SUMMARYThe 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 QUALIFICATIONSCandidates 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 COMPETENCIESThe 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
