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.