Director, Commercial Manufacturing Operations
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Job Description
Director leading CDMO manufacturing operations for Praxis, a biopharmaceutical company developing CNS therapies. Ensuring reliable GMP supply, quality, and continuous improvement across external partners.
Responsibilities:
- Serve as the operational owner for commercial manufacturing performance at assigned CDMO partners
- Ensure reliable execution of production schedules, supply commitments, and operational readiness
- Lead a cross-functional Virtual Manufacturing Team across Manufacturing, MSAT, Quality, Supply Chain, Procurement, Regulatory, and Analytical Development
- Develop operational visibility and proactively identify staffing, equipment, material, scheduling, and compliance risks
- Establish performance metrics and improve right-first-time performance, schedule adherence, cycle times, yields, and manufacturing reliability
- Partner with Quality on deviations, investigations, CAPAs, change controls, and audit observations while maintaining GMP compliance
- Lead operational response during batch-at-risk events, supply disruptions, and significant operational escalations
- Implement continuous-improvement initiatives to improve performance, reduce cost, increase capacity, and strengthen CDMO capabilities
- Serve as Praxis’s virtual plant manager for commercial manufacturing of an assigned product
Requirements:
- Bachelor’s degree in engineering, pharmaceutical sciences, chemistry or a related discipline; advanced degree preferred
- 15+ years of pharmaceutical or biotechnology manufacturing experience, including significant leadership experience supporting commercial GMP operations
- Demonstrated experience leading manufacturing operations at a commercial manufacturing site
- Significant experience managing external manufacturing partners (CDMOs) supporting commercial products
- Strong knowledge of commercial manufacturing operations, GMP regulations, quality systems, deviation management, CAPA processes, and continuous improvement methodologies
- Ability to influence cross-functional teams and external partners without direct reporting authority
- Excellent communication skills with the ability to translate operational complexity into clear business decisions for senior leadership
- Willingness and flexibility to travel approximately 40–60%, including international travel as needed
- Comfort with screen work, basic hand coordination, sustained focus, and occasional movement
Benefits:
- 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
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