Senior Manager/Associate Director, Supply Chain

Location
Branchburg, NJ, United States
Posted
Jul 09, 2021
Ref
2630729760
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
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:

Reporting to the Director, Head of Manufacturing, the Senior Manager/ Associate Director, Supply Chain will be responsible for establishing and leading Century's Supply Chain function for the newly constructed Branchburg, NJ cell therapy manufacturing facility.

This position will play a critical role in the cell therapy Supply Chain and Manufacturing process and has responsibility for developing, implementing, performing, and leading all site-level Supply Chain duties, including Materials Management and Warehouse Operations.

Materials Management includes all aspects of scheduling, procurement and planning of production materials and production operations. Warehouse Operations includes receipt, movement, storage, kitting, and distribution of materials within the manufacturing site, in addition to pack out and shipment of clinical drug product supplies.

Responsibilities:
  • Partner with Engineering and Facilities team during build and fit-out of incoming material and outgoing drug product shipping areas, ensuring Manufacturing and Supply Chain's requirements are met
  • Act as Business Owner of Oracle Inventory Management system, ensuring Manufacturing and Supply Chain's requirements are implemented and validated appropriately during implementation
  • Create, follow, and maintain detailed site plans and procedures for the Materials Management and Warehouse Operations functions
  • Engage with Quality and sourcing partners to identify material suppliers and mitigate supply risks, while ensuring appropriate inventory levels
  • Maintain manufacturing, laboratory, cleaning, and Personal Protective Equipment (PPE) site inventory levels to support day-to-day operations, ensuring business continuity
  • Engage with Clinical Drug Product Delivery Colleagues to manage the scheduling and shipment of outbound drug product
  • Acts as planning and supply chain subject matter expert for site activities relating to new or improvements to supply chain processes and applications
  • Build and maintain a high achieving organization to support early-phase clinical trial cell therapy manufacturing activities for multiple products
  • Foster a collaborative environment that promotes decisive decision making and accountability


Requirements:
  • Superior knowledge of cGMP/Biopharmaceutical regulations
  • Advanced proficiency in purchasing/ planning/ ERP systems and analytics tools
  • Cell therapy experience preferred; experience with gene therapy, biologics, or vaccine development will be considered
  • Proven track record of developing processes and SOPs
  • Proven ability to work effectively in a fast-paced and hands-on environment, and to communicate effectively.
  • Must have the ability to work around laboratories and controlled, enclosed, restricted areas
  • Cleanroom garments and personal protective equipment will be required in designated areas, which cover head, parts of the face, core body, and legs/feet
  • Rigorous adherence to mitigating potential microbial contamination in restricted areas is essential
  • Ability to don appropriate clean room garments and PPE
  • Exposure to sanitization agents is expected and the ability to operating in a clean room environment (an enclosed, restricted space, with assigned pressure and temperature conditions is required)


Qualifications:
  • Bachelor's or Master's degree in supply chain, business management, engineering, life sciences, or related fields
  • 10+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment. Plus 5+ years of direct experience in manufacturing and supply chain areas


Location:
  • This role will be located in Branchburg, NJ and requires the ability to travel domestically (

Show more Show less