Sr. Scientist - Assay Development in Houston, TX at Labtopia Inc.

Date Posted: 6/22/2020

Job Snapshot

Job Description



Job Description—         Sr. Scientist - Assay Development (1568)

Position Summary:

Our client in the Bryan/College Station, TX area is looking for a Sr. ScientistAssay Development to develop, design, execution, and transfer of biological, biochemical, and molecular assays to support product development, process characterization, and early state (Preclinical, Phase I/II) production of biotherapeutic molecules.

Essential Functions:

Design and Implementation Strategies:

  • Develop and implement assay strategies for screening biological targets, characterization of in process samples and ultimately transfers these assays to QC for testing
  • Validate established assays to ensure characterization and ID of peptides and proteins including but not limited to antibodies, subunit vaccines, virus-like particles, growth factors, and cytokines
  • Develop and qualift assays for the ID, optimization, and characterization of recombinantly produce therapeutics (i.e. release assays)
  • Development/adaptation of assays for comparisons with innovator therapeutics
  • Grow, maintain, and generate target cell lines for use in cell based assays for determining activity and potency of recombinant drugs including those made from plant-based expression platform
  • Develop and standardize fluorescent, chemiluminescent, and flow cytometric based assays including but not limited to ADCC and CDC assays to determine activity of high value plant or cell based therapeutics (including monoclonal antibodies (mAbs), vaccine antigens, growth factors, and cytokines)
  • Maintain operations of in-house biosafety level 2 (BSL-2) facility

Oversee Assay Screening Operations:

  • Acquire and maintain required analytical instrumentation, reagents, and supplies for  molecular protein and cell based activity assays
  • Responsible for assay development, validation, and implementation to support activities essential for drug development and manufacturing
  • Provide technical information and experimental assay design for recombinant product screening
  • Develop efficient operational models involving assay instrumentation, design, and analysis to streamline the workflow

Provide Data Analysis and Management:

  • Collect and interpret data for biological characterization assays and comparative studies
  • Assist with data preparation for analysis and reporting

Staff Development & Training:

  • Manage personnel and the activities in molecular, protein, and cell based assays including training, materials control, and investigations
  • Help provide required trainings and maintain current knowledge of industry standards
  • Direct and oversee experimental design and results of associates and technicians

Collaborate with Other Teams:

  • Work with members of early stage product development groups (molecular biology and process development), manufacturing, quality control, and quality assurance
  • Work in a QC role to generate biochemical test results for reports
  • Pepare technical reports, summaries, protocols, and quantitative/qualitative analyses
  • Maintain excellent communication across all research project teams and departments
  • Collaboration with other members of the R&D teams regarding assays, assay development, and the data analyses
  • Establish and manage relationships with external collaborators and vendors

Prepare Reports and Documentation:

  • Develop screening protocols for all types of cell based assays to include Flow Cytometry based cytotoxicity assays, proliferative and anti-proliferation assays, anti-fibrosis assays, host-cell protein assays, residual DNA assays and others as required
  • Participate in the evaluation of therapeutic technologies
  • Assist in the prep and presentation of clear technical reports, publications, and oral presentations
  • Prepare and author reports on program achievements, activities, and milestones
  • Record experimental results according to data collection guidelines and policies
  • Ensure that all research and development activities are documented and conducted in a sage manner in accordance with all applicable guidelines, standard operating procedures, and regulations

Other duties as required – be flexible

Qualifications:

  • Ph.D. and/or 10 years’ experience in molecular biology techniques and experience in developing biochemical and cellular assays, especially enzyme-linked immunosorbent assays (ELISA) type assays
  • Must have  strong foundation in experimental design and ability to execute complex experiments
  • Experience in cGMP regulated environment required

Other Skills and Abilities:

  • Must be knowledgeable in post-translational protein modifications including glycobiology
  • Knowledge of lab safety protocols, plant-transient expression systems, standard analytical techniques including but not limited to SDS-PAGE, ELISA, and Western blot required
  • Knowledge of optical methods, screening reagents, design of novel assays required
  • Must be very detail oriented and skilled in documentation
  • Skilled in computer functions such as MS office, data visualization, cell sorting, FACS, Biacore, and basic internet usage
  • Ability to make decisions and recommendations
  • Ability to demonstrate professionalism with personnel and management
  • Ability to multitask and delegate
  • Ability to maintain process and analytical equipment
  • Must have strong attention to detail and organization
  • Must be able to communicate effectively (written and oral)
  • Ability to gather and analyze information skillfully

Salary:

Please provide salary request

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