Skip to Content

Manager Human Therapeutics

Intrexon Corporation, Germantown, Maryland

Position Description:
The Manager, CMC Biologics will champion the effort of lead candidates for IND/BLA submissions including development of scalable biological process routes and manufacture of GMP supplies of biologics in support of preclinical and clinical studies. The Manager will also participate in efforts for our lead candidates for Health Sector initiatives with regards to supporting technology transfer to CMOs and process development that are in alignment with division requirements and their products which are governed by specific regulatory operations. The ideal candidate will have experience with gene modified T cell products (CAR-T, TCR), non-viral and viral vector products, and gene therapy design. Periodic travel required.

Duties and Responsibilities:

  • Coordinate Clinical Studies in support of Intrexon partnered programs.
  • Design of early product definition involving formulation, process development, analytical development and delivery.
  • Be a resource for R&D with reference to analytical and formulation (DS and DP) and delivery issues.
  • Preparation of CMC sections for regulatory submissions (IND, BLA), invention disclosures, progress reports, and publications.
  • Formulations chemistry design and application for Intrexon's pipeline of biological based products.
  • Identification of contract manufacturing organizations qualified to perform process development and GMP manufacture of biologics.
  • Preparation and execution of technology transfers with CMOs.
  • Manage the development and execution of process improvements and scale-up efforts, and supervise CMOs in implementing them for GMP clinical material manufacturing.
  • Along with QA/QC, adhere to Quality Agreements with CMOs.
  • Maintain a high level of knowledge in gene and cell therapy, particularly in the field of CAR-T product development and manufacturing.
  • Collaborate with other departments to eventually develop biologics for commercial production in support of IND/BLA applications.
  • Presents updates to project teams on both development and manufacturing activities.
  • Represent Intrexon to CMO partners.
  • Identification of CMO partners and best of class CMO partners.
  • Work within the quality organization in identifying, collaborating and implementing appropriate process fit for technology transfers to CMOs that fall within guidance of regulatory agencies.

Education and Experience:

  • Degree in Chemical Engineering, Molecular Biology, Analytical Chemistry, Pharmaceutical Sciences or equivalent with 5+ years' experience in large molecule/protein biotech development with particular experience with gene modified T cell products (CAR-T, TCR), non-viral and viral vector products, and gene therapy design.
  • Experience and knowledge in GMP cell therapy product manufacturing operations.
  • Experience with CMC leadership and development.
  • Experience with late stage CMC development (PH1/PH2/Ph3/NDA/MAA/BLA) into commercialization.
  • Experience with early stage CMC development (pre-IND, IND, BLA.)
  • Extensive knowledge of phase-specific, global CMC practices and regulatory requirements.
  • Experience with vendor management and technology transfer.

Desired Key Competencies:

  • Excellent communication skills.
  • Self-motivated and independently minded.
  • Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.
  • Self-organizer, meticulous hands-on habits, keen attention to detail.
  • Strong quantitative and analytical skills.
  • Responsive, can-do attitude.
  • Can coordinate parallel tasks across multiple projects, demonstrating prioritization.
  • Ability to quickly adapt to a rapidly changing environment and demands.
  • Ability to interpret and effectively execute upon a variety of instructions provided in written, oral, diagram or schedule formats.

To Apply:
For more information and to apply online, please click here