Principal Scientist, NGS Assays

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Job description

About the role

Genomics is a vital technology for advancing our gene & cell therapies at Sana. The Analytical Genomics team provides NGS-based capabilities across Sana using both internal and external sequencing technologies (Illumina, PacBio, and Oxford nanopore). This role is accountable for the design, development, execution and analysis of NGS-based analytical assays for cell & gene therapy applications from research through preclinical including transfer of SOPs to external CLIA certified labs. A successful candidate will be technically rigorous and have strong experience in automated NGS assay development and genomic data analysis with outstanding communication skills.

The ideal candidate will have a strong foundation in molecular biology techniques with hands-on experience in the areas of NGS assay development (RUO, IVD and/or CLIA) with demonstrated ability to adapt and optimize methods established in academic labs for biotech applications. The ability to deliver on multiple projects in a fast-paced environment, influence within and across functions, and work in a highly collaborative, multi-site company will be critical to successfully utilize genomics to advance gene and cell therapies.

What you'll do

• Design, implement and optimize NGS-based assays, develop well defined QC metrics and success criteria for each assay, and drive cross-functional projects to successful completion
• Drive development efforts to optimize assay performance, improve laboratory processes, and ensure assay robustness
• Document study protocols and methods; transfer SOPs and monitor & train external CROs on method implementation as appropriate
• Conduct troubleshooting investigations and related experiments to address acute or systematic issues with assays
• Identify areas for improvement in current assays and propose & implement solutions
• Act as a technical lead for NGS-based analytical assay development across Sana
• Mentor more junior staff in analytical NGS methods development & data interpretation; manage 2-3 direct reports as appropriate
• Author study protocols and write technical reports to support regulatory submissions as necessary
• Be highly committed to deliver results in a fast-paced and rapidly growing organization
• Collaborate closely with the Computational Biology team to develop study designs & analysis of results and the Computational Engineering team to develop data analysis pipelines
• Collaborate closely with the Automation team to implement NGS-based assays in a high-throughput and efficient manner
• Present results regularly at various group and cross-disciplinary meetings, and communicate effectively with a broad audience with a range of technical, analytical, and biological expertise

What we're looking for

• PhD/MD in molecular biology, biochemistry, genetics or a related scientific discipline with 8+ yrs experience in academic research and/or industry; expert knowledge of scientific principles and concepts in NGS methods development
• Prior experience in NGS assay and reagent development, testing, troubleshooting and optimization with hands-on laboratory experience and in-depth knowledge of nucleic acid extraction, library preparation and NGS sequencing
• Solid understanding of relevant regulatory agency guidance for analytical assays
• Ability to deliver results consistently and effectively, and quickly adapt to changing business conditions; has a demonstrated track record of delivering results
• Hands-on experience with methods & assay development for an RUO or IVD product and/or operating within a CAP/CLIA environment
• Excellent understanding of genetics, molecular biology, and assay development as demonstrated by publications, patent applications, and/or previous product development experience
• Strong experience with experimental design including demonstrated ability to be adaptable and simplify studies to meet business objectives and resource limitations
• Experience leading a small team
• Ability to independently perform basic bioinformatics analysis of NGS data
• Exceptional verbal and written communication skills
• Strong analytical, critical thinking and decision-making skills, and detail oriented
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana's culture

What will separate you from the crowd

• Prior experience with contributing to NGS data generation for IND submissions
• Direct experience with product development in a biotech/pharma setting including delivering a product to market and/or clinical therapeutic candidate to IND
• Hands-on experience with liquid handlers and/or partnering with automation engineers to build end-to-end NGS-based workflows for high throughput assay deployment and data integration with LIMS/ELN
• Direct experience with reducing turnaround time and costs for assay deployment, and identification & resolution of efficiency gaps
• Broad experience in developing -omics technologies (e.g. proteomics, metabolomics)
• Single cell sequencing, gene editing and/or methylome experience

What you should know

• Working safely on a predictable and regular basis is an essential job function for this position and the Company requires that all individuals, subject to certain exceptions, be fully vaccinated against COVID-19

How we work together

• Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations
• Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
• Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short- and long-term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.