The Senior Scientist, Development Project Lead will oversee sponsored projects to develop formulation strategies and manufacturing processes for oral solid pharmaceutical products used in human clinical trials. They will coordinate and integrate the work of subject matter experts from different functional areas to meet the target product profile and manufacturing needs of the sponsor. Project milestones typically include lead selection from multiple prototypes, production of pre-clinical toxicological supplies, and demonstration of at-scale manufacturing processes as a precursor to transfer to the clinical manufacturing environment. Proactive and effective communication with the project sponsor and with other departments within the company is essential for success. In addition to project leadership, the role also provides ample opportunities for technical mentorship of project team members.
Duties and Responsibilities
Serves as the technical lead for multiple externally-sponsored projects; may also lead internally-sponsored projectsDevelops comprehensive and practical project strategy and timelines and aligns development work with the timelines and requirements for clinical manufacturingReviews, and may create, specific work plans, slides, and reports as appropriateReviews data across the project to ensure holistic interpretation and strategyProvides clear guidance to project team members regarding technical deliverables and timelinesIdentifies and resolves or escalates conflicts relating to project deliverables and technical strategyServes as primary point of contact for technical communications with the project sponsor and drives the communication strategy for regular project meetingsCollaborates with other technical experts to provide mentorship for scientists and engineers in area(s) of expertiseContributes to scoping for new projectsMay supervise others and perform job functions within the capacity of supervisorResponsibilities may increase in scope to align with company initiativesOther duties as assigned
Required Knowledge Skills and Experience
Excellent verbal and written communication skillsExcellent organizational skills and attention to detailExcellent time management skills with a proven ability to meet deadlinesDemonstrated ability to collaborate and work in cross-functional teamsAbility to function well in a high-paced and at times stressful environmentScientific curiosity and willingness to learnDemonstrated experience in formulation sciences and drug product developmentCommunicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the companyDemonstrated ability to collaborate and work in cross-functional teamsDemonstrated experience with advanced laboratory and data analysis skillsStrong analytical and problem-solving skillsAbility to prioritize tasks and to delegate them when appropriateAccepts feedback from a variety of sources and constructively manages conflict
Education and Experience
B.S. in Science or Engineering discipline with 5+ years of experience,M.S. in Science or Engineering discipline with 3+ years of experience, or PhD in Science or Engineering discipline
Physical Requirement
Prolonged periods of sitting or standing at a desk and working on a computerMust be able to lift up to 25 pounds regularly and up to 50 pounds occasionallyAdheres to consistent and predictable in-person attendanceMotor skills required for basic laboratory operations (pouring liquids, using utensils to transfer powders, visual assessments)
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.