Pre-Formulation Scientist

The Pre-Formulation Scientist I will serve as an integral member of the research team at Cytokinetics. The role will provide critical formulation support for nonclinical candidates, as well as enabling studies to contribute to both candidate selections and early formulation development.

Key Responsibilities

• Responsible for day-to-day small molecule and to lesser extent PROTAC molecules pre-formulation assessments of API and preclinical formulations to drive Cytokinetics early development programs and intellectual property, through a strong laboratory presence in our internal laboratory.
• Design and conduct development studies in-house (pre-formulation development as well as analytical characterization and control of small-scale stability studies), accurately interpret the outcome of the studies and propose appropriate follow-up studies with minimal guidance, applying scientific and regulatory knowledge.
• Support preclinical formulation delivery for PK, pharmacology, and toxicology studies to achieve the desired PK coverage in preclinical studies.
• Assessment of solubility and stability in a variety of biorelevant media and buffers
• Perform dose verification analysis using HPLC.
• Perform sophisticated, technically challenging experiments, efficiently and independently ensuring compliance by maintaining complete and accurate records of laboratory work in conformance with company best practices and training.
• Generate effective hypotheses to pursue project goals and set new experimental directions.
• Summarize experimental findings, review, and interpret study results, assemble data packages. Transfer laboratory procedures and methods to the CMC team.
• Develop novel and creative solutions to overcome project goal obstacles and pursue relevant intellectual property opportunities.
• Maintain up-to-date knowledge of applicable industry and regulatory guidelines and requirements.
• Build overall capabilities of our in-house laboratories
  
  

Education, Experience, And Qualifications

• Ph.D in Pharmaceutical Science, Chemistry, Chemical Engineering, or related discipline with 3+ years or BS/MS with 7+ years industry experience in pharmaceutical preclinical formulation development
• Strong knowledge of pre-formulation for small molecules and/or biopharmaceuticals, including an understanding of small molecule physicochemical stability, particularly for common routes of degradation
• Preferable strong knowledge in covalent-binding molecules and perhaps PROTAC formulations and analysis
• Diverse experience across multiple types of pre-formulation, formulation, and characterization methods
• Hands on experience with HPLC, LC-MS,SEC, and physico-chemical methods of analysis
• Regularly executes technically challenging, complex experiments successfully
• Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment, with the ability to adapt to rapidly changing priorities and deadlines
• Strong written and verbal communication skills, with the ability to develop strong collaborative working relationships with stakeholders and across functions
• Demonstrates initiative and ability to capitalize on scientific creativity and insights
• Demonstrated outstanding determination and/or persistence in supporting projects
• Highly motivated self-starter that works well both in teams and independently
• Demonstrated ability to accomplish results and meet deadlines and commitments
• Astute attention to detail and accuracy
• Demonstrated analytical and logic skills with a focus on data-driven decision-making
• Knowledge and experience with computational tools and statistical analyses is beneficial