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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing outsourced manufacturing operations within the biopharmaceutical industry, focusing on CMC development, regulatory compliance, and supplier relationship management. Proven ability to lead complex projects, negotiate contracts, and ensure adherence to GMP and regulatory standards.
Highest-signal resume keywords
CMC Development ManagementGMP ComplianceSupplier Relationship ManagementNegotiation SkillsGlobal Supply Chain Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Drug Substance ManufacturingDrug Product ManufacturingProcess Scale-UpTechnology TransferQuality AgreementsInventory ManagementProduction PlanningLogistics ManagementRegulatory ComplianceKPI Implementation
Soft Skills
Negotiation AbilitiesVendor ManagementProject ManagementTechnical AcumenBusiness Acumen
Industry Keywords
Biopharmaceutical IndustryGMPGDPICH GuidelinesClinical Supply ReadinessOutsourced ManufacturingCDMO ManagementRegulated EnvironmentClinical TimelinesOperational Excellence
About the role
Key responsibilities & impact- Lead and manage outsourced manufacturing operations supporting clinical and future commercial programs
- Lead the strategy, selection, and management of CDMOs for drug substance and drug product manufacturing
- Serve as the primary operational interface between Praxis and external manufacturing partners
- Oversee technology transfer, process scale-up, validation, and clinical supply readiness
- Establish and maintain Quality and Technical Agreements with manufacturing partners
- Manage end-to-end supply chain activities, including raw materials procurement, production planning, logistics, inventory management, and distribution
- Lead supplier qualification, monitoring, and performance evaluations
- Negotiate supplier and CMO contracts and pricing agreements
- Collaborate with Process Chemistry, Formulation, Analytical, Quality, and Regulatory teams on CMC deliverables
- Support CMC development strategies aligned with clinical timelines, regulatory expectations, and company objectives
- Manage manufacturing planning, scheduling, and inventory to ensure uninterrupted clinical supply
- Ensure outsourced manufacturing complies with GMP and regulatory standards
- Implement KPIs and governance mechanisms to monitor and improve CDMO performance
- Identify and mitigate technical and operational risks across the external supply network
- Drive operational excellence and process improvements to enhance efficiency and compliance
Requirements
What you’ll need- Advanced degree preferred in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; bachelor’s degree with extensive relevant experience considered
- 15+ years of progressive CMC or manufacturing experience within the biopharmaceutical industry
- At least 8 years managing external manufacturing relationships
- Experience managing global CMC supply chains for commercial products in a regulated environment
- Strong understanding of GMP, GDP, and ICH guidelines and their application in a commercial setting
- Experience overseeing both drug substance and drug product manufacturing at clinical and/or commercial scale
- Excellent negotiation and vendor management abilities, including experience working with CMOs and managing third-party relationships
- Ability to manage complex projects and external relationships with technical and business acumen
- Ability to navigate complex regulatory and compliance requirements
- Flexibility and willingness to travel as needed
Benefits
Comp & perks- 99% of the premium paid for medical, dental and vision plans
- Company-paid life insurance
- AD&D benefits
- Disability benefits
- Voluntary plans to personalize coverage
- Dollar-for-dollar 401(k) match up to 6% on eligible contributions
- Long-term stock incentives
- ESPP
- Discretionary quarterly bonus
- Extremely flexible wellness benefit
- Generous PTO
- Paid holidays
- Company-wide shutdowns