Director Of Process Development Scientist

Actalent; Frederick (MD); In loco; USD 215.000 - 275.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Dental insurance

Vision insurance

Life and AD&D coverage

401(k) retirement plan

Employee stock purchase plan

Descrizione del lavoro

Actalent in Frederick, MD seeks a Director of Process Development Scientist to lead development, characterization, technology transfer, and commercialization of autologous cell therapy processes. You will ensure robust, scalable processes for regulatory submissions, validation, and manufacturing.

The role provides technical leadership across process development, validation planning, comparability assessments, and regulatory support, partnering with Manufacturing, Quality, Regulatory Affairs,

Competenze

• PhD or equivalent advanced degree in Chemical Engineering, Biomedical Engineering, Biological Sciences, Pharmaceutical Sciences, or related field.
• 10+ years of biopharmaceutical or cell therapy experience with leadership responsibilities.
• Experience in GMP-regulated process development and technology transfer.

Mansioni

• Lead process development activities supporting clinical and commercial programs.
• Develop strategies to improve process robustness, consistency, scalability and manufacturability.
• Generate process understanding through characterization studies and data analysis.
• Establish process design space, operating ranges and performance requirements.
• Lead transfer of processes to manufacturing and support PPQ activities.
• Collaborate with QA, Regulatory, Analytical Development to ensure compliance.

Conoscenze

Process development

Technology transfer

DOE

Statistical design

GMP

Validation principles

Leadership

Biopharma/cell therapy

Formazione

PhD or equivalent in Chemical Engineering / Biomedical Engineering / Biological Sciences / Pharmaceutical Sciences / related field

Descrizione del lavoro

Job Title: Director of Process Development Scientist

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.

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.

Essential Skills

• 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).

Additional Skills & Qualifications

• 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.

Work Environment

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.

Job Type & Location

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

Pay And Benefits

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 insurance
• dental insurance
• vision insurance
• life and AD&D coverage
• 401(k) retirement plan
• employee stock purchase plan

Application Deadline

This position is anticipated to close on Nov 16, 2026.

Workplace Type

This is a fully onsite position in Frederick,MD.

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 20000 consultants and 5000 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.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.