Process Development Principal Scientist
hace 8 horas
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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