Principal Scientist (Process Definition and Scale-Up)

Serán BioScience • Bend, OR

10h • Onsite

About The Position

The Principal Scientist, Development Project Lead will lead projects that scale up and define the processing space of oral solid pharmaceutical products as they advance into and through stage 1 of process validation. Success in this role also includes a smooth transfer of technical knowledge to the commercial operations team, participation in stage 2 process validation, and provision of ongoing support throughout the product lifecycle. The Principal Scientist will interface with different departments within the company to ensure project success and will serve as the technical point of contact for the project sponsors. The Principal Scientist is expected to integrate the efforts of experts across different technical areas into a cohesive project strategy. This role requires the individual to blend strong fundamental knowledge with practical, risk-based decision making to identify solutions that meet quality and schedule expectations for the project sponsors.

Requirements

• 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
• Combination of degree and experience required, and:
• 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

Responsibilities

• 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

Benefits

• Serán employees accrue over four weeks of paid time off annually.
• Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period.
• Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions.
• Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage.
• An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level