Senior CMC Project Manager
- Scholar Rock Inc.
- Full time
- Cambridge, Massachusetts
- Posted: February 22, 2023
Company
Scholar Rock is a Phase 3, 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.
Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is 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, and fibrosis.
Summary of Position:
The Senior CMC Project Manager for Technical Operations will be responsible for the management of CDMOs for global clinical studies in various phases of development. Successful candidates should enjoy working on multiple internal cross-functional teams, and with external CMOs. Reporting to the Senior Director, CMC Outsourcing and Supply Chain, this position is primarily responsible for managing the day-to-day operations and communications with internal partners and CDMOs to ensure effective delivery of product to meet project needs.
Position Responsibilities:
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- Manage one or more CDMOs as the primary point of contact in support of GMP production of Scholar Rock products, including activities from initial cell banking to fill/finish.
- Ensure that all contractual obligations with our CDMOs are met to Scholar Rock Quality standards, including on-time manufacturing, QC release testing and batch disposition
- Establish business processes and cross-functional relationships with internal and external partners, including senior leaders at the CDMO
- Communicate status of projects and activities at CDMOs to Scholar Rock management and stakeholders
- Work with legal and finance groups on contracts for new and existing vendors (i.e., supply agreements, confidentiality agreements, purchase orders, etc.)
- Manages budget, contracts, and invoices for CDMO manufacturing activities.
- Manages internal and external inventory of product retains and samples
- Collaborates with Supply Chain to ensure on-time Drug Substance and Drug Product availability and provides forecast data for inventory maintenance
- Develop, review and approve technical manufacturing documents such as production records, distribution instructions, and specifications.
- Contribute to the development of study and product specific documents, including MSDS sheets and other technical documents as required
- Other duties may be assigned
Candidate Requirements:
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- Bachelor’s degree in a technical or scientific discipline
- Minimum 8 years of relevant experience in biologics contract manufacturing management
- Working knowledge of cGMPs and pharma industry procedures and regulations
- Experience working with CMO DS and DP operations
- Experience working with FDA and other global health authorities
- Demonstrated excellence in project management—managing, tracking, and measuring project progress
- Requires domestic and international travel – up to 25%
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.