Scientist, Drug Product Development

AstraZeneca; Gaithersburg (MD); On-site; USD 100,000 - 170,000; Full time

Job summary

AstraZeneca is seeking a Scientist, Drug Product Development to advance LVV drug product formulations and processes for clinical programs in cell therapy and gene therapy. In this hands-on role, you will design, execute, analyze, and report development studies and collaborate with Process Development, Analytical Development, Manufacturing, and Regulatory teams to deliver data packages.

The position emphasizes laboratory work, data-driven decision making, and interaction across cross-functional

Qualifications

• Ph.D. or MS with relevant industry experience in drug product development.
• Hands-on experience with LVV or viral vectors is desirable.
• Ability to design, execute, and interpret formulation studies.
• Strong data analysis and cross-functional collaboration skills.

Responsibilities

• Design, execute, and document formulation development studies for LVV drug products.
• Plan and perform laboratory and pilot-scale drug product studies for fill-finish.
• Collaborate with Analytical Development, Manufacturing, and Quality teams.
• Author development reports and support regulatory submissions.
• Transfer technology to internal sites or CDMOs and troubleshoot campaigns.

Skills

Formulation Development

Drug Product Process Development

Stability Studies

Technology Transfer

Regulatory Submissions

Cross-functional Collaboration

Education

PhD in Pharmaceutical Sciences

MS with 4-6 years experience

Job description

AstraZeneca is seeking a highly motivated and experienced Scientist, Drug Product Development to support drug product development activities for lentiviral vector (LVV) programs within our Cell Therapy and Genetic Medicines portfolio. The successful candidate will contribute to the development of robust drug product formulations and processes that enable clinical advancement of ex vivo and in vivo cell and gene therapy programs.

In this hands-on laboratory-based role, the Scientist will be responsible for designing, executing, analyzing, and reporting drug product development studies supporting formulation development, fill-finish processes, characterization, stability assessments, and technology transfer activities. The position requires close collaboration with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and external partners to deliver high-quality scientific data and development packages.

Key Responsibilities

Formulation Development

• Design, execute, and document formulation development studies for LVV and other viral vector drug products.
• Evaluate formulation components and process conditions to improve vector stability, potency, and product quality.
• Generate scientific data to support selection of platform and program-specific formulations.
• Analyze study results and present findings to cross-functional teams.

Drug Product Process Development

• Plan and perform laboratory and pilot-scale drug product studies supporting fill-finish process development.
• Support evaluation of filling processes, container closure systems, storage conditions, and delivery configurations.
• Execute studies related to freeze-thaw performance, hold-time assessments, and hoop-paritioning.
• Participate in development and optimisation of drug product manufacturing processes.

Characterisation and Stability Studies

• Design and execute stability studies to support product development and regulatory submissions.
• Collaborate with Analytical Development to assess critical quality attributes, including potency, infectivity, particle characteristics, and product integrity.
• Interpret experimental results and provide data-driven recommendations.
• Support development of stability-indicating strategies and shelf-life assessments.

Technology Transfer Support

• Support drug product technology transfer activities to internal manufacturing sites and external CDMOs.
• Generate development data and documentation required for scale-up and process transfer.
• Participate in troubleshooting activities during manufacturing campaigns and process implementation.
• Assist in development of scale-down models and comparability studies as needed.

Documentation and Regulatory Support

• Author protocols, technical reports, development summaries, risk assessments, and manufacturing support documents.
• Maintain accurate laboratory records in accordance with company and quality requirements.
• Contribute to preparation of CMC documentation and technical sections for regulatory submissions, including IND-enabling packages.
• Ensure activities are conducted in compliance with applicable quality systems and regulatory expectations.

Cross-functional Collaboration

• Work closely with Upstream and Downstream Process Development, Analytical Development, Manufacturing, Quality, and Regulatory teams to advance development programs.
• Communicate scientific findings clearly through written reports, presentations, and team discussions.
• Contribute technical expertise during project planning and development strategy discussions.
• Support problem-solving and investigation activities across development programs.

Innovation and Continuous Improvement

• Stay current with emerging drug product and formulation technologies relevant to viral vectors and cell therapy products.
• Identify opportunities to improve laboratory workflows, experimental approaches, and development processes.
• Contribute to implementation of new technologies and best practices within the organization.

Qualifications

Education

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, Bioengineering, or related scientific discipline with 0-2 years of relevant industry experience; OR
• M.S. with 4 -6 years of relevant industry experience.

Experience

• Hands-on experience in drug product development for viral vectors, cell therapies, biologics, vaccines, or related modalities.
• Experience designing and executing laboratory studies independently.
• Demonstrated ability to analyze complex datasets and generate clear scientific conclusions.
• Experience working in cross-functional development teams.

Technical Expertise

• Working knowledge of one or more of the following areas: Formulation development
• UF/DF operations
• Drug product process development
• Fill-finish processes
• Container closure systems
• Particle characterization
• Stability study design and execution
• Viral vector or biologics manufacturing processes

GMP & Regulatory Knowledge

• Understanding of cGMP principles and quality systems.
• Familiarity with