Associate Director, Process Development, Cell Therapy

Position Summary

The Associate DirectorLate-StageCell TherapyProcessDevelopmentwill provide scientific and technical leadership for the development characterization and transfer of manufacturing processes for cell therapy products. This roleis responsible forleading a team of scientists and engineers supporting process development activities from clinical development through commercialization including BLA and global regulatory submissions. The successful candidate will partner cross-functionally with Manufacturing Quality Regulatory Affairs Analytical Development and CMC teams to ensure robust compliant and scalable manufacturing processes.

Key Responsibilities

Technical Leadership

• Lead the late-stage process development for cell therapies within the Process Engineering function managing multiple development projects

• Direct and guide engineers/scientists to deliver high-quality technical documentation for the study design laboratory execution and report authoring activities

• Perform risk assessment data analysiswritetechnical reports and present outcome of the studies to crossfunctional teams and governance forums

• Conduct batch record review deviation assessment and data trending to ensure robustness of cell therapy manufacturing processes

• Apply AIenabled tools and digital analytics to accelerate data review trend analysis batch record evaluation and process understanding

Team Leadership and Management

• Build develop and manage a high-performing team of process development scientists and engineers

• Establish project priorities resource allocation and departmental objectives

• Foster a collaborative and innovation-driven culture

PPQ&TechnologyTransfer

• SupportPPQactivitiesincluding but not limited toprotocol authoring batch recordauthoringandplanning

• Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batchrecords

Lifecycle Management

• Lead lifecycle management activities for commercial cell therapy products including process monitoring continuous improvement post-approval changes comparability assessments and regulatory commitments.

• Partner with Manufacturing Quality Regulatory Affairs and Technical Operations to implement process improvementsmaintainprocess control and support ongoing commercial readiness.

Manufacturing Support & Scientific Deviation Management

• Serve as the Process Development and Engineering SME for manufacturing operations providing scientific support for deviations investigations atypical events and process-related issues.

• Lead root cause analyses impact assessments and CAPA development using data-driven and risk-based approaches to ensure product quality compliance and uninterrupted manufacturing operations.

Regulatory Support

• Contributesto authoring and reviewing CMC documentation including cell therapy process descriptions characterization summaries PPQ protocols and reports and control strategy elements.

• Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing.

CrossFunctional Collaboration

• Work closely with analytical sciences quality regulatory and manufacturing teams to ensure endtoend process alignment.

• Represent cell therapy characterization activities in technical meetings reviews and governance discussions.

Required Qualifications

• Ph.D. in Chemical Engineering Biochemical Engineering Biological Sciences Biotechnology Pharmaceutical Sciences or related discipline with6 years of industry experience; or M.S. with 10 years of relevant experience; or B.S. with 12 years of relevant experience.

• Strong technicalexpertiseincell therapyprocess developmentGMP operations and latestage / commercial readiness.

• Experience with latestage development and PPQ for cell therapy processes.

• Demonstratedproficiencyin applying AI tools and digital solutions to data analysis documentation and workflow automation.

• Strong technical writing data analysis and problemsolving skills.

Preferred Qualifications

• Experience with commercial-stage cell therapyorbiologicsproducts.

• Experience supporting PPQ process validation and post-approval changes.

• Familiarity with global regulatory requirements and lifecycle management strategies.

• Experience designing and executing DOE and multivariate data analysis for cell therapy processes.

Key Competencies

• Strong teammanagement and talent development experience

• Excellent crossfunctional communication and collaboration.

• Ability tooperateeffectively in fastpaced latestage development environments.

• Scientific curiosity ownership mindset and willingness to support manufacturing operations.

The annual base pay for this position ranges from $138K to $207K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.

# Hybrid # Cell Therapy