Process Development Principal Scientist- 35490

CIS International•Juncos, PR

6h•Onsite

About The Position

To develop projects/programs and contribute to novel experimental strategies and scientific vision. 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.

Requirements

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.
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.
Knowledge of theories and principles related to leading edge technologies.
Advanced (industry level) technical expert in at least one specialty area.
Demonstrated Skills in the following areas: Advanced project management. Presentations to large groups. External networking. Personnel coaching and development.

Nice To Haves

Provide flexibility to support extended hours, non-standard shifts, and evolving project demands as needed.
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.

Responsibilities

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.
Provides guidance in the resolution of scientific/technical issues within the function/department.
Works independently and integrates activities with other 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.
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.
Ensure activities follow cGMP procedures and are documented according to cGMP requirements including assigned training.
Independently evaluate, select and apply standard engineering techniques and procedure.
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.
Meet specific project team goals and timelines.
Develop project plans and strategies for implementation working with project managers and SMEs.
Ability to delegate and manage the project work of others.
Ability to motivate and communicate visions/missions.