Position Summary
The Director, Process Development will lead development, characterization, technology transfer, and commercialization activities for autologous cell therapy manufacturing processes. This role is responsible for ensuring manufacturing processes are robust, scalable, well-characterized, and positioned to support regulatory submissions, process validation, and commercial manufacturing.
The Director will provide technical leadership across process development, process characterization, control strategy development, comparability assessments, and process validation planning. Working closely with Manufacturing, Quality, Regulatory Affairs, and Analytical Development, this individual will ensure processes are scientifically sound, operationally feasible, and capable of meeting clinical and commercial performance requirements.
This position serves as a key technical leader within Technical Operations and plays a critical role in advancing programs from late-stage development through licensure and commercialization.
Key Responsibilities
Process Development
- 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.
Process Characterization and Control Strategy
- 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 QC 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.
Process Validation Planning and Readiness
- Lead 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
- Validation support reports for regulatory submissions
- Ensure process characterization studies adequately support process validation and PPQ execution.
- Partner closely to transition validated process knowledge into manufacturing execution.
- Provide technical oversight and subject matter expertise during PPQ planning and execution activities.
Technology Transfer and Commercialization
- Lead 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.
Cross-Functional Leadership
- Collaborate effectively with:
- Manufacturing
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Analytical Development
- Supply Chain
- 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 forums.
People Leadership
- 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.
Qualifications
- PhD, MS, 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
- Comparability assessments
- GMP manufacturing
- Regulatory expectations for biologics and cell therapies
- Statistical design and controls (e.g., DOE, statistical process control, etc)
- Experience supporting PPQ preparation and commercial process implementation preferred.
- Prior experience with autologous cell therapy manufacturing and biologics commercialization strongly preferred.