Principal Scientist (Process Definition and Scale-Up)

• Achieves results with a high level of independence and uses judgement to solicit guidance
• Leads technical aspects of projects, and may act as a subject matter expert to provide support and guidance for other projects
• Develops broader technical strategy and specific experimental work plans
• Performs and/or supervises experimental execution as appropriate to ensure quality of the results
• Analyzes data, draws conclusions, and proposes next steps to meet project milestones
• Authors and reviews technical reports and presentations
• Interfaces with clients through verbal and written communications
• Effectively communicates with internal stakeholders to manage project timelines and strategy
• Adapts approach to evolving project requirements
• Mentors, and may manage employees
• Coordinates the work of other team members
• Provides technical guidance and mentorship
• May have direct reports and provide constructive and timely performance evaluations
• Responsibilities may increase in scope to align with company initiatives
• Performs related duties as assigned

• Demonstrated experience with pharmaceutical product and process development, including amorphous dispersions and oral solid dosage forms
• Expertise with common unit operations for spray drying, blending, milling, granulation, compression, fluid bed coating, and encapsulation
• Understanding of formulation concepts and material properties of common excipients
• Demonstrated experience in process development activities that support process validation, and familiarity with appropriate regulatory expectations and industry practices
• Demonstrated experience with transfer of manufacturing processes into GMP environments and / or process transfer between different manufacturing sites
• Demonstrated experience with principles of risk-based decision making and common tools for risk analysis
• Ability to apply rigorous scientific and engineering principles to guide practical decisions
• Advanced laboratory and data analysis skills
• Excellent verbal and written communication skills
• Excellent time management skills, with an ability to prioritize and / or delegate tasks appropriately to meet deadlines
• Excellent leadership and collaboration skills
• Ability to function well in a high-paced and at times stressful environment

• B.S. in Science or Engineering discipline with 10+ years of experience
• M.S. in Science or Engineering discipline with 8+ years of experience
• Ph.D. in Science or Engineering discipline with 3+ years of experience

• 3+ years of experience on projects where the key deliverables required GMP execution

• Adheres to consistent and predictable in-person attendance
• Prolonged periods of sitting or standing at a desk and working on a computer

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.