About The Position

We are looking for a Process Development Principal Scientist to work with process engineering, optimization, and scale-up activities. You will be part of a team of talented researchers to design scalable, cost-effective, and compliant manufacturing processes. SUMMARY To develop projects/programs and contribute to novel experimental strategies and scientific vision.

Requirements

  • Doctorate PhD OR PharmD OR MD [+ relevant post-doc where applicable] + 2 years of Scientific experience OR Masters + 5 years of Scientific experience OR Bachelors + 7 years of Scientific experience.
  • Working knowledge of pharmaceutical/biotech processes.
  • Familiarity with documentation in a highly regulated environment.
  • Ability to operate specialized laboratory equipment and computers as appropriate.
  • Ability to interpret and apply GLPs and GMPs.
  • Able to develop solutions to routine technical problems of limited scope.
  • Demonstrated skills in the following areas: Problem solving and applied engineering, Basic technical report writing, Verbal communication
  • Demonstrated Skills in the following areas: Basic technical presentations, Personal Organization, Dealing with and managing change, Technical (Equipment Specific), Analytical Problem Solving, Computer Literacy, Specialized equipment/process expertise
  • Interacts effectively with variety of communication and working styles
  • Ability to independently determine when additional internal resources are required to solve problems
  • Ability to handle multiple projects at one time.
  • Demonstrated Skills in the following areas: Schedule development, Facilitation, Collaboration, Completion and follow-up.
  • Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
  • Problem solving skills requiring the application of scientific and theory and calculations and creative skills in the development of hypotheses and approach.
  • Working knowledge of financial analysis tools.
  • Knowledge of theories and principles related to leading edge technologies.
  • Advanced (industry level) technical expert in at least one specialty area.
  • Ability to motivate and communicate visions/missions.
  • Demonstrated Skills in the following areas: Advanced project management.
  • Presentations to large groups.
  • External networking.

Responsibilities

  • Functions as a lead scientific resource with cross-functional impact.
  • Capable of managing and leading scientific projects which may involve cross functional areas.
  • Guides the successful completion of major programs by either functioning in a project leadership role or as the lead scientific/technical resource.
  • Decisions or recommendations impact the ability to achieve functional /departmental objectives.
  • Provides guidance in the resolution of scientific/technical issues within the function/department.
  • Works independently and integrates activities with other function/department.
  • Exercises considerable latitude in determining objectives or assignments within the function /department.
  • Evaluates progress toward goals and achievement of milestones for work group, with limited additional oversight, may translate evaluation into appropriate action.
  • Anticipates complex technical problems and develops practical an innovative solutions.
  • Frequently develops novel processes or approaches to solve problems within a broad discipline within the work group.
  • Identifies and analyzes factors and trends outside immediate area that impact project or function/department.
  • Frequently introduces or creates new technologies and concepts.
  • Leads teams that contribute to the achievement of department/project/product team objectives.
  • Coaches, motivates and provides career and scientific/technical, advice to colleagues within the function/department.
  • Communicates and/or presents scientific/technical information formally and informally within area of expertise to a diverse set of audiences, including senior management and external scientific community.
  • Applies knowledge of drug discovery and development process to guide functions/departments
  • Act as scientific/technical expert within the function /department
  • Leads the development of key scientific/technical Comments.
  • Ability to delegate and manage the project work of others.
  • Personnel coaching and development.
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