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Process Development Principal Scientist- 35490

Juncos, Puerto Rico
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

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