Process Development Principal Scientist

hace 8 horas


Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

Summary: We are seeking a highly skilled and innovative Lead Scientific Research Specialist to develop projects/programs and contribute to novel experimental strategies and scientific vision. The ideal candidate will function as a lead scientific resource with cross-functional impact, capable of managing and leading scientific projects that may involve cross-functional areas. This role guides the successful completion of major programs by functioning in a project leadership role or as the lead scientific/technical resource. The candidate will provide guidance in resolving scientific/technical issues within the function/department, work independently, and integrate activities with other functions/departments.

Functions:

  • Develop and contribute to novel experimental strategies and scientific vision.
  • Guide the successful completion of major programs by leading projects or acting as the lead scientific/technical resource.
  • Provide guidance in the resolution of scientific/technical issues within the function/department.
  • Work independently and integrate activities with other functions/departments.
  • Evaluate progress toward goals and achievement of milestones for the work group.
  • Anticipate complex technical problems and develop practical and innovative solutions.
  • Develop novel processes or approaches to solve problems within a broad discipline within the work group.
  • Identify and analyze factors and trends outside the immediate area that impact the project or function/department.
  • Frequently introduce or create new technologies and concepts.
  • Lead teams contributing to the achievement of department/project/product team objectives.
  • Coach, motivate, and provide career and scientific/technical advice to colleagues within the function/department.
  • Communicate and/or present scientific/technical information to diverse audiences, including senior management and the external scientific community.
  • Apply knowledge of the drug discovery and development process to guide functions/departments.
  • Act as a scientific/technical expert within the function/department.
  • Lead the development of key scientific/technical documents.

Skills:

  • Working knowledge of pharmaceutical/biotech processes.
  • Familiarity with documentation in a highly regulated environment.
  • Ability to operate specialized laboratory equipment and computers.
  • Ability to interpret and apply GLPs and GMPs.
  • Develop solutions to routine technical problems of limited scope.
  • Problem-solving and applied engineering skills.
  • Basic technical report writing and verbal communication skills.
  • Technical presentations, personal organization, managing change, technical (equipment specific), analytical problem-solving, and computer literacy.
  • Interact effectively with various communication and working styles.
  • Ability to independently determine when additional internal resources are required to solve problems.
  • Handle multiple projects simultaneously.
  • Schedule development, facilitation, collaboration, and follow-up.
  • Provide solutions to a variety of technical problems of moderate to large complexity and scope.
  • Problem-solving skills requiring the application of scientific theory and calculations and creative skills in the development of hypotheses and approach.
  • Working knowledge of financial analysis tools.
  • Ability to delegate and manage the project work of others.
  • Negotiation, persuasion, facilitation, collaboration, project cost development, conflict resolution, leadership and team-building skills.
  • Management of contractors and vendors.
  • Knowledge of theories and principles related to leading-edge technologies.
  • Advanced technical expertise in at least one specialty area.
  • Ability to motivate and communicate visions/missions.
  • Advanced project management, presentations to large groups, external networking, and personnel coaching and development.

Requirements

Qualifications:

  • Doctorate degree and 3 years of Scientific experience OR
  • Master’s degree and 6 years of Scientific experience OR
  • Bachelor’s degree and 8 years of Scientific experience.

Preferred Qualifications:

  • Mechanical Engineering, Industrial Engineering, Chemical Engineering, Electrical Engineering, or Scientist.
  • Experience in Combination Products or Medical Devices.
  • Characterization and Validation experience.
  • Development and execution of Characterization and Validation protocols.
  • Device assembly experience.


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