Technical Development Principal Scientist

The ideal candidate will have a strong track record in analytical and process development, demonstrated expertise in method development and lifecycle management, and the ability to thrive in a fast-paced, dynamic environment. Design, execute, and approve method development, method transfer, and method qualification activities supporting process development, product characterization, product release, and stability programs.

Technical Development Principal Scientist
Location: San Diego, CA 92111
Contract Duration: 6 Months — Potential Extension or Full-Time Conversion
Pay Rate: $55.17–$68.97/hour (W2)
Benefits: Weekly Pay, Medical, Dental, and Vision Insurance
 
Position Summary
We are seeking an experienced and highly motivated Technical Development Principal Scientist to join our client's Analytical Development team in San Diego, CA. This role will support the PTCC team in developing robust analytical methods for cell therapy product characterization and release.
The successful candidate will develop, optimize, and apply state-of-the-art analytical methods to characterize cell therapy products and processes. This individual will critically evaluate scientific data and study protocols, lead analytical development initiatives, and collaborate with cross-functional teams as a subject matter expert.
The role is also responsible for ensuring that analytical methods and generated data are fit-for-purpose, scientifically sound, robust, and compliant with applicable regulatory requirements.
The ideal candidate will have a strong track record in analytical and process development, demonstrated expertise in method development and lifecycle management, and the ability to thrive in a fast-paced, dynamic environment.
 
Key Responsibilities

• Develop, optimize, or adapt analytical methods for cell therapy product characterization and release by designing and executing studies using Design of Experiments (DoE).
• Design and execute exploratory studies to identify and define Critical Quality Attributes (CQAs) and improve existing analytical methods.
• Independently research, plan, and execute experiments; analyze scientific data; determine appropriate next steps; and provide recommendations to internal and cross-functional stakeholders.
• Conduct risk and gap assessments for analytical methods to improve compliance, reliability, and robustness.
• Execute routine laboratory experiments in collaboration with junior technical staff while following established assay, instrument, laboratory, and safety best practices.
• Analyze data, document study outcomes and conclusions, and prepare technical presentations for key stakeholders.
• Design, execute, and approve method development, method transfer, and method qualification activities supporting process development, product characterization, product release, and stability programs.
• Lead the lifecycle management of analytical assays, including data trending and establishment of appropriate controls.
• Author and review SOPs, assay development reports, qualification reports, and regulatory documentation.
• Ensure analytical data and documentation meet high technical standards and applicable regulatory and quality requirements for regulatory submissions.
• Collaborate with cross-functional teams to advance the development and commercialization of cell therapy products.
• Provide technical guidance and training to junior Research Associates and other team members as needed.
• Serve as a subject matter expert and provide scientific leadership across analytical development initiatives.

 
Required Qualifications

• Master's degree with 6–9+ years of experience in analytical development, QC, technology transfer, method development, or analytical method lifecycle management; OR
• Ph.D. in a relevant scientific discipline such as Immunology, Molecular Biology, Biochemistry, or a related field, with 2+ years of industry experience.
• Strong expertise in flow cytometry and immunology-based analytical method development.
• Demonstrated experience transferring analytical methods to Quality Control (QC) laboratories.
• Proven leadership experience in:
  • Analytical method optimization and remediation
  • CMC technology transfer
  • Analytical control strategies
  • Method qualification and validation
• Strong proficiency in experimental design, data analysis, control charts, and capability assessments using DoE.
• Working knowledge of and ability to interpret and apply ICH guidelines, cGMP, USP standards, regulatory requirements, and industry best practices.
• Experience with analytical method development, technology transfer, qualification/validation, and process development.
• Ability to work independently in a fast-paced environment with minimal supervision and adapt to changing priorities.
• Excellent written, verbal, interpersonal, and cross-functional communication skills.
• Self-motivated, detail-oriented, and willing to take on responsibilities beyond the initial scope of the position.
• Ability to manage multiple projects simultaneously and contribute effectively to multidisciplinary project teams.
• Strong critical thinking, troubleshooting, and problem-solving skills.
• Commitment to laboratory safety, Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).

 
Preferred Qualifications

• 2+ years of industry experience in cell therapy.
• Experience developing or supporting analytical control systems for stem cell and T-cell products.
• Experience with one or more of the following analytical techniques:
  • ddPCR
  • qPCR
  • Cell imaging
  • Reporter-based potency assays
  • Cell engineering
  • Next-Generation Sequencing (NGS)
  • Metabolic analysis

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