Associate/Director, Drug Product Development

Location
Philadelphia, PA, United States
Posted
Dec 16, 2020
Ref
2329082133
Required Education
Associate Degree
Position Type
Full time

Position Title: Associate/Director, Drug Product Development

Reports to: Sr. Director, Process & Product Development

Location: Philadelphia, PA

Company:

Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of current cell therapies. Century's genetically-engineered, universal iPSC-derived immune effector cell products are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care.

Century's foundational technology is built on induced pluripotent stem cells (iPSCs) that have unlimited self-renewing capacity. This enables complex cellular engineering to produce controlled cell banks of modified cells that can be expanded and differentiated into desired immune effector cells, which can supply vast amounts of allogeneic, homogeneous therapeutic products. This platform differentiates Century from other approaches that utilize non-renewable donor-derived cells.

Role:

The Director, Drug Product Development will leverage experience in parenteral formulation and aseptic process development, preferably with clinical-stage cell therapy programs, to build and lead this critical function at Century. Key responsibilities include, but are not limited to, the development, characterization/validation, and transfer of formulation and fill-finish unit operations (including ancillary materials, cryo-preservation, shipping and storage procedures) to GMP facilities. The ideal candidate will serve as a subject matter expert, design and execute lab experiments toward drug product optimization, provide operational support, draft regulatory submissions, and interact effectively with internal (e.g., Clinical Development) and external (e.g., CDMO, consultant) stakeholders. The incumbent will have the opportunity to lead a small team of scientists in a dynamic start-up environment.

Key Responsibilities:

 

  • Develop and implement a Drug Product Strategy capable of supplying clinical trials with iPSC-derived material complying to quality targets, current Good Manufacturing Practices (cGMP), and regulatory requirements.
  • Support the delivery of Century's engineered immune cell portfolio by drafting regulatory submissions and serving as functional representative on project teams.
  • Identify novel solutions to address key technical challenges required for manufacturing platform success, such as cryo-preservation, fill-finish process scale-up and capacity (future automation).
  • Design appropriate shipping and storage procedures adequate for drug product distribution. Ensure compatibility with clinical administration procedures.
  • Outline experimental strategy toward cryo-formulation development, as well as characterization and validation of delivery protocol for clinical supplies.
  • Collaborate with internal and external groups to integrate drug product technology in GMP facilities.
  • Define scientific agenda and manage research activities of junior lab members and interns/co-ops.
  • Maintain laboratory procedures, systems and notebooks, to ensure documentation of research activities.
  • Domestic travel up to 25%.

 


Professional Experience/Qualifications:

 

 

  • Functional experience in drug product development, including formulation development, aseptic techniques, and cryo-biology.
  • Understanding of characterization/validation concepts, cGxPs, and CMC regulatory requirements.
  • Ability to manage and deliver high-profile projects, and to transform corporate objectives into team goals.
  • Proven track record in biological drug product development e.g., therapeutic proteins, vaccines and/or cellular therapies (highly desirable).
  • Extensive experience with cell cryopreservation, parenteral formulation, aseptic operations, process scale-up/down, characterization, technology transfer.
  • Understanding of cell biology/physiology and/or engineering fundamentals. Experience with induced pluripotent stem cells (iPSC) is preferable.
  • Equipment development and qualification in cGMP environment e.g., IQ/OQ/PQ.
  • Experience with regulatory submissions e.g., IND, BLA.

 


Education:

PhD in pharmaceutical sciences, biochemistry, biochemical engineering, or a relevant field, with a minimum of 8 years of industry experience. Or BS/MS with 12-16 years relevant professional experience.

Compensation:

An attractive compensation package commensurate with this senior leadership role will be provided.

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