Associate Director – MSAT

Uwi (AI Recruiter by HeroHunt.ai)

Associate Director leading process readiness strategy for growth investment projects in bioconjugate drug manufacturing. Overseeing all aspects from design to operational readiness with a focus on GMP compliance.

Posted 7/22/2026full-timeRemote • Maryland • 🇺🇸 United StatesSenior💰 $174,600 - $203,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in MSAT process ownership, including technology transfer, process validation, and operational readiness within a regulated manufacturing environment. Proven ability to lead cross-functional teams and manage complex projects while ensuring compliance with GMP and regulatory standards.

Highest-signal resume keywords

MSAT Process OwnershipGMP Manufacturing OperationsTechnology Transfer StrategiesProcess ValidationCross-Functional Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process Scale-UpLifecycle ManagementContinuous ImprovementOperational ReadinessRisk Assessment and MitigationBioconjugate Drug Substance ManufacturingCommissioning and QualificationManufacturing Expansion SupportData Integrity RequirementsLean Principles

Soft Skills

Excellent CommunicationPresentation SkillsCollaborationAccountabilityInfluencing Stakeholders

Tools & Technologies

Automation SystemsDigital Manufacturing TechnologiesSix Sigma Methodologies

Industry Keywords

Pharmaceutical ManufacturingBiotechnologyRegulatory RequirementsQuality SystemsOperational Excellence

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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).