Process Development Principal Scientist

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

Expected hours: 40.0 per week

Experience:

• Project management: 3 years (Preferred)
• GMP: 3 years (Preferred)

Work Location: In person