Director / Project Manager - Contract Manufacturing

Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.  We are creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia.  
 
Scholar Rock’s newly elucidated understanding of the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.  By developing product candidates that act in the disease microenvironment, we intend to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Our lead product candidate, SRK-015, is being developed for the treatment of patients with Spinal Muscular Atrophy (SMA).
 
Summary of Position:
We are seeking an individual who is exceptional problem solver and will thrive in a team oriented, innovaive and creative environment. This position is responsible for directing the development and GMP production at a CDMO. This is an exciting and critical department at Scholar Rock. Areas of responsibilities include overseeing development efforts of an antibody at the CDMO and managing timelines, contracts, and budgets. This position must be able to communicate clearly and effectively the CMC project expectations internally to SR and externally to CDMO. 
 
Position Responsibilities: 
  • Coordinates overall CMC project plans and prioritize tasks.
  • Oversees CDMO development efforts for CLD and USP/ DSP process 
  • Directs the IP, release and characterization testing to be performed at the CDMO and reviews assay development, method qualification and testing at CDMO.
  • Monitors GMP production and is able to communicate potential concerns internally and to CDMO.
  • Ability to trouble shoot and offer sound scientific advice on assays and processes.
  • Monitors progress of project to ensure on-time milestone and budget completion while ensuring high quality deliverables are provided to SR.
  • Able to troubleshoot scientific problems with minimal assistance. 
  • Consistently seeks and promotes innovative solutions or approaches to problem solving, from a technical and functional viewpoint in a highly flexible and interactive manner as scientific data reveals new information or requirements evolve or change.
  • Demonstrated ability to drive projects and overcome obstacles.
  • Direct CMC effort on the development team. Manage budget and contracts   
  • Ability to foster collaborative partnerships with CDMOs.
  • Demonstrates ability to interact with and build relationships at many levels of the organization internally and externally to accomplish objectives.  
  • Excellent communication skills with an emphasis on the ability to interact in a positive manner with all levels of internal and client employees and management.
  • Travel to CDMO approximately 10-20%.
 
Candidate Requirements:
  • B.S. in Science or Engineering required.  Advanced degree (M.S. or  PhD) is preferred
  • 3+ years direct experience managing projects required
  • Working knowledge of Biologics Fermentation, Cell Culture, Purification and Analytics for large molecules
  • 8+ years professional experience in a related field such as Biotechnology, Pharma preferred
  • Experience in Biologics Contract Manufacturing preferred

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