Associate Director – MSAT

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🔥 0 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $174.6k - $203.7k / year

⏰ Full Time

🟠 Senior

👔 Director

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Uwi (AI Recruiter by HeroHunt.ai)

WebsiteLinkedInAll Job Openings

11 - 50 employees

👥 HR Tech

🤖 Artificial Intelligence

☁️ SaaS

HR Tech • Artificial Intelligence • SaaS

Uwi (AI Recruiter by HeroHunt. ai) is an innovative recruitment platform that automates the full cycle of talent acquisition. It is powered by advanced AI technologies such as RecruitGPT, which enables it to conduct AI-driven candidate searches and screenings. Uwi can autonomously reach out to potential candidates and personalize outreach using prompt-based AI. Its platform integrates with various data sources to find candidates globally, offering services such as LinkedIn profile searches and outreach automation to provide efficient recruitment solutions with minimal effort from users. This service aims to reduce the time and costs associated with hiring by leveraging AI's capabilities to find the best talent worldwide.

📋 Description

• Serve as the MSAT process owner for an assigned U.S. growth investment project, ensuring successful process implementation and operational readiness • Develop and execute the process robustness and readiness roadmap, including coordination with internal and external stakeholders throughout the project lifecycle • Lead process-related commissioning, qualification, validation readiness, start-up activities, and operational handover to the receiving manufacturing organization • Provide end-to-end lifecycle management for manufacturing processes, including process introduction, technology transfer, validation, process performance monitoring, continuous improvement, and regulatory support activities • Partner with Engineering, Manufacturing, Quality, Automation, and EHS teams to ensure process requirements, user needs, automation strategies, equipment design, and GMP expectations are incorporated into project execution • Ensure manufacturing operations are aligned with GMP requirements, quality systems, safety standards, and corporate expectations to support successful inspections and long-term operational excellence • Lead technology transfer activities and product introduction planning in partnership with customers and internal stakeholders, ensuring readiness for clinical and commercial manufacturing • Identify, assess, and mitigate operational, technical, and project-related risks associated with personnel, training, equipment, process robustness, and facility readiness • Build, develop, and lead a high-performing operations and MSAT team, fostering a culture of accountability, collaboration, continuous improvement, and operational excellence • Provide strategic updates, readiness assessments, and risk escalations to senior leadership and project governance teams

🎯 Requirements

• Master’s degree in engineering, Biotechnology, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related discipline preferred; Bachelor's degree with significant relevant experience will also be considered • 10+ years of experience in pharmaceutical or biotechnology manufacturing, including leadership experience within MSAT, Technical Operations, Process Engineering, or Manufacturing Operations • Demonstrated experience supporting or leading bioconjugate drug substance manufacturing processes, including process scale-up, technology transfer, process validation, and commercial manufacturing support • Strong understanding of GMP manufacturing operations, regulatory requirements, technology transfer, commissioning, qualification, validation, and operational readiness activities • Experience supporting major capital investment projects, facility start-ups, manufacturing expansions, or large-scale operational growth initiatives • Proven ability to lead cross-functional teams and influence stakeholders across Engineering, Manufacturing, Quality, Automation, Supply Chain, EHS, HR, Finance, and Project Management functions • Experience developing and executing technology transfer strategies to support successful process implementation and commercial manufacturing readiness • Strong understanding of process performance monitoring, lifecycle management, continuous improvement, and operational excellence principles within a regulated manufacturing environment • Demonstrated ability to identify, assess, and mitigate technical, operational, compliance, and project execution risks • Excellent communication and presentation skills, with the ability to effectively engage senior leadership, governance committees, customers, and external partners • Experience building organizational capability, developing technical talent, and preparing teams for successful operational handover and long-term manufacturing success • Knowledge of Lean principles, Six Sigma methodologies, automation systems, digital manufacturing technologies, and data integrity requirements preferred • Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve • Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives.

🏖️ Benefits

• Performance-related bonus. • Medical, dental and vision insurance. • 401(k) matching plan. • Life insurance, as well as short-term and long-term disability insurance. • Employee assistance programs. • Paid time off (PTO).