Technical Development Principal Scientist

This role is a senior-level position within Analytical Development, focused on creating and implementing robust analytical methods to characterize and release cell therapy products. You will use state-of-the-art analytical assays to support process development, product characterization, release, and stability, while serving as a subject matter expert on cross-functional teams.

Responsibilities

• Develop and adapt analytical methods for cell therapy product release and characterization by designing and executing studies using Design of Experiments (DoE).
• Design and execute exploratory experiments to define critical quality attributes (CQAs) and optimize existing analytical methods.
• Independently research, plan, and perform experiments, analyze data, and recommend next steps to internal and cross-departmental stakeholders.
• Perform risk and gap assessments for analytical methods to enhance compliance, robustness, and overall method reliability.
• Execute routine laboratory experiments in collaboration with junior technical staff, ensuring generation of high-quality data through best practices in assay and instrument operation.
• Perform detailed data analysis, document study outcomes and conclusions, and summarize and present findings to key stakeholders.
• Design, execute, and approve method development, transfer, and qualification activities in support of process development, product characterization, product release, and stability programs.
• Lead lifecycle management of analytical assays by trending data, assigning appropriate controls, and maintaining assay performance over time.
• Author standard operating procedures (SOPs), assay development and qualification reports, and sections of regulatory documents related to analytical methods.
• Ensure adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of analytical data to support regulatory filings.
• Collaborate with cross-functional teams to advance the development of cell therapy products.
• Support the training and mentorship of junior Research Associates and other team members as needed.
• Manage multiple projects in parallel, including key participation in multi-disciplinary project teams.
• Apply critical thinking, troubleshooting, and problem-solving skills to resolve complex analytical and technical challenges.
• Maintain strong attention to safety, good laboratory practice (GLP), and good documentation practice (GDP) in all activities.

Requirements

• Master’s degree with 6–9 years of experience in analytical development, quality control (QC), technology transfer, and method lifecycle management, or a Ph.D. in Immunology, Molecular Biology, Biochemistry, or a related scientific discipline with at least 2 years of industry experience.
• Expertise in flow cytometry and immunology, including analytical method development and method transfer to QC laboratories.
• Demonstrated leadership in method optimization and remediation, CMC tech-transfer, analytical control strategies, and method qualification/validation.
• Proficiency in experimental design, data analysis, control charts, and capability assessments using Design of Experiments (DoE).
• Ability to interpret and apply ICH guidances, cGMP, USP, and relevant regulatory requirements, as well as industry best practices for analytical method development, technology transfer, method qualification/validation, and process development.
• Comfort working in a fast-paced environment with minimal direction and the ability to adjust workload based on changing priorities.
• Excellent interpersonal, verbal, and written communication skills.
• Self-motivated and detail-oriented, with a willingness to take on responsibilities beyond the initial job description.
• Ability to manage multiple projects concurrently and contribute effectively to multi-disciplinary project teams.
• Strong critical thinking abilities, with demonstrated troubleshooting and problem-solving skills.
• Consistent attention to safety, good laboratory practice, and good documentation practice.

Skills

• Two or more years of relevant cell therapy industry experience.
• Experience with 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), and metabolic analysis.
• Experience working with cell therapy, T cell, and stem cell products.
• Experience in analytical development and QC for advanced therapies.
• Ability to collaborate effectively across functional groups and support training of junior team members.

Work Environment

This is an onsite role based at a modern biotechnology campus in San Diego. You will work in a laboratory environment that utilizes advanced analytical technologies, including flow cytometry, ddPCR, qPCR, Next-Generation Sequencing, and various cell imaging and potency assay platforms. The setting is fast-paced and dynamic, with cross-functional collaboration across development, QC, and process teams. You will follow established safety protocols, good laboratory practice, and good documentation practice, and adhere to regulatory and quality standards such as cGMP, ICH, and USP. The environment encourages innovation, scientific rigor, and teamwork, providing opportunities to lead method development initiatives and contribute to cutting-edge cell therapy programs.

Pay

The pay range for this position is $53.00 - $67.00/hr.

Benefits

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)

Schedule

This is a Contract, fully onsite position based in Oceanside, CA.