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Cambridge, Massachusetts Sana Biotechnology
JOB PURPOSE

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 successful individual brings drug development experience as a subject matter expert, exercises independent judgment in planning, design, development, and execution of multiple, complex projects that support the goals of the Sana organization, scientific research and project goals; and, has a demonstrated track record of building highly-effective cross-functional relationships resulting in organizational impact and being a supportive manager.

The Executive Director of Bioanalytical Sciences leads the development, implementation and standardization of critical bioassays in support of Sana's non-clinical and clinical development programs and is a contributing member/leader of project teams. This person will provide scientific, technical and strategic regulatory leadership in bioanalysis to support Sana's gene and stem cell therapy portfolio. The Executive Director will also work in collaboration with the Head of Quality to develop and implement processes and standards to ensure that the conduct and reporting of bioanalytical testing is in line with Good Laboratory Principles (GLP) as well as FDA, EMA, ICH and all other applicable regulatory requirements. The Executive Director must be a highly motivated individual with a proven track record of scientific leadership, collaboration work, management experience and the development of junior team members.

DUTIES AND RESPONSIBILITIES
  • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
  • Develop non-clinical and clinical assays that will be outsourced to contract research organizations (CROs) for cell and gene therapies including; protein based assays (e.g. immunoassays, western blot, HPLC etc), molecular assays (e.g. quantitative PCR), immunogenicity assays (e.g. ADA, NAB, Elispots etc)
  • Hands on experience and knowledge of the development of assays for fit-for-purpose versus qualified versus validated
  • In conjunction with the project teams, determine the overall assay strategy for development programs
  • Coordinate CRO and vendor selection (e.g. quotes, capabilities assessments, site audits), oversee contracts/SOWs process
  • Review and approve bioanalytical protocols, reports, and related documentations
  • Ensure delivery of high-quality bioanalytical data and regulatory documents (IND, BLA, global filings) as well as health authority interactions and scientific contributions
  • Ensure regulatory compliance and scientific oversight of internal as well as external bioanalytical programs to meet the demands of agencies within the US and ex-US (e.g. EMA etc)
  • Manage timelines and resourcing for delivery of assays, data and reports to support regulatory filings
  • Leads project teams, and cross functional initiatives as needed
  • Communicate results, progress and issues to project teams
  • Contribute to organizational and functional goals and business processes as a member of the Pharmacology and Toxicology Leadership Team
  • Manage a team of bioanalytical scientists in support of Sana cell and gene therapy programs
  • Provide scientific guidance, career development, mentoring and training to junior staff
  • Develop and manage related fiscal budgets, staffing, and planning processes
  • Ensure new bioanalytical technologies are being assessed and incorporated when appropriate.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review

Basic Qualifications
  • PhD in scientific discipline with at least 10+ years with laboratory experience in an academic or industry setting or a Masters' degree in a scientific specialty with a minimum of 15+ years of experience and proven proficiency in independent research and in the design of laboratory experiments and techniques may provide the necessary experience. Must have at least 5+ years of management experiences of direct reports.
  • Hands-on experience developing molecular biology, cell biology, biochemistry and immunology methods
  • Thorough knowledge of assay development and validation under GLP, FDA, EMA, ICH and other applicable guidelines
  • Experience coordinating and managing CROs and vendors under tight timelines
  • Excellent organizational, planning, and multi-tasking skills
  • Strong communication (oral and written) and interpersonal skills
  • Experience across all phases of drug development required, experience in gene therapy or stem cell therapy drug development preferred
  • History of conducting and overseeing the analysis of clinical and nonclinical samples for all therapeutic programs in a GLP laboratory
  • Experience across all phases of large molecule drug development required, experience in gene therapy or stem cell therapy drug development preferred
  • Ability to manage bioassay development, optimization and qualification within a CRO or with CRO partners
  • Ability to work collaboratively with stakeholders to resolve issues

Preferred Qualifications
  • Ability to manage bioassay development, optimization and qualification within a CRO or with CRO partners
  • Experience in direct interactions and communication with regulatory and health authorities (FDA, EMA, etc.)
  • Experience in authoring and reviewing critical documentation critically reviewed new technical documents, protocols and reports connected to assay development, validation and clinical sample testing, biomarker elements in IND filing documents
  • Experience in the development of cell-based assays and biomarker discovery
  • Accustomed to working in a fast-paced, dynamic environment
  • Experience training and developing advanced scientific personnel
  • Demonstrated ability to manage complex projects and programs
  • Detail-oriented with strong focus on accuracy, while still being able to see the big picture

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