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Cell Therapy Process Development information

What are the key skills and qualifications needed to thrive as a cell therapy process development professional?

To thrive in Cell Therapy Process Development, you need a solid background in cell biology, biotechnology, or a related field, often supported by a relevant degree and experience with cell culture techniques. Familiarity with bioprocessing equipment, Good Manufacturing Practice (GMP) regulations, and analytical tools such as flow cytometry and PCR is typically required. Strong problem-solving skills, attention to detail, and effective teamwork enhance performance in this collaborative and innovative environment. These competencies ensure the safe and efficient development of cell therapies, meeting rigorous quality standards and advancing clinical applications.

What are some typical challenges faced by professionals in cell therapy process development, and how are they addressed?

Professionals in Cell Therapy Process Development often encounter challenges such as scaling up production processes from laboratory to clinical or commercial scale while maintaining product quality and consistency. Additional hurdles include adhering to strict regulatory requirements and managing complex collaborations across cross-functional teams, like quality assurance, regulatory affairs, and manufacturing. These challenges are typically addressed through rigorous process optimization, thorough documentation, and ongoing communication with stakeholders to ensure that all aspects of the process meet industry standards and regulatory expectations.

What is the difference between Cell Therapy Process Development vs Cell Therapy Manufacturing Specialist?

AspectCell Therapy Process DevelopmentCell Therapy Manufacturing Specialist
CredentialsTypically requires a degree in biology, biochemistry, or biomedical engineering; certifications in GMP or cell therapy are commonSimilar credentials; often holds degrees in related fields and GMP certifications
Work EnvironmentResearch labs, development facilities, early-stage process optimizationManufacturing plants, production floors, quality control labs
Industry UsageFocuses on developing and optimizing cell therapy processesInvolved in large-scale production and process execution

Cell Therapy Process Development professionals focus on designing and refining cell therapy procedures, while Cell Therapy Manufacturing Specialists handle the production and quality assurance in manufacturing settings. Both roles require similar educational backgrounds and certifications but differ mainly in their work environment and specific responsibilities.

What is cell therapy process development?

Cell Therapy Process Development refers to the design, optimization, and scaling up of manufacturing processes for cell-based therapies, such as CAR-T cells or stem cell products. Professionals in this field work on translating laboratory research into reproducible, efficient, and safe production methods that meet regulatory standards. This involves working with cell culture techniques, bioreactors, quality control, and process validation to ensure that therapies can be produced consistently for clinical and commercial use. The goal is to develop robust processes that deliver safe and effective cell therapies to patients.
What are popular job titles related to Cell Therapy Process Development jobs in Maryland? For Cell Therapy Process Development jobs in Maryland, the most frequently searched job titles are:
What job categories do people searching Cell Therapy Process Development jobs in Maryland look for? The top searched job categories for Cell Therapy Process Development jobs in Maryland are:
What cities in Maryland are hiring for Cell Therapy Process Development jobs? Cities in Maryland with the most Cell Therapy Process Development job openings:
Cell Therapy Process Development jobs near you
Infographic showing various Cell Therapy Process Development job openings in Maryland as of August 2026, with employment types broken down into 69% Full Time, and 31% Part Time. Highlights an 100% In-person job distribution.

Cell Therapy Strategy and Commercial Executive Director

AstraZeneca

Gaithersburg, MD • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 3 days ago

New

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

22nd of 86 rated pharmaceutical

Job description

Within the AstraZeneca Cell Therapy Enterprise, our ambition is to realize the full potential of cell therapy for people living with cancer, immune-mediated and rare diseases around the world. This unit has responsibility for the value chain from discovery through to late-stage development and commercialization. We are rapidly progressing a broad pipeline of cell therapies in collaboration with AstraZeneca's Therapeutic Area Units.
The Strategy and Commercial Executive Director, Cell Therapy Strategy and Commercial (CTSC), is a high-impact leadership role accountable for shaping and driving the end-to-end strategy for a defined indication or disease area within Cell Therapy. You will lead global commercial and strategic initiatives within the Cell Therapy Enterprise CTU)-including business development and competitive intelligence-partnering with Therapeutic Areas on clinical strategy, collaborating with in-market commercial and medical affairs on launch readiness, and aligning with global pricing and brand teams. Working cross-functionally with senior leaders, you will define early asset, disease, and portfolio strategies through PH3IDs. Reporting to the VP, Cell Therapy Strategy and Commercial, you will be a key architect of the company's Cell Therapy strategy and lead cross-functional execution.
Key Accountabilities:
Deliver end-to-end Strategy, including:
  • Clear understanding and prioritization of current and future unmet needs
  • Indication-level strategic vision for both near-term and long-term
  • Integrated clinical strategy across all cell therapy platforms within the same indication
  • Work with global Clinical and ClinOps within respective TAs to develop comprehensive development strategy
  • Competitive early pipeline / long-term portfolio and life cycle management
  • Above-asset initiatives (e.g., Translational Medicine, Precision Medicine, Data Sciences)

Own insights generation for R&D and commercial activities
  • Oversees and guides development and integration of industry-leading competitive intelligence, customer insight, market intelligence and analytics helping the organization to frame business problems and opportunities
  • Shape future-proofed strategies and deliver sustainably differentiated brands/early assets, business development opportunities and TA strategies
  • Responsible for the robustness and transparency of the forecasts for PH3IDs
  • Bring an intelligence-driven perspective to strategic recommendations by synthesizing insights from diverse sources and publicly available information at the brand and Therapeutic Area level for internal and external communication
  • Responsible for creating and curating evidence bank from real world data sources to support the PH3ID forecasts created within the team

Lead global commercial cell therapy within indication
  • Build the referral capabilities between specific disease areas and the Cell Therapy delivery centers
  • Partners closely across different areas of Cell Therapy, Global Commercial, in-market commercial and medical affairs teams to ensure execution of global strategy
  • Lead and collaborate with cross-functional teams (e.g., GPTs, Clinical Development, Discovery, BD, Lifecycle and Pipeline, Competitive Intelligence) to develop disease area strategy content
  • Provide strategic counselling to Global Clinical Strategy Head (GCSH), Global Commercial and Medical Affairs leadership, and other senior leaders

Basic Qualifications:
  • BA/BS and 10 years of experience in life sciences or consulting firm with focus in life science programs
  • OR MS/MBA and 8+ years of experience in life sciences or consulting firm with focus in life science programs
  • OR PhD or MD and 5+ of experience in life sciences or consulting firm with focus in life science programs
  • Ability to interact and communicate effectively with senior executive teams.
  • Demonstrated ability to lead and influence experienced professionals.
  • Ability to think critically, creatively and to anticipate and solve problems.
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment

Preferred Qualifications:
  • Strong analytical and communication skills
  • Strong business acumen and strategic thinking skills preferably demonstrated in a pharma related environment.
  • Effective interpersonal and relationship management skills with consultative approach and ability to interact and build trust
  • Operational effectiveness, highly organized process with follow through
  • Strong initiative to understand our core business goals and establish processes or programs to set direction, generate alignment and push forward
  • Financial background and understanding of forecasts, budgets, financial activities and tools
  • Resourceful, motivated, influential and proactive; able to prioritize in a fast-growing organization
  • Experience in strategic planning processes and tools
  • Scientific background
  • Understanding of the pharmaceutical business (including R&D)
  • Experience in translating business needs into a coordinated plan from cross-functional senior leadership team
  • Ability to develop creative and simple solutions to complex problems

In-Office Working Requirements
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. This role can be based in Gaithersburg MD, Boston MA, South San Francisco CA, New York NY.
The annual base pay for this position ranges from $267,914 to $401,870. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
06-Aug-2026
Closing Date
27-Aug-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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