CSI Tech is searching for a Principal Scientist, Formulations for a pharmaceutical company located in the Nashville, TN area. This is an exciting opportunity for a motivated professional to carve out a progressive career path!
Salary: 130k-150k plus a 10%-15% annual bonus and profit sharing plan.
Relocation: Yes, relocation assistance is provided.
Candidates must be able to work in the US without sponsorship.
The Principal Scientist, Formulations, is responsible for leading activities of formulation development. This leadership position is responsible for creating formulation and drug development strategies. The ideal candidate will have small and large molecule formulation experience in both early and late phase development. This position is heavily focused on parenteral solution, suspension, and lyophilization formulations. Other dosage formulation experience is also highly desirable. The company is seeking an adaptable, disciplined, and dependable individual with broad formulation experience.
Identifies drug product critical quality attributes impacting safety, efficacy, and manufacturing robustness. Provides input to define phase appropriate regulatory specifications.
Performs screening of buffers, excipients, solubilizers, etc.
Identifies, evaluates, and develops novel delivery systems (i.e. controlled or sustained release.)
Designs and executes formulation protocols.
Experimental design, data evaluation, generation of scientific reports, and coordination of studies.
Designs and executes Admixture / Device compatibility studies.
Independently designs stability studies and in vitro experiments to understand quality attributes to support formulation development and optimization.
Designs Drug Product Shipping / Storage / Boundary conditions studies.
Collaborates with project teams to meet project objectives, budget, and timelines.
Leads and participates in formulation and product development and stability assessment activities that may include candidate screening and selection, developing lyophilized, spray dried, or liquid formulations for preclinical evaluation, clinical studies and commercialization.
Analyzes complex data, interprets and integrates experimental results with project objectives
Performs general lab housekeeping, including cleaning/sterilizing of lab and lab materials, and ordering and stocking supplies.
Mentors others, as assigned.
Develops and maintains a comprehensive understanding of regulatory guidance pertaining to drug product development.
Adept at learning about and assessing new technologies in formulation, devices, and analytical methods.
Able to handle multiple tasks while meeting timelines and adapting to changing priorities.
Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Bioengineering or related field with at least 6 years of relevant industry experience or MS with over 8 years experience
B.S./M.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Bioengineering or related field with over 10 years experience.
Candidates must have strong leadership ability, exceptional communication and interpersonal skills, be able to work in a dynamic environment, and prioritize work as assigned.
Sound knowledge and guidance in providing leadership to direct reports. Highly motivated and self-directed
Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Bioengineering or related field with at least 6 years of relevant industry experience or MS with over 8 years experience.
Experience in early stage formulation development.
Must have experience with controlled release delivery systems, micro/nanoparticles, hydrogels, polymers, liposomes, devices, etc.
Theoretical and practical knowledge of formulation development and characterization principles.
Must be detail oriented, be able to recognize subtle trends in data, have good problem- solving abilities, and possess an ability to grasp the big picture.
Enthusiasm in science with a motivation for making contributions in a team environment is necessary.
Experience applying QbD principles to analytical method, process, and product development.