Director, Commercial Manufacturing Operations

Job not on LinkedIn

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $214k - $234k / year

⏰ Full Time

🔴 Lead

⚙️ Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 20%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 1 day.
• Jobs at this company usually fill in 49 days.
• 140 open roles for a team of 51.

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Serve as the operational owner for commercial manufacturing performance at assigned CDMO partners, ensuring 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 into manufacturing performance and proactively identify staffing, equipment, material, scheduling, and compliance risks • Establish performance metrics and partner with CDMO leadership to 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

🎯 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 (Plant Manager, Operations Leader, or equivalent operational leadership role) • 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 • Demonstrated 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 • Regular use of a computer, devices or other office equipment; clear communication; occasional movement; comfort with screen work, basic hand coordination, and sustained focus

🏖️ 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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