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.
Duties and Responsibilities
Achieves results with a high level of independence and uses judgement to solicit guidanceLeads technical aspects of projects, and may act as a subject matter expert to provide support and guidance for other projectsDevelops broader technical strategy and specific experimental work plansPerforms and/or supervises experimental execution as appropriate to ensure quality of the resultsAnalyzes data, draws conclusions, and proposes next steps to meet project milestonesAuthors and reviews technical reports and presentationsInterfaces with clients through verbal and written communicationsEffectively communicates with internal stakeholders to manage project timelines and strategyAdapts approach to evolving project requirementsMentors, and may manage employeesCoordinates the work of other team membersProvides technical guidance and mentorshipMay have direct reports and provide constructive and timely performance evaluationsResponsibilities may increase in scope to align with company initiatives Performs related duties as assigned
Required Skills and Abilities
Demonstrated experience with pharmaceutical product and process development, including amorphous dispersions and oral solid dosage formsExpertise with common unit operations for spray drying, blending, milling, granulation, compression, fluid bed coating, and encapsulationUnderstanding of formulation concepts and material properties of common excipientsDemonstrated experience in process development activities that support process validation, and familiarity with appropriate regulatory expectations and industry practicesDemonstrated experience with transfer of manufacturing processes into GMP environments and / or process transfer between different manufacturing sitesDemonstrated experience with principles of risk-based decision making and common tools for risk analysisAbility to apply rigorous scientific and engineering principles to guide practical decisionsAdvanced laboratory and data analysis skillsExcellent verbal and written communication skillsExcellent time management skills, with an ability to prioritize and / or delegate tasks appropriately to meet deadlinesExcellent leadership and collaboration skillsAbility to function well in a high-paced and at times stressful environment
Education and Experience
B.S. in Science or Engineering discipline with 10+ years of experience M.S. in Science or Engineering discipline with 8+ years of experiencePh.D. in Science or Engineering discipline with 3+ years of experienceCombination of degree and experience required, and:
3+ years of experience on projects where the key deliverables required GMP execution
Physical Requirements
Adheres to consistent and predictable in-person attendanceProlonged periods of sitting or standing at a desk and working on a computer
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
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.
