MSAT, Global Sr Director


The Global Sr. Director, MS&T provides strategic and operational leadership for Manufacturing Science and Technology across a multi-site biomanufacturing network. This role spearheads end-to-end technology transfer, process scale-up, validation (PPQ), and lifecycle management for bulk drug substance (BDS) and drug product (DP) programs under strict FDA and EU cGMP regulations. Serving as the primary technical interface for external clients and cross-functional teams, the Global Sr. Director champions operational excellence, risk management, and the buildout of global MSAT capabilities to support expanding commercial operations. Plans and Oversees technology transfer strategy and activities to support products and processes at highest level of GMP compliance per FDA and EU regulations. Provides technical oversight to biomanufacturing operations of drug substance and drug product over multiple sites. Creates, Revises, reviews, and approves standard operation procedures (SOP’s), work instructions (WIS), specifications (SPC), protocols (PRO), reports (RPT), forms (FRM) including production/batch records in support of bioprocessing unit operations associated with biomanufacturing campaigns. Plans staffing and materials resources to execute manufacturing unit operations efficiently. Hires, trains, develops, evaluates, and provides motivational leadership to staff in achieving productivity targets and timely delivery of products. Works collaboratively with company subject matter experts in ensuring unit compliance to safety (OSHA), cGMP regulations, quality standards, maintenance and monitoring of appropriate Engineering standards and controls within the manufacturing environment. Establishes continuous quality improvement processes for GMP biomanufacturing activities. Documents manufacturing process deviations, conducts impact analyses, risk assessments and root cause analyses and drafts or approves corrective and preventive action plans. Performs timely closure of deviation records. Management of Change Controls and other mechanisms in support of manufacturing operations. Routinely monitors, tracks, evaluates, and reports unit performance data to support project management/communication and deliverables such as campaign summary reports. Coordinates MSAT activities across manufacturing sites to promote consistent technical standards, knowledge transfer, and application of best practices. Provides support and representation of technology transfer and manufacturing operations in pre-approval inspections and internal/external audits. Provides technical leadership for process scale-up, process characterization, engineering runs, process validation/PPQ, continued process verification, manufacturing readiness, and lifecycle management activities as appropriate to the program phase. Serves as a senior technical interface with clients and cross-functional teams and supports site-to-site technology transfers, process changes, comparability assessments, technical risk mitigation, and proposal writing. Other duties as assigned. Team Leadership & Organizational Culture Shapes and champions the culture of the global MSAT organization, serving as a key leader in growing the function and its capabilities in support of network expansion. Owns delivery coordination of all MSAT-led programs, including work allocation, deliverable quality, performance expectations, and integration with internal teams. Establishes clear roles, responsibilities, objectives, and development priorities for team members; allocates resources across the MSAT project portfolio based on technical complexity, business priority, capacity, and project timing. Provides coaching and feedback to team members and helps develop the organization’s future MSAT capabilities. Drug Substance Scope Manages projects related to bulk drug substance (BDS) technology transfer, process changes, site onboarding, and manufacturing readiness across the network. Coordinates MSAT technical inputs for investigations, process improvements, and lifecycle initiatives affecting drug substance manufacturing. Ensures alignment between the client and network sites on execution, approved process understanding, and control strategy. End-to-End CMC Project Support Leads or supports client projects spanning drug substance (DS), drug product (DP), and supply chain readiness as needed, serving as the key leader ensuring successful client technology transfers into the facility. Coordinates handoffs and dependencies across DS, DP, Quality, Regulatory CMC, and Supply Chain teams. Maintains visibility into cross-functional risks and mitigation plans impacting overall project timelines. Risk, Issue & Change Management Identifies, tracks, and escalates technical and execution risks related to manufacturing projects. Supports management of project-related changes, including scope, timelines, and technical dependencies. Ensures issues are documented, communicated, and resolved through appropriate governance channels. Communication & Governance Prepares and delivers clear project updates to MSAT leadership and cross-functional teams. Supports project governance forums, decision tracking, and documentation. Ensures project execution aligns with GMP requirements and internal MSAT standards. Educational Qualifications Required: BS Degree in Scientific discipline, Biotechnology, Biochemistry, or Engineering Preferred education: MS Degree in Scientific Discipline, Biotechnology or Engineering Additional Qualifications 10-15 years of experience in cGMP environment Direct experience in cGMP manufacturing operations 6-8 years leadership experience, including performance management, growth and development, and resource planning during production ramp-up Demonstrated technical expertise in tech transfer in a GMP and regulated environment Familiarity with AAV gene therapy, commercial manufacturing, PPQ execution, and client-facing leadership Physical Requirements Physical demands: (check one) ☐ sedentary (< 10 lbs.) ☐ light work (< 20 lbs.) XX medium work (< 50 lbs.) ☐ heavy work (< 100 lbs.) ☐ very heavy work (> 100 lbs.) Physical activity: (check all that apply) ☐ repetitive motion ☐ balancing ☐ stooping ☐ lifting ☐ climbing ☐ kneeling/crouching ☐ crawling ☐ reaching XX standing XX typing/grasping XX walking ☐ pushing/pulling ☐ hearing Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.) Working conditions (indoor/outdoor, noise levels, hazards, working quarters) Travel Requirements (5-10%) Supervisor Responsibilities This position requires previous supervisory experience.

The Global Sr. Director, MS&T provides strategic and operational leadership for Manufacturing Science and Technology across a multi-site biomanufacturing network. This role spearheads end-to-end technology transfer, process scale-up, validation (PPQ), and lifecycle management for bulk drug substance (BDS) and drug product (DP) programs under strict FDA and EU cGMP regulations. Serving as the primary technical interface for external clients and cross-functional teams, the Global Sr. Director champions operational excellence, risk management, and the buildout of global MSAT capabilities to support expanding commercial operations.

Plans and Oversees technology transfer strategy and activities to support products and processes at highest level of GMP compliance per FDA and EU regulations. Provides technical oversight to biomanufacturing operations of drug substance and drug product over multiple sites.
Creates, Revises, reviews, and approves standard operation procedures (SOP’s), work instructions (WIS), specifications (SPC), protocols (PRO), reports (RPT), forms (FRM) including production/batch records in support of bioprocessing unit operations associated with biomanufacturing campaigns.
Plans staffing and materials resources to execute manufacturing unit operations efficiently.
Hires, trains, develops, evaluates, and provides motivational leadership to staff in achieving productivity targets and timely delivery of products.
Works collaboratively with company subject matter experts in ensuring unit compliance to safety (OSHA), cGMP regulations, quality standards, maintenance and monitoring of appropriate Engineering standards and controls within the manufacturing environment.
Establishes continuous quality improvement processes for GMP biomanufacturing activities. Documents manufacturing process deviations, conducts impact analyses, risk assessments and root cause analyses and drafts or approves corrective and preventive action plans. Performs timely closure of deviation records. Management of Change Controls and other mechanisms in support of manufacturing operations.
Routinely monitors, tracks, evaluates, and reports unit performance data to support project management/communication and deliverables such as campaign summary reports.
Coordinates MSAT activities across manufacturing sites to promote consistent technical standards, knowledge transfer, and application of best practices.
Provides support and representation of technology transfer and manufacturing operations in pre-approval inspections and internal/external audits.
Provides technical leadership for process scale-up, process characterization, engineering runs, process validation/PPQ, continued process verification, manufacturing readiness, and lifecycle management activities as appropriate to the program phase.
Serves as a senior technical interface with clients and cross-functional teams and supports site-to-site technology transfers, process changes, comparability assessments, technical risk mitigation, and proposal writing.
Other duties as assigned.

Team Leadership & Organizational Culture

Shapes and champions the culture of the global MSAT organization, serving as a key leader in growing the function and its capabilities in support of network expansion.
Owns delivery coordination of all MSAT-led programs, including work allocation, deliverable quality, performance expectations, and integration with internal teams.
Establishes clear roles, responsibilities, objectives, and development priorities for team members; allocates resources across the MSAT project portfolio based on technical complexity, business priority, capacity, and project timing.
Provides coaching and feedback to team members and helps develop the organization’s future MSAT capabilities.

Drug Substance Scope

Manages projects related to bulk drug substance (BDS) technology transfer, process changes, site onboarding, and manufacturing readiness across the network.
Coordinates MSAT technical inputs for investigations, process improvements, and lifecycle initiatives affecting drug substance manufacturing.
Ensures alignment between the client and network sites on execution, approved process understanding, and control strategy.

End-to-End CMC Project Support

Leads or supports client projects spanning drug substance (DS), drug product (DP), and supply chain readiness as needed, serving as the key leader ensuring successful client technology transfers into the facility.
Coordinates handoffs and dependencies across DS, DP, Quality, Regulatory CMC, and Supply Chain teams.
Maintains visibility into cross-functional risks and mitigation plans impacting overall project timelines.

Risk, Issue & Change Management

Identifies, tracks, and escalates technical and execution risks related to manufacturing projects.
Supports management of project-related changes, including scope, timelines, and technical dependencies.
Ensures issues are documented, communicated, and resolved through appropriate governance channels.

Communication & Governance

Prepares and delivers clear project updates to MSAT leadership and cross-functional teams.
Supports project governance forums, decision tracking, and documentation.
Ensures project execution aligns with GMP requirements and internal MSAT standards.

Educational Qualifications

Required: BS Degree in Scientific discipline, Biotechnology, Biochemistry, or Engineering
Preferred education: MS Degree in Scientific Discipline, Biotechnology or Engineering

Additional Qualifications

10-15 years of experience in cGMP environment
Direct experience in cGMP manufacturing operations
6-8 years leadership experience, including performance management, growth and development, and resource planning during production ramp-up
Demonstrated technical expertise in tech transfer in a GMP and regulated environment
Familiarity with AAV gene therapy, commercial manufacturing, PPQ execution, and client-facing leadership

Physical Requirements

Physical demands: (check one)

☐ sedentary (< 10 lbs.) ☐ light work (< 20 lbs.)

XX medium work (< 50 lbs.) ☐ heavy work (< 100 lbs.)

☐ very heavy work (> 100 lbs.)

Physical activity: (check all that apply)

☐ repetitive motion ☐ balancing ☐ stooping ☐ lifting

☐ climbing ☐ kneeling/crouching ☐ crawling ☐ reaching

XX standing XX typing/grasping XX walking ☐ pushing/pulling

☐ hearing

Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.)
Working conditions (indoor/outdoor, noise levels, hazards, working quarters)

Travel Requirements (5-10%)

Supervisor Responsibilities

This position requires previous supervisory experience.