Director, Analytical Development

Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about designing gene circuits to improve the “intelligence” of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines are unable to address. 

At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.

Summary:

Senti Bio is seeking an experienced Director to lead our analytical development group for our cell therapy programs. A successful applicant will have prior experience taking a novel cell therapy through IND and be comfortable in a fast moving and nimble culture. Applicants should have current and extensive knowledge of supporting the development of cell products (e.g. CAR T, CAR NK). This role will lead the development of analytical methods for characterization and release testing as well as the tech transfer of assays to CDMOs. We are seeking individuals who are passionate about the future of “smart therapeutics” and have the energy and boldness to thrive and grow in a dynamic and fast startup environment. The individual will be a member of the Tech Ops /CMC leadership team and will have the opportunity to contribute to the overall CMC development strategy for cell therapy products.

Responsibilities:

• Oversee all analytical development activities for Senti's cell therapy development programs, with a focus on CAR-NK and CAR-T cell therapies and associated starting materials such as leukopaks and feeder cells.Work closely with the research team to understand key requirements and guide early decision making to enable seamless transfers and development of methods to support characterization and release testing.
• Develop strategy and plans for assay qualification or validation including strategy for creating and qualifying critical assay controls and reagents.
• Experience and knowledge of various analytical methods including flow cytometry, cell counting, PCR, infectious titer, ELISA, cell-based potency, safety related assays (replication competent virus, human viruses) and compendial methods such as mycoplasma, sterility, and bioburden.
• Experience with analytical methods that support release and characterization testing of viral vectors including retrovirus and lentivirus along with experience with plasmid associated assays.
• Develop assay transfer protocols and execute assay transfer to CDMOs in support of external manufacturing and testing.
• Play a central role in selection and interaction with contract manufacturers, key suppliers, and other external vendors.
• Work with Regulatory in support of regulatory filings and writing INDs.
• Maintain thought leadership with the current cell therapy ecosystem and bring best practices to the organization.
• Coordinate tasks across multiple projects. Make decisions on prioritization and planning. Be the key driver to meet project timelines and milestones.
• Experience with GMP requirements, regulatory standards and expectations (FDA, EMA, ICH), root cause analysis, OOS/deviation investigations, change control process, SOP/protocol authoring and report writing.
• Provide leadership to analytical development staff on assay development techniques/strategies, communication/presentation skills, and career development.
• Experience with oversight of analytical and stability activities at CDMOs including technical, quality and financial aspects.
• Ability to establish assay development roadmap, department budget, training plans, and assimilate new technologies.

Qualifications:

• BS/BA degree with 15+ years of experience or MS/PhD degree with 10+ years of experience in a cell therapy development setting.
• 10+ years of cell therapy analytical development experience from proof-of-concept to clinical manufacturing.
• Significant management experience with multiple direct and indirect reports, including leading laboratory operations.
• Experience developing methods for lentiviral, retroviral, and other ex vivo cell engineering vector platforms.
• Desired experience includes late stage/commercial product development, hands on QC testing or QC lab management, and interaction with regulatory authorities.
• Familiarity with IND regulatory requirements, GMP requirements, and quality documentation.
• Experience working with and managing CDMO (i.e, training, transfer, and oversight of QC groups)
• Demonstrated ability to work independently in a multi-functional project at a fast moving organization.

Salary and Benefits:

• Compensation for this role includes base salary, annual target bonus and equity
• The base salary range for this role is $210,000-$230,000. Starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
• Significant growth opportunity as the company expands
• Empathetic, supportive and collaborative colleagues and work environments

Senti Bio is a publicly traded (Nasdaq: SNTI) gene circuit company headquartered in South San Francisco. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches.

We are committed to an inclusive and diverse Senti Bio. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Senti Team. We welcome people of different backgrounds, experiences, abilities and perspectives and are an equal opportunity employer.