Senior Scientist, Molecular Bioanalytical Sciences

Location
Cambridge
Posted
Sep 06, 2020
Ref
4589878002
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
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. Exercises independent judgment in planning, design, development, and execution of multiple, complex research projects that support the goals of the scientific research and project goals. Minimal guidance on all projects. Projects require use of independent judgment.

The Senior Scientist will be a highly motivated individual with a proven track record of scientific, leadership, collaboration work, and management experience who plays a key leadership role in the Pharmacology and Toxicology department. The Senior Scientist will provide scientific, technical and strategic leadership and oversight the bioanalytical sciences deliverables focusing on Sana's gene and stem cell therapy portfolio, spanning early discovery research through IND enabling studies to enable advancement of drug candidates. The Senior Scientist will apply their experience in molecular assay method development, qualification and validation, as well as experience in sample analysis, to lead a team of high-level scientists. The Senior Scientist will be expected to directly contribute to data generation and team management. 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 (FDA, EMA, etc.). The Senior Scientist will also be measured by their ability to scale their team while continually optimizing productivity, revenue.

DUTIES AND RESPONSIBILITIES

Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
  • Actively contributes to the strategic direction of the department and company objectives in creative and effective ways.
  • Plays a leading role within sub teams and functions.
  • Generates data, presents data and collaborative plans to management, partners and collaborators, as well as at conferences and regulatory meetings as appropriate
  • Ensure delivery of high-quality bioanalytical data to support PK/PD studies and regulatory documents (IND, BLA, global filings) as well as health authority interactions and scientific contributions
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
  • Provides mentorship to others by leading in presentations and scientific discussion.
  • Comply with standard laboratory practices and company policies
  • Liaison to development function and executive leadership regarding project timelines and deliverables.
  • Provides strategic direction in creating patent applications.
  • Creates strategic partnerships that lead to collaborations through networking and publication.
  • Write Standard Operating Procedures (SOPs) for department when appropriate
  • Understand and apply relevant scientific literature to the design of experimental protocols. This may include literature from outside of the Scientist's primary field of research.
  • Act as an expert consultant and scientific resource for others in the department.

QUALIFICATIONS

Basic Qualifications

PhD in scientific discipline with at least 5+ years with laboratory experience in an academic or industry setting or a Masters' degree in a scientific specialty with a minimum of ten years of experience and proven proficiency in independent research and in the design of laboratory experiments and techniques may provide the necessary experience.
  • Well versed in a wide array of molecular biology laboratory techniques (such as RT-PCR, ddPCR, viral genome quantification, etc.) and experienced in their use. Strong publication record from graduate and post-doctoral work is expected.
  • Actively engaged with developing and maintaining cross functional networks within the larger enterprise.
  • 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.
  • Experience across all phases of drug development required, experience in gene therapy or stem cell therapy drug development preferred
  • Technical proficiency, scientific creativity, strong collaboration/influencing and independent thought.
  • Solid knowledge of GLP practices for bioanalytical laboratories and familiarity with ICH, FDA and EMA guidance, as well as USP and industry suggested best practices, regarding bioassay advancement and management
  • 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.
  • Accustomed to working in a fast-paced, dynamic environment
  • Experience training and developing advanced scientific personnel

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