Senior Scientist, Analytical Sciences

We are seeking a collaborative and highly motivated Senior Scientist experienced in genomic, proteomic, cell-based assays to lead assay development to characterize gene editing materials. The individual will grow, manage, and mentor a lab-based team to deliver new/optimized analytical methods and evaluate new analytical technologies. The candidate will be responsible to develop analytical methods to characterize genome editing material(s) (e.g. CRISPR/Cas9 system) and to align with cellular therapy product CQAs to enable process development, product characterization, stability and release testing of novel engineered cell therapy products. They will author and review method development reports, test methods and SOPs, protocols, and assist in the technical review of CMC sections and supporting documents for regulatory filings. The Senior Scientist will work extensively with the Process Development and Quality Control teams. This role is based out of Santa Monica, CA and reports directly to the Associate Director, Analytical Development.

Essential Functions and Responsibilities

• Grow, manage and provide strategic, SME, technical and scientific leadership to a highly technical analytical method development team.

• Responsible to develop and implement genomic, proteomic, or in-vitro/ex-vivo functional assays from conceptual design to assay optimization, qualification, and method transfer to Quality Control and/or external partners as part of an analytical control strategy and in support of Process Development

• Work with Process Development, executing and documenting analytical methods as part of experimental study plans to progress and characterize CRISPR-based genomic editing tools and engineered cell product.

• Collect and monitor analytical results to continuously characterize CRISPR-based genomic editing tools and engineered cell therapy platforms in support of critical quality attribute assessment for CRISPR/Cas9-based genomic editing tools and AstraZeneca cell therapy products.  

• Work cross-functionally with Quality partners to draft study protocols, qualification reports, change controls and occasionally perform routine assays as a QC personnel for drug substance release and characterization.

• Employ quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.

• Write, review and edit accurate technical and development reports, CMC sections for regulatory submissions, and SOP/maintenance/user requirements for relevant equipment platforms.

• Provide technical guidance to junior staff, assign duties, review data, and reinforce regulatory concepts (cGMP)

• Participate in group and department meetings, present scientific data, provide expertise in areas of responsibility.

• Maintain, calibrate and operate analytical equipment and instrumentation that is used routinely in execution of assays.

Qualifications and Skills

• 5+ years with MS/MA; 2+ years with PhD in molecular biology, immunology, cell biology, or related discipline

• Demonstrate knowledge of CRISPR-based gene editing utilization in cellular and gene therapy products and analytical method development within a regulated environment

• First-hand experience in development and qualification of enzymatic functional assay, molecular biology assay, immunoassays, cell-based functional methods for release in a QC/regulated environment

• Hands-on experience in characterizing the precision, efficiency, and/or safety of CRISPR/Cas9 system, ribonucleoprotein complex (RNP complex) or other base-editing technologies in immune cells or other mammalian cells is required.

• Proficiency in molecular biology techniques, including cloning, qPCR, d(d)PCR, and NGS is a plus.

• Working knowledge and experience in physiochemical property characterization on protein enzymes using chromatography-based or mass spectrometry technology is a plus.  

• Excellent skills in Microsoft Excel, Word and Powerpoint and data analysis software (e.g. Prism, JMP, FlowJo, QIACuity Software Suite, SoftMax Pro)

• Demonstrate knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and statistical analysis.

• Ability to think critically and demonstrate troubleshooting and problem solving skills.

• Excellent interpersonal, verbal and written communication skills.

• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

• Experience and aptitude in working in a fast-paced laboratory environment with moderate direction and supervision.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to:

• Sit, stand, walk and communicate verbally (i.e. speak and hear). 

• The employee frequently is required to use their hands and arms to reach and grasp (i.e. tactile functioning). 

• The employee must occasionally lift and/or move up to 25 pounds. 

• Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

• The noise level in the work environment is usually moderate.

• May be required to travel by car 5% of the time.

• This position requires working with biological and/or chemical hazards.