Associate Director, Assay and Process Development

Associate Director, Assay And Process Development

Reporting to the Chief Science Officer, the Associate Director, Assay and Process Development works within a high-complexity, cellular, and molecular testing laboratory to develop processes, procedures, and products from conception to production for GLP level pre-clinical test products.

• Lead team of scientists and engineers to plan and build processes for highly complex, high quality biochemistry and cell biology laboratory testing.
• Work directly with Principal Investigators and R&D Laboratory team to implement and maintain quality control of test processes.
• Develop new molecular assays for pre-clinical decision making, defining mechanisms of action in complex cell assay environment.
• Develop test quality criteria and generate data quality reports.
• Create assay/test performance specification documents in conjunction with CSO and Assoc/Director of R&D Laboratory
• Develop and review Feasibility and later Development Phase Plans and Reports with CSO, performing all relevant statistical analyses, and making specific recommendations based upon acceptance criteria conclusions.
• Create, lead, execute Definitive Screening Design, Design of Experiment statistical studies to identify controlling and interacting factors in high complexity live cell assays.
• Create and maintain process and procedure plans from concept through validation phases.
• Develop test/process scale up plans with CSO, Assoc/Director of R&D Laboratory, Oncology investigators.
• Create pre-clinical documentation with CSO and Director Oncology
• Participate in review and approval processes for each phase of assay development
• Create and implement a stringent program for maintenance and calibration of laboratory equipment with lab systems and facilities manager.
• Work with Director R&D Laboratory and Quality Manager to maintain a safe workplace.
• Support the Quality Manager with compliance for HIPAA requirements and laboratory standard operating procedures.
• Support lab quality assurance/quality control (QA/QC) programs.
• Participate in staff reviews as needed.
• Report to work as scheduled.

• Participate in set-up of and data generation for translational medicine clinical studies.
• Plan with other Directors and participate in routine science meetings with team members from Research, Development, and Tissue Culture Areas

• PhD/MS in related (bio) engineering field
• Extensive experience leading teams of scientists/engineers to solve complex problems and deliver results in a timely way.
• Extensive experience developing processes and pre-clinical assay products, developing and applying appropriate high complexity metrics and statistical analyses.
• Experience requiring a high percentage of hands-on time in the lab leading and working with teams to build processes and successful products.

• Language Ability:
  Ability to read and interpret documents such as safety rules, governmental regulations, and science/engineering technical or professional journals. Ability to write reports, document data; and to speak effectively before small groups.
• Math Ability:
  Ability to apply fractions, percentages, reliability and validity to work situations. Ability to work with logarithms and exponents. Ability to develop complex algorithms to analyze experimental data and apply those algorithms in an economical manner to process large data sets uniformly.
• Reasoning Ability:
  Ability to apply principles of scientific thinking to a range of practical and intellectual issues. Consistent use of inductive and deductive reasoning.
• Computer Ability:
  Proficiency in Microsoft Word, Excel, and PowerPoint, Statistical analysis (egs. JMP, R), Design of Experiment software, Mat Lab or equivalent, Solid Works or equivalent drafting software.
• Analytical
  - Synthesizes complex or diverse information;
  Collects and researches data;
  Uses intuition and experience to complement data;
  Designs workflows and procedures. Applies complex statistical analyses.
• Design
  - Generates creative solutions;
  Uses feedback to modify designs;
  Applies design principles;
  Demonstrates attention to detail.
• Problem Solving
  - Identifies and resolves problems in a timely manner;
  Gathers and analyzes information skillfully;
  Develops alternative solutions.
• Ethics
  - Works with integrity and ethically.
• Innovation
  - Displays original thinking and creativity;
  Meets challenges with resourcefulness;
  Generates suggestions for improving work;
  Develops innovative approaches and ideas;
  Presents ideas and information in a manner that gets others' attention.
• Judgment
  - Displays willingness to make decisions;
  Exhibits sound and accurate judgment;
  Supports and explains reasoning for decisions;
  Includes appropriate people in decision-making process;
  Makes timely decisions.
• Planning/Organizing
  - Prioritizes and plans work activities;
  Uses time efficiently;
  Plans for additional resources;
  Sets goals and objectives;
  Develops realistic action plans.
• Quality
  - Demonstrates…