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About the role

Sana is seeking an exceptional Senior Leader to join our dynamic team and supporting CMC development of novel gene and cell therapy drug substances and products. We are looking for new team members who believe in the potential of engineered cells as medicines, who want to challenge the status quo, and who lead with the desire to work on novel ideas. As a Head Molecular Analytical Development, you will report to the VP, Head of Analytical Development and develop a world-class analytical team to drive gene/cell therapy product and process understanding.

What you’ll do

The experienced leader in this role will build a world-class capability with an expert analytical team to drive product and process understanding. The leader will oversee assay strategy and implementation including automation, testing operations, and data analysis across a portfolio of technologies. The leader will partner closely with process and formulation development to guide strategy and manage analytical development to design quality into the CMC packages for novel gene and cell therapies from Phase 1 through Commercialization. The individual will play a key role in building out the control strategy for Sana’s investigational products and participate in cross-functional program teams.

The successful candidate will have industrial experience managing an analytical development team for gene/cell therapy preferred (biologics/vaccines may be acceptable), have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing team.

• Develop/oversee strategy for staged deployment of analytical methods and testing during early platform technology and CMC development. With innovation and pragmatism, accelerate the learning curve and long-term success of developing innovative new products by (1) supplying advanced analytical capabilities (with high volume and rapid turnaround time) to guide research & early CMC development, (2) enabling early and deep insights into quality attributes and process parameters, (3) critically informing the selection/optimization of product candidates, and (4) supporting the rapid translation of product candidates into the clinic and successfully through commercialization
• Establish high throughput testing capabilities (non-GMP) to support CMC development of Sana’s gene/cell therapy programs. Adapt methods to address the throughput and technical demands of fast-paced early development programs and the demands for simple, rapid, cost-effective testing of commercial products. Assay families will include: biochemical, molecular biology (PCR, ddPCR), immunoassays (ELISA), cell-based (flow cytometry), and biophysical
• Manage a team of scientists to develop, operationalize, and oversee analytical methods and their application in building product insight and solving complex process and formulation development challenges
• With a focus on technical excellence, the individual will oversee assay optimization, implementation, performance, troubleshooting, and analysis of results
• With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost
• Participate in establishment of drug substance and drug product specifications for IND, IMPD, and BLA submissions. Review/author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA)

What we’re looking for

• PhD and 10 plus years of experience or MS and 12 plus years of experience or BS and 14 plus years of experience
• Experience with the following methods /technologies: cellular, biochemical and molecular biological (PCR, ddPCR) methods, immunological methods (ELISA, MSD), spectroscopic and fluorescent methods, flow cytometry, NGS technologies, HPLC, automated liquid handling (preferred, not required)
• Prior experience leading a team in Analytical method development, testing, QC, or stability is important
• Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hands-on experience
• Must have excellent written, verbal and organizational skills
• Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects
• Demonstrates a respect for others and is open to new/different ideas
• Working safely in person on a predictable and regular in-person basis is an essential job function for this position

What will separate you from the crowd

• Expert knowledge of principles and concepts and is a thought leader; has experience managing department(s) with senior employees
• Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in analytical sciences for characterization of biological products, associated product-related species, and process residuals/impurities

What you should know

• The base pay range for this position at commencement of employment is expected to be between $230,000 and $270,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience