Scientist-Cell Therapy MSAT/Process Development

Job Title: Scientist Cell Therapy MSAT / Process Development Hybrid Flexibility

Job Description

This contract Scientist role supports Cell Therapy Manufacturing Science & Technology (MSAT) and Process Development (PD) across the full manufacturing process lifecycle. You will play a key technical role from technology transfer and scale-up through ongoing commercial manufacturing, helping to maintain process control, drive continuous improvement, support regulatory compliance, and resolve manufacturing issues. The position is highly hands-on and requires independence in experimental design, execution, data analysis, interpretation, and technical report writing. Experience with late-stage development activities such as process characterization, process validation, PPQ readiness, or commercial process development is highly desirable. This is an opportunity to contribute to leading-edge autologous cell therapy and mRNA technologies at a pivotal time, with integrated manufacturing and the ability to influence local processes and learn in a dynamic environment.

Responsibilities

• Support technology transfer and scale-up of cell therapy manufacturing processes from development into manufacturing, including ensuring process readiness, facilitating knowledge transfer, and providing technical troubleshooting.
• Monitor and analyze manufacturing data to assess process performance, identify trends, and support continued process verification (CPV), process control, and timely identification of emerging issues.
• Provide technical support for manufacturing deviations and quality-event investigations, including performing root cause analysis, defining scientifically justified corrective and preventive actions (CAPAs), and assessing the effectiveness of implemented actions.
• Identify, evaluate, and support implementation of process improvements that strengthen process robustness, product quality, yield, and manufacturing efficiency while maintaining appropriate process control.
• Prepare and review technical protocols, reports, and supporting documentation for technology transfer, ongoing manufacturing, regulatory submissions, audits, and inspections in collaboration with Quality and other technical functions.
• Independently design and execute hands-on cell therapy studies to address process development objectives and manufacturing questions, providing as-needed PD support.
• Apply Design of Experiments (DOE) and other structured approaches to evaluate process parameters, operating ranges, and their impact on process performance and product quality.
• Analyze and interpret study data, troubleshoot experimental issues, and recommend follow-up studies to support process development, optimization, and late-stage development deliverables.
• Prepare clear protocols and technical reports for PD studies, maintain accurate and traceable experimental records, and communicate findings and recommendations to cross-functional technical teams.
• Collaborate with PD, MSAT, manufacturing, and Quality teams to translate study outcomes into process knowledge, control strategies, and technology transfer packages that support late-stage development and commercialization.
• Contribute to risk assessments related to manufacturing processes, investigations, and process changes, ensuring that process control strategies appropriately link parameters and operating ranges to product quality.
• Support aseptic process validation activities, PPQ readiness, and PPQ runs, including data analysis and report writing for validation and commercial process development.

Essential Skills

• Bachelors degree with 6 years, Masters degree with 4 years, or PhD with 2 years of experience in biological sciences, bioengineering, chemical engineering, biotechnology, or a related discipline.
• Industry experience in cell therapy or cell culture MSAT, manufacturing support, or process development, with direct knowledge of technology transfer and ongoing manufacturing operations.
• Proven ability to independently design and execute hands-on studies for manufacturing troubleshooting and process development support.
• Strong statistical data analysis skills to assess process trends, evaluate process performance, and support continued process verification (CPV).
• Demonstrated scientific problem-solving skills, including root cause analysis and development of scientifically justified corrective and preventive actions (CAPAs).
• Advanced technical writing skills for authoring and reviewing protocols, technical reports, and process documentation, ensuring accurate records and data traceability.
• Solid understanding of GMP principles and regulatory compliance requirements in a manufacturing environment.
• Ability to work independently, manage priorities effectively, and collaborate closely with manufacturing, technical, and Quality teams.
• Hands-on experience with cell therapy processes, CAR-T or related modalities, and manufacturing science and technology (MSAT) activities.
• Experience with process control, process improvement, process characterization, and process validation in a regulated environment.
• Competence in investigations and risk assessment related to manufacturing deviations and quality events.

Additional Skills & Qualifications

• Experience with cell therapy technology transfer, scale-up, and GMP manufacturing, including late-stage development or commercialization.
• Expereince in continued CPV programs, manufacturing investigations, CAPAs, and implementation of process improvements to enhance robustness and efficiency.
• Experience with process characterization, validation, PPQ readiness, PPQ runs, and development of control strategies linking process parameters and operating ranges to product quality.
• Proficiency with Design of Experiments (DOE) methodologies and tools such as JMP or equivalent statistical software.
• Experience preparing technical documentation to support regulatory submissions, audits, and inspections.
• Familiarity with autologous cell therapy and mRNA technologies and their specific manufacturing and development considerations.
• Strong report writing capabilities for validation, PPQ, and commercial process development activities.
• Motivation to work in a builder environment with leading-edge technology and integrated manufacturing, contributing to key milestones and continuous learning.

Work Environment

This role is primarily onsite, with a standard schedule of five days per week from approximately 8:00 a.m. to 5:00 p.m. There may be occasional weekend work on an on-call, rotating basis, which would typically be performed remotely. The position offers some hybrid flexibility depending on business needs. You will work in a GMP-regulated manufacturing and laboratory environment focused on autologous cell therapy and mRNA technologies, collaborating closely with cross-functional technical, manufacturing, and Quality teams. The setting emphasizes integrated manufacturing, data-driven decision making, and a culture of continuous improvement and learning. Appropriate professional attire and adherence to facility gowning and safety requirements are expected in laboratory and manufacturing areas.

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

The pay range for this position is $55.00 - $75.00/hr.

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.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

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

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

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 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.

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 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.