SUMMARY
To develop projects/programs and contribute to novel experimental strategies and scientific vision.
PREFERRED QUALIFICATIONS
- Specific responsibilities include but are not limited to:
- Support all phases of inspection project management—from planning and implementation to monitoring, completion, and follow-up—ensuring alignment with goals, timelines, and quality standards.
- Lead PD related Project Management projects and activities, timelines and resources allocation.
- Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to implement projects.
- Support the development of comprehensive business cases including technical and financial requirements.
- Identify potential project risks, schedule changes, or resource constraints. Develop and implement solutions to maintain scientific efficiency, quality, and client satisfaction.
- Maintain strict adherence to domestic and international regulatory requirements, internal policies, and standard operating procedures throughout the project lifecycle.
- Balance competing timelines and priorities, ensuring critical tasks are completed efficiently and project standards for quality and quantity are met.
- Provide flexibility to support extended hours, non-standard shifts, and evolving project demands as needed.
- Ensure activities follow cGMP procedures and are documented according to cGMP requirements including assigned training
- Independently evaluate, select and apply standard engineering techniques and procedures.
- Perform assignments that have clear and specific objectives and require investigation of limited number of variables
- Applies lean six sigma, operational excellence and continues improvement in assigned projects.
- Develop project plans and strategies for implementation working with project managers and SMEs.
EDUCATION
- Doctorate PhD + 2 years of Scientific or Engineering experience OR
- Masters + 5 years of Scientific or Engineering experience OR
- Bachelors + 7 years of Scientific or Engineering experience.
SHIFT
Administrative Shift (M-F) 9am-5pm. 8 hours per day. 40 hours per week. Must be willing to work outside of shift if needed.
FUNCTIONS
-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 and 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 the immediate area that impact a 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 an 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/departmentsAct as scientific/technical expert within the function /department Leads the development of key scientific/technical comments.
COMPETENCIES/SKILLS
-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.
-Problem solving and applied engineering
-Basic technical report writing
-Verbal communication
-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.
-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.
-Ability to delegate and manage the project work of others.
-Negotiation
-Persuasion and facilitation
-Collaboration
-Project cost development
-Conflict Resolution
-Leadership and teambuilding
-Management of contractors and vendors
-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.
-Advanced project management.
-Presentations to large groups.
-External networking.
-Personnel coaching and development.
Pay: $68.00 - $71.00 per hour
Experience:
- Project management: 3 years (Preferred)
- GMP: 3 years (Preferred)
Work Location: In person
