Director Of Process Development

This role ensures that manufacturing processes are robust, scalable, well-characterized, and capable of supporting regulatory submissions, process validation, and commercial manufacturing for autologous cell therapy programs.

Responsibilities

• Lead process development activities supporting clinical and commercial cell therapy programs.
• Develop and execute strategies to improve process robustness, consistency, scalability, and manufacturability.
• Generate process understanding through process characterization studies, manufacturing data analysis, and development investigations.
• Establish process design space, operating ranges, and process performance requirements.
• Drive continuous improvement initiatives to enhance product quality, process capability, and manufacturing efficiency.
• Lead control strategy development through identification and assessment of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Key Process Parameters (KPPs).
• Design and oversee process characterization studies required to support commercial manufacturing and regulatory filings.
• Partner with Analytical Development and Quality Control to establish analytical approaches supporting process understanding.
• Develop and maintain process control strategies that ensure product quality and manufacturing consistency.
• Author and review technical reports and development documentation supporting regulatory submissions.
• Lead the development of the scientific framework supporting process validation.
• Define validation approaches, acceptance criteria, sampling strategies, and process performance expectations.
• Author or oversee development of Process Validation Master Plans, Process Characterization Reports, Process Risk Assessments, Control Strategy Documents, Continued Process Verification plans, and validation support reports for regulatory submissions.
• Ensure process characterization studies adequately support process validation and PPQ execution.
• Provide technical oversight and subject matter expertise during PPQ planning and execution activities.
• Lead the transfer of process knowledge, technical documentation, and control strategies to Manufacturing.
• Support manufacturing readiness activities for new facilities, suites, and process introductions.
• Ensure successful implementation of process changes and lifecycle improvements.
• Participate in commercial launch planning and post-approval process management.
• Collaborate effectively with Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Analytical Development, Supply Chain, and Engineering.
• Provide technical support for deviations, investigations, CAPAs, change controls, and regulatory inspections.
• Contribute to regulatory submissions and health authority responses.
• Present technical recommendations and program updates to leadership teams and governance bodies.
• Lead and develop a team of process development scientists and engineers.
• Establish goals, priorities, and development plans for direct reports.
• Promote scientific excellence, accountability, collaboration, and continuous improvement.
• Support recruitment and development of technical talent to meet organizational growth objectives.

Requirements

• PhD or equivalent advanced degree in Chemical Engineering, Biomedical Engineering, Biological Sciences, Pharmaceutical Sciences, or related discipline.
• 10+ years of biopharmaceutical, biologics, or cell therapy experience, including leadership responsibilities.
• Demonstrated experience in process development and technology transfer within a GMP-regulated environment.
• Experience supporting late-stage development, commercialization, or BLA-enabling activities.
• Strong understanding of process characterization, control strategy development, process validation principles, and regulatory expectations for biologics and cell therapies.
• Experience with statistical design and controls (e.g., DOE, statistical process control).
• Previous people management experience is essential.
• Willingness to work hands-on with the team.

Skills

• Cell therapy and CAR-T process development
• Process characterization and technology transfer
• Process validation and risk assessment
• GMP compliance and control strategy development
• Design of Experiments (DOE) and statistical design

Benefits

• Health, dental, and vision insurance
• Life and AD&D coverage
• 401(k) retirement plan
• Employee stock purchase plan

Pay

The pay range for this position is $215,000 - $275,000 per year. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, and internal equity.

Schedule

This is a permanent, fully onsite position in Frederick, MD. The work environment initially requires onsite presence five days a week, with potential to transition to a hybrid model offering 1-2 days of flexibility.