing with the ability to identify process challenges that can be addressed through design of experiments (DOE) to continuously improve product specifications and yields. The incumbent will collaborate with cross-functional department colleagues working within Rocket Pharma and other partners to ensure the successful execution of Rocket Pharma’s company business strategies and company objectives.

Primary Responsibilities:

  • Lead a small but growing team to support Rocket Pharma’s ex vivo lentivirus pipeline
  • Manage external contract manufacturing organizations (CMOs) and contract testing organizations (CTOs) for the manufacturing and timely release of ex vivo lentivirus drug product
  • Monitor the conformance of ex vivo lentivirus drug product manufacturing to active batch records and regulatory filings
  • Proactively manage conformance issues identified during and after GMP ex vivo lentivirus drug product manufacturing
  • Manage internal and external process development activities
  • Manage technology transfer of modified or new processes to be implemented in GMP manufacturing
  • Manages and communicates ex vivo lentivirus drug product-specific timelines to team members to ensure on-time deliverables are completed for ongoing clinical trials

Education/Experience and Skills Requirements:

  • A minimum of 7-8 years of cell and gene therapy manufacturing experience in the biopharmaceutical industry plus an advanced scientific degree (PhD, PharmD, or MS)
  • Strong management experience (3-5 years)
  • Previous experience with and expert knowledge of cGMP guidelines is essential
  • Excellent attention to detail, communication, time management, organizational skills and flexible attitude with respect to work assignments and new learning with proven ability to interact in a team environment
  • Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information
  • Self-starter and must function well under minimal supervision
  • Expert MS Office skills with a specific focus on word processing, formatting, tables, spreadsheets, presentations, graphics, slides and templates, in addition to Adobe Acrobat

Desired Competencies:

  • Ability to effectively lead
  • Ability to develop and execute strategies
  • Handle issues appropriately and with a sense of urgency
  • Strong leadership to support a multi-project environment in small biotech or large pharma
  • Ability to interact, cooperate and motivate across departments and functions

Contact

Interested in joining our team? Contact us today!

Resumes with cover letters may be submitted to careers@rocketpharma.com