Senior Scientist, Protein and Immunogenicity Assays

JOB PURPOSE

Sana Biotechnology is involved in developing gene and cell therapeutics for the treatment of a broad range of diseases and conditions. Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute that vision. The qualified candidate will have the ability to exercise independent judgment in planning, design, development, and execution of multiple, complex research projects that support the goals of the scientific research and projects with high level of independent judgment and minimal requirement for a supervision.

The Senior Scientist will be a highly motivated individual with a proven track record in bioanalytical science, leadership, collaboration work, and management experience. The role will have a key leadership role in the Pharmacology and Toxicology department with the responsibility to provide scientific, technical and strategic guidance and oversight for bioanalytical deliverables focusing on Sana's gene and stem cell therapy portfolio, spanning from early discovery research through IND enabling studies and beyond. The qualified candidate will be prepared to apply their experience in developing bioanalytical methods designed to detect protein and cellular analytes of interest as well as immunogenicity induction responses. Strong familiarity with steps required in assay development, qualification and sample analysis is required. The successful candidate will be expected to directly contribute to data generation, also to lead a team of scientists within the Bioanalytical Sciences group. The Senior Scientist will be expected to contribute to the authoring and compiling of key regulatory documents as well as possible communications with regulatory and health authorities, including FDA and EMA. The success will also be measured by the ability to scale their team while continually optimizing productivity.

The successful candidate will work with the Vice President within the BAS group to ensure development and integration of future strategies for the bioanalytical support of gene and cellular therapeutics, analytical platform / technology development, process improvements and operational compliance.

DUTIES AND RESPONSIBILITIES

Key accountabilities include:

• Directly contribute to data generation
• Lead a team of colleagues in the generation and interpretation of bioanalytical data to enable project milestone delivery and advancement of key platform technologies across multiple projects
• Direct responsibility and oversight of the design and implementation of project-specific bioanalytical strategies
• Ensure on-time delivery of high-quality bioanalytical data to support detection of protein and cellular analytes of interest, as well as immunogenicity induction responses
• Actively contribute to relevant regulatory documents, including IND, BLA, communications related health authority interactions and other scientific contributions. Paly critical role representing BAS to provide responses to regulatory requests and inquiries
• Design, completion and communication of required bioanalytical investigations ensuring scientific integrity of methods and data generated internally and in partnership with CROs
• Play a leading role within sub teams and functions by representing BAS group
• Comply with company policies, best practices and standard laboratory practices as required for the role. Author relevant policies and practices documents when appropriate
• Consult on bioanalytical activities conducted at CROs, including assay development, validation, troubleshooting, implementation for GLP and GCP support
• Interface with key stakeholders within Sana to understand, deliver, and communicate key bioanalytical results and conclusions
• Ensure influence of and alignment with key regulatory guidelines
• Co-lead in influencing the strategic direction of the BAS development
• Direct management, supervision, and mentorship of team members
• Direct responsibility and leadership in leading and training the next generation of bioanalytical scientists and Bioanalytical Principal Investigators
• Act as an expert consultant and scientific resource for others in the department
• Develop and implement innovative experimental bioanalytical methods, techniques and technologies to advance, improve or optimize scientific practices and procedures, pursue bioanalytical innovations aiming to improve scientific practices and procedures.
• Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.

Basic Qualifications

• PhD in Immunology, Biochemistry or other related fields with at least 5 years or MS with 10 years of relevant experience with a proven proficiency in independent research, design of laboratory experiments and techniques
• Strong and proven experience in bioanalytical method development, qualification and sample analysis is required
• Proven track record in the area of biotherapeutics bioanalysis with understanding of a broad range of bioanalytical platforms including ligand binding and Cell based assays is required
• Experience in communicating across disciplines to enable maximum impact of bioanalytical science is required
• Ability to author technical documents, e.g. data summary reports and bioanalytical procedures is required
• Industry experience with a focus in biotherapeutics development is desired
• Strong familiarity with a wide array of protein characterization protocols is desired
• Experience in working with various cell culture systems is desired
• Experience in developing methods for detection of cellular immunity is desired
• Direct experience in interacting with external organizations, including CROs, is desired
• Experience in gene and / or cell therapies development is a plus
• Familiarity with molecular biology protocols (qPCR, ddPCR, RT-PCR) is a plus
• Understanding of GLP / GCP regulations related to assay validation and sample analysis is a plus
• Experienced with interpersonal skills and an ability to adapt communication style to interact effectively with a range of collaborators including research associates, technical experts, computational biologists, cell biologists, and therapeutic teams
• Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams
• Demonstrated extensive direct experience in mentorship/supervision of junior level scientists and other Bioanalytical Principal Investigators
• A co-author on internal/external publications or posters

PHYSICAL REQUIREMENTS

• Carrying, handling and reaching for objects up to 25 lbs
• Prolonged standing and/or sitting
• Exposure to hazardous/toxic/dangerous chemicals
• Manual dexterity required to operate office and lab equipment