The Director, CMC Outsourcing Drug Product will be responsible for the biologics drug product and combination product manufacturing of Scholar Rock’s pipeline of products from preclinical through early and late (pivotal) clinical development to commercialization. Successful candidates should enjoy working on multiple internal cross-functional teams, and with external CDMOs. 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 and external (i.e., CDMO) partners to ensure effective delivery of product to meet project needs.

Position Responsibilities

• • Manage CDMOs as the primary point of contact in support of GMP production, including all activities from initial product introduction/tech transfer to manufacturing and release of finished product.
  • Collaborate with the Technical Operations/CMC team to implement drug product and/or combination product production processes at CDMOs.
  • 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.)
  • Lead identification and resolution of business-critical and contract issues, lead escalations to CMC technical and quality leadership.
  • Collaborate with legal and finance teams to manage budget, contracts, and invoices for CDMO activities.
  • Author and review technical documents and regulatory filings; support associated agency interactions and product-related inspections.
  • Collaborate with Quality and Supply Chain to ensure on-time delivery of Drug Product.

Candidate Requirements

• • Bachelor’s degree in a technical or scientific discipline
  • Minimum 10 years of relevant experience in biologics contract manufacturing management, with a focus on drug product and combination product manufacturing for therapeutic parenteral protein products
  • Extensive knowledge of biopharmaceutical drug product manufacturing in multiple formats
  • Proven experience in managing global, external vendors for manufacturing and testing of drug products.
  • Extensive familiarity with phase-appropriate cGMP requirements and FDA, EU, and ICH guidelines
  • Experience with negotiating and executing DP manufacturing contracts and master service agreements.
  • Excellent decision-making, written and verbal communication skills
  • Requires domestic and international travel – up to 25%