Sr. Scientist, Analytical Development

Company: Simply Biotech
Location: Covina
Posted on: January 20, 2023

Job Description:

Sr. Scientist, Analytical Development- Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below. Immediate opening for a Sr. Scientist, Analytical Development, in Covina, CA who possesses:

• Ph. D or Masters Degree - Biochemistry, Cell Biology, Molecular Biology or related
• 6+ years of industry experience
• Strong experience with assay development
• Strong experience with Flow Cytometry or Molecular Assay or ELISA
• Cell and Gene therapy experience preferred Email resumes to rmontillo@simplybiotech com or call 949.204.3862 FULL DESCRIPTION: Our client is seeking a highly motivated (Principal/Senior) Scientist, Analytical Development, reporting to the Manager Analytical Development, developing analytical assays (molecular, bioassays, and immuno-assays inclusive) to support the development of novel modified autologous and allogeneic cell/gene therapies. This role will be responsible for preclinical and clinical assay development/ optimization/ qualification to support required testing of cell/gene therapies and viral vectors used in the manufacturing process. Additionally, some support for testing components and raw materials with contract laboratories may be required. The successful candidate will have extensive experience with cell/gene therapy analytical assay development, deep expertise on the underlying science and technology of these assays, and a detailed understanding of the CMC testing requirements for IND/NDA filings, and materials qualification The selected candidate will be responsible for:
  • Expert in analytical assay development adopting the quality-by-design concept to support testing of all pre-clinical and clinical cell therapy programs
  • Provide scientific input in all analytical development technical areas
  • Develop, perform troubleshooting and evaluation of analytical methods such as molecular/ biological/ immuno-assays, including ddPCR, qPCR, ELISA, flow cytometry, to support cell and gene therapy programs
  • Assist with test method development and qualification/ validation and establishment of specifications
  • Execute analytical methods to support analytical development, process development, and quality control
  • Perform equipment/instrumentation evaluation, execution of testing, and data interpretation of results
  • Author study protocols, development/qualification reports, test methods, relevant sections of regulatory submissions
  • Develop method platforms to support current and new products, increase method throughput, lower cost, and lower operational laboratory complexity
  • Work strategically to accelerate the development and implementation of novel testing technologies for integration into new and existing drug products
  • Working closely with other functions such as Research, Regulatory Affairs, Manufacturing, Quality, QC, clients MSAT and others
  • Prepare and present to management on analytical method development progress, latest data and conclusions, to meet client and testing development goals
  • Draft development reports and SOPs for new methods
  • Ability to adjusts to changing time lines and company needs
  • Builds a strong scientific and technical laboratory team, provides necessary training and ongoing coaching, discipline, and recognition of direct staff, including performing annual performance reviews
  • Support technology transfer of methods into the QC department, and serve as a key SME with external laboratory organizations and key clients as well as material/component and equipment/instrument vendors
  • Investigate and resolve problems, identify root cause, and propose laboratory operation improvements through clear communication to senior management
  • Interact with outside vendors and senior management
  • Participate in multi-functional project teams, as necessary
  • Take corrective action to bring about required changes using approved change control procedures The selected candidate will also possess:
    • In-depth experience and knowledge in biotherapeutics analytics with emphasis on cell-based potency methods, cellular characterization, viral characterization and infectivity assays, molecular methods, antigenicity methods, and other separation-based methods used for gene/cell therapies
    • Familiar with the FDA regulatory requirements for drug products and IND filing
    • Knowledgeable of cGMP processes and technology transfer
    • Understand requirements for product characterization and release tests
    • Demonstrated ability to design and execute laboratory experiments and evaluate data to provide scientific guidance on assay optimization
    • Demonstrated ability to technically trouble shoot and resolve assay challenges to successfully produce cell therapy products at a high-performance rate
    • Demonstrated ability to develop, qualify/validate and transfer biologics analytics into manufacturing processes and product testing that meet customer needs is required
    • Knowledge of method lifecycle management - from early to late-phase and throughout commercialization
    • Knowledge of cGMP in the pharmaceutical industry. Application to cell/gene therapy and viral vector development/manufacturing a plus
    • Familiar with data analytics software such as JMP, Minitab, and/or GraphPad Prism
    • Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
    • Strong problem-solving and organizational skills are required
    • Professional Knowledge
    • Problem Solving
    • Team Player / Building Relationships
    • Multi-tasking
    • Customer Focus
    • Action and detail oriented
    • Active Listening
    • Decisive Decision Making Salary Range: $125,000-140,000/yr For immediate and confidential consideration, please email your resume to rmontillo@simplybiotech com or call 949.204.3862 More information can be found at www.simplybiotech.com

Keywords: Simply Biotech, Covina , Sr. Scientist, Analytical Development, Other , Covina, California