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Careers Gene Therapy NJ-NYC-PA

VP, CMC – Boston, Philadelphia, NJ, SF

Reporting to the Chief Portfolio Officer (CPO) and Head of Gene Therapy, the Vice President, Gene Therapy CMC will lead a team focused on CMC development of the gene therapy portfolio.  This individual will be a senior leader in the organization and contribute to the company’s research and development efforts to create high value gene therapies to address unmet medical needs for devastating rare diseases. The position will be based out of one of locations in the central NJ/Philadelphia area with laboratory facilities. 

This role is seen as a critical addition to the existing Tech Ops organization currently responsible for overseeing CMC product strategy development and execution of gene therapies, as well as overseeing the complex global network of partners who manufacture and supply clinical and commercial products.  

ROLES AND RESPONSIBILITIES

Primary responsibilities include:

  • Lead, define and build the broad gene therapy technical development and manufacturing strategy with members of the Technical Leadership Team, and  Gene Therapy Leadership Team 
  • Lead the multi-functional team responsible for the development and execution of comprehensive and integrated technical development plans for product portfolio
  • Coordinate and align with the Global Supply Chain leadership to implement the gene therapy supplier network strategy 
  • Direct the design, development, scale-up, and technology transfer of gene therapy manufacturing processes from feasibility test, pilot plant through manufacturing scale
  • Responsible for process development and provides support for process validation in accordance with regulatory guidance
  • Manage the development, implementation, and support of production processes, analytics, control methods and equipment to achieve stage appropriate production of preclinical test article, and early stage clinical trial material
  • Represents the Technical Operations function as a member of the cross-functional Gene Therapy Leadership Team (GTLT) providing strategic guidance to R&D Steering Team on the gene therapy programs and business
  • Work seamlessly with functional and cross functional stakeholders such as Research, Program Management, Alliance Management, Project Management, QC, QA, Regulatory, Manufacturing, Supply Chain and Manufacturing Science & Technology and external collaborators to help advance the portfolio programs through development
  • Key decision influencer on complex issues where analysis of situations and data requires an in-depth knowledge of process development and engineering, factors influencing scale up / scale down of critical process parameters and pharmaceutical production equipment
  • Has accountability for the technical, operational and financial performance of the Technical Development department
  • Is accountable for the alignment of the departmental activities with the activities of the peer departments
  • Provides overall direction to the function and is accountable for departmental deliverables
  • Works with the SVP, Tech Ops and the peer department heads to actively contribute to the gene therapy activities within Tech Ops
  • Coordinates with  the SVP, Tech Ops and the CPO & Head of Gene Therapy to develop and communicate strategic and tactical direction of CMC Development
  • Is recognized as a thought leader internally within and externally within peer communities and uses reputation to enable successful performance of the department
  • Select, develop, and evaluate personnel to ensure the efficient operation of the function
  • Represents the department internally/externally
  • Able to gather internal/external benchmarks for best practices in the scientific field
  • Other responsibilities/activities as may be assigned

ORGANIZATIONAL STRUCTURE

Dual reporting to the Senior Vice President, Technical Operations and CPO and Head of Gene Therapy

QUALIFICATIONS AND BACKGROUND REQUIREMENTS

Educational Requirements

  • Ph.D. in engineering or life sciences

Professional Work Experience 

  • 5+ years direct leadership experience in gene therapy CMC development and manufacturing, bioprocess development or related areas
  • 10 – 15 years of experience of CMC development experience  
  • Experience managing a broad organization, as a leader of leaders
  • Experience with external manufacturing providers, partners, and/or academic collaborations is required
  • Demonstrated ability to successfully manage biologics/gene therapy  programs through technical development, including QbD process characterization and validation, is required
  • A keen ability and desire to grow an organization, mentor our next level leaders, and help manage the dynamics of change
  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • A passion for addressing the critical unmet medical needs of patients

To apply please email resume to jobs@tseworldwide.com