Process Development Principal Scientist 35490

SUMMARY

The Process Development Principal Scientist provides scientific and technical leadership in the planning, execution, and management of Process Development initiatives supporting manufacturing operations and capital projects within a regulated pharmaceutical or biotechnology environment. This role leads cross-functional projects, develops implementation strategies, manages technical risks, and ensures successful project execution while maintaining compliance with cGMP and applicable regulatory requirements.

EDUCATION

• Master's Degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related scientific discipline with a minimum of five (5) years of relevant scientific or engineering experience; or
• Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related scientific discipline with a minimum of seven (7) years of relevant scientific or engineering experience.

PREFERRED QUALIFICATIONS

Candidates should demonstrate strong experience in Process Development, Scientific Project Management, and Manufacturing Support , including the following:

Process Development Project Leadership

• Lead Process Development projects from planning through execution, monitoring, completion, and project closeout.
• Develop project strategies, implementation plans, timelines, and resource allocation plans.
• Coordinate project activities to ensure milestones, deliverables, and business objectives are achieved.
• Support the development of technical and financial business cases for new initiatives.

Scientific & Technical Support

• Independently evaluate technical challenges and apply sound scientific and engineering principles to develop practical solutions.
• Perform scientific investigations with clearly defined objectives and analyze experimental or operational data.
• Identify opportunities for process optimization, operational excellence, and continuous improvement.
• Apply Lean Six Sigma methodologies to improve process performance and project execution.

Cross-Functional Collaboration

• Partner with Manufacturing, Process Engineering, Maintenance, Quality Assurance, Validation, and other technical organizations to successfully implement Process Development projects.
• Collaborate with Subject Matter Experts (SMEs), Project Managers, and stakeholders to ensure alignment across project activities.
• Support technical discussions, project meetings, and stakeholder communications throughout the project lifecycle.

Project Planning & Risk Management

• Develop detailed project plans, schedules, and implementation strategies.
• Identify project risks, resource constraints, and schedule impacts.
• Develop and implement mitigation plans to maintain project quality, efficiency, and timelines.
• Balance multiple priorities while maintaining a high level of scientific and operational performance.

Compliance & Documentation

• Ensure all activities are performed in accordance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, and internal quality procedures.
• Maintain complete and accurate project documentation in accordance with documentation standards.
• Ensure assigned training requirements are completed and maintained.
• Support inspection readiness and regulatory compliance throughout project execution.

Operational Support

• Support manufacturing operations during standard and non-standard working hours, including extended shifts, weekends, or 24/7 operations, as project needs require.
• Maintain regular workplace attendance and provide flexibility to support evolving business priorities.
• Meet established project goals, deliverables, and timelines while maintaining quality standards.

DESIRED COMPETENCIES

The ideal candidate demonstrates:

• Strong scientific and technical leadership
• Excellent project management and organizational skills
• Ability to lead multiple projects simultaneously
• Strong analytical thinking and problem-solving abilities
• Experience with Process Development in a regulated pharmaceutical or biotechnology environment
• Knowledge of cGMP regulations and quality systems
• Experience applying Lean Six Sigma and Operational Excellence methodologies
• Excellent written and verbal communication skills
• Ability to collaborate effectively across cross-functional teams
• Strong decision-making and risk assessment capabilities
• Adaptability to changing priorities and fast-paced project environments
• Commitment to continuous improvement and operational excellence