SUMMARY:
To develop projects/programs and contribute to novel experimental strategies and scientific vision.
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 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.
EDUCATION:
- Doctorate PhD + 2 years of Scientific or Engineering experience.
- Masters + 5 years of Scientific or Engineering experience.
- Bachelors + 7 years of Scientific or Engineering experience.
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.
- Prompt and regular attendance to workplace. Although main working hours are regular 8:00 am to 5:00 pm the candidate need the flexibility to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.
- Meet specific project team goals and timelines.
- Develop project plans and strategies for implementation working with project managers and SMEs.
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.
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.
- Ability to delegate and manage the project work of others.
Demonstrated Skills in the following areas:
- 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.
Demonstrated Skills in the following areas:
- Advanced project management.
- Presentations to large groups.
- External networking.
- Personnel coaching and development.
WORK METHODOLOGY:
- Full on site job in Juncos, PR
- Full time job
- Expected project duration: 6 months for the first contract with a high possibility of extension based on performance and budget.
- Administrative Shift (weekends and overtime may also be required).
- Expected hiring date: August 2026