Process Development Jobs in Gaithersburg, MD (NOW HIRING)

The Director of Process Development will lead the development, characterization, technology transfer, and commercialization activities for autologous cell therapy manufacturing processes. This role ensures that manufacturing processes are robust, scalable, well-characterized, and capable of supporting 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. They will work closely with Manufacturing, Quality, Regulatory Affairs, and Analytical Development to ensure processes meet 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.

• 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.

• Experience with cell therapy, CAR-T, process development, characterization, technology transfer, process validation, risk assessment, GMP, control strategy development, DOE, statistical design, and design of experiments.
• 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.
• Experience supporting PPQ preparation and commercial process implementation is preferred.
• Prior experience with autologous cell therapy manufacturing and biologics commercialization is strongly preferred.

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. The role necessitates someone who is local and available for onsite work.

This is a Permanent position based out of Frederick, MD.

The pay range for this position is $215000.00 - $275000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

health, dental, and vision insurance, life and AD&D coverage, a 401(k) retirement plan, an employee stock purchase plan,

This is a fully onsite position in Frederick,MD.

This position is anticipated to close on Sep 1, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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