Project Manager - External Manufacturing

Cambridge, MA /
Technical Operations /
Full-Time
Scholar Rock is a clinical-stage biopharmaceutical company creating a robust pipeline of therapeutics with the potential to transform the lives of patients suffering from serious diseases, including neuromuscular disorders, cancer, fibrosis, and anemia. Our proprietary platform is rooted in our structural biology insights into the activation of latent growth factor precursors and drives the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.  By exploiting structural differences in the precursor, or latent form of growth factors, Scholar Rock intends to avoid the historical dose-limiting safety challenges associated with inhibiting the mature form of growth factors for therapeutic effect.
 
Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation currently being evaluated in a Phase 2 proof-of-concept trial for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). SRK-015 has received Orphan Drug Designation in both the US and EU.
 
Our second product candidate, SRK-181, is a potent and highly selective inhibitor of latent TGFβ1 activation.  A Phase 1 proof-of-concept trial was initiated in April 2020 in patients with solid tumors. We believe SRK-181 has the potential to meaningfully increase the number of patients who can benefit from checkpoint inhibitor therapy by overcoming primary resistance to anti-PD-(L)1 antibodies.


Summary of Position:

We are seeking an individual who is exceptional problem solver and will thrive in a team oriented, innovative and creative environment. This position will be responsible for managing the technical development plan and operations department interfaces (internal and external at CDMOs). This position will work closely with the operations, clinical, preclinical, quality, and regulatory teams to meet program milestones.  

Responsibilities:

    • Oversees development and manufacturing efforts of Scholar Rock’s products at CDMO(s)
    • Works independently and with the team to develop and maintain cross-functional CMC development plans from early phase through product launch
    • Coordinates and aligns CDMO and CMC project plans and prioritize tasks
    • Monitors progress of projects to ensure on-time milestone and budget completion while ensuring high quality deliverables are provided to Scholar Rock
    • Troubleshoots scientific/technical 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
    • Fosters collaborative partnerships with CDMOs
    • Interacts and builds relationships at many levels of the organization internally and externally to accomplish objectives
    • Uses several channels to interact in a positive manner with all levels of internal and CDMO employees and management
    • Travel to CDMO approximately 10-20%

Requirements

    • B.S. in Science or Engineering required.  Advanced degree (M.S. or  PhD) is preferred
    • 8+ years professional experience in a related field such as Biotechnology, Pharma preferred
    • 3+ years direct experience managing projects required with the demonstrated ability to drive projects and overcome obstacles
    • Excellent communication skills with a track record of efficiently communicating with internal stakeholders as well as external partners
    • Experience in Biologics Contract Manufacturing
    • Working knowledge of Biologics Drug Substance Purification process development and manufacturing of large molecules
    • Working knowledge of Drug Product development and manufacturing preferred
    • Experience in late-stage clinical programs preferred
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees