Title: Process Development Principal Scientist (Job ID: 35490)

Location: Juncos, Puerto Rico (Open to Puerto Rico Residents)

Schedule: On-site | Administrative Shift (8:00 AM – 5:00 PM with Flexibility to support a 24/7 manufacturing operation when business needs require)

Duration: 5-Month Contract

Positions Available: 1

Position Summary

Our client is seeking an experienced Process Development Principal Scientist to provide scientific leadership and technical expertise in support of process development initiatives and strategic projects. This role will lead cross-functional scientific efforts, drive project execution, develop innovative solutions, and contribute to the successful implementation of complex programs in a highly regulated pharmaceutical manufacturing environment.

The ideal candidate is a collaborative scientific leader with strong project management experience, excellent technical judgment, and the ability to influence cross-functional teams while ensuring compliance with cGMP and regulatory requirements.

Required Qualifications

• Minimum of 7 years of relevant scientific or engineering experience, depending on education level.
• Working knowledge of pharmaceutical or biotechnology manufacturing processes.
• Experience working in highly regulated environments.
• Familiarity with cGMP, GLP, regulatory documentation, and quality systems.
• Ability to operate specialized laboratory equipment and computerized systems.
• Strong technical judgment and analytical thinking.
• Ability to independently solve technical problems of moderate to high complexity.
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Flexibility to support a 24/7 manufacturing operation when business needs require.

Primary Responsibilities

• Lead and support all phases of project management, including planning, execution, monitoring, completion, and follow-up activities.
• Manage Process Development (PD) projects, including timelines, resource allocation, deliverables, and project priorities.
• Partner with Manufacturing, Process Engineering, Maintenance, Quality Assurance, Validation, and other cross-functional teams to successfully execute projects.
• Develop project implementation strategies in collaboration with project managers and subject matter experts (SMEs).
• Prepare comprehensive business cases that include technical evaluations and financial considerations.
• Identify project risks, scheduling challenges, and resource constraints while developing effective mitigation plans.
• Ensure compliance with domestic and international regulatory requirements, internal policies, and Standard Operating Procedures (SOPs).
• Balance multiple priorities while maintaining project quality, efficiency, and established timelines.
• Apply Lean Six Sigma, Operational Excellence, and Continuous Improvement principles to assigned projects.
• Independently evaluate, select, and apply standard engineering and scientific techniques.
• Perform assignments requiring investigation, analysis, and evaluation of technical variables.
• Ensure all activities are performed and documented in accordance with current Good Manufacturing Practices (cGMP), including required training compliance.
• Meet established project milestones, deliverables, and team objectives.
• Provide operational support outside regular business hours, including extended hours, weekends, or non-standard shifts when project needs require.

Key Functions

• Serve as a lead scientific resource with broad cross-functional impact.
• Lead scientific and technical projects involving multiple functional areas.
• Provide scientific leadership for major programs and strategic initiatives.
• Make recommendations that directly influence departmental and organizational objectives.
• Guide the resolution of complex scientific and technical issues.
• Work independently while coordinating activities across multiple departments.
• Exercise sound scientific judgment in determining project priorities and objectives.
• Monitor project progress, evaluate milestones, and implement corrective actions when necessary.
• Anticipate technical challenges and develop practical, innovative solutions.
• Design and introduce new scientific processes, technologies, and approaches.
• Analyze emerging trends and external factors that may impact projects or business objectives.
• Lead project teams in achieving departmental, product, and organizational goals.
• Mentor, coach, and provide scientific and technical guidance to colleagues.
• Present scientific and technical information to diverse audiences, including senior leadership and external scientific organizations.
• Apply knowledge of pharmaceutical drug discovery and development to support business objectives.
• Serve as the scientific and technical subject matter expert within the department.

Minimum Qualifications

Candidates must meet one of the following educational and experience requirements:

• Ph.D., Pharm.D., or M.D. (with relevant post-doctoral experience where applicable) plus 2 years of scientific experience; OR
• Master's Degree plus 5 years of scientific experience; OR
• Bachelor's Degree plus 7 years of scientific experience.

A degree in Science or Engineering is required.

Core Competencies

Technical Skills

• Pharmaceutical and biotechnology manufacturing processes
• cGMP and GLP compliance
• Applied engineering principles
• Scientific problem-solving
• Process development
• Specialized laboratory equipment
• Technical documentation and report writing
• Computer proficiency
• Analytical troubleshooting

Project Management

• Advanced project management
• Schedule development and execution
• Resource planning
• Financial analysis and project cost development
• Contractor and vendor management
• Risk assessment and mitigation
• Project implementation
• Follow-up and project completion

Leadership & Communication

• Cross-functional collaboration
• Leadership and team development
• Personnel coaching and mentoring
• Conflict resolution
• Negotiation and influence
• Facilitation skills
• Technical presentations to small and large audiences
• External networking
• Effective communication across diverse teams
• Ability to inspire, motivate, and communicate organizational vision

Scientific Expertise

• Advanced knowledge in at least one scientific or technical specialty
• Ability to develop innovative scientific approaches
• Application of scientific theory, calculations, and hypothesis development
• Knowledge of emerging technologies and industry-leading practices
• Ability to translate scientific findings into practical business solutions