Cytokinetics is seeking an outstanding individual and scientist to join our formulation group, including responsibilities for development and manufacturing drug products for different stages of clinical studies. You will be part of the research team during pre-clinical formulation development and pre-formulation study.  You will provide critical support for the following activities: designing and developing of First-in-Human clinical formulations; tech transferring the prototype formulations to CRO/CMO; scaling-up and cGMP manufacturing of clinical trial materials; as well as trouble-shooting and process optimization of drug product as projects progress to next stage.

The Scientist I will utilize the internal formulation laboratory capabilities to develop prototype formulations for both preclinical and clinical studies.  Furthermore, the candidate will support formulation activities at various stages at CMO/CRO: First-in-Human simple clinical formulation, late-stage clinical formulation with robust manufacturing process, “proposed commercial” formulation for Registration / Primary Stability batches, and final formulation for process validation.  

Responsibilities

• Conduct prototype formulation and process development utilizing internal formulation laboratory capabilities, and support tech transfer and scale-up to CMO/CRO for continuous development. 
• Summarize experimental findings, review, and interpret study, results, assemble data packages
• Participate in activities at CRO/CMO for pre-formulation study, formulation and process development, as well as CTM manufacturing and packaging for drug products
• Review and prepare protocols and batch records, analyze in-process and analytical data, draw scientific conclusions, as well as prepare study reports and presentations
• Provide support to DMPK and Pharmacology team regarding pre-clinical formulation optimization and preparation
• Collaborate with process chemistry team for crystal form/salt selection and polymorph screening activities
• Characterize formulations prepared by CMO/CRO or internally through physical and analytical testing. Make informed discussions based on scientific data
• Contribute to drug product sections of regulatory filings such as INDs, IMPDs and NDAs
• Stay updated on principles and theories relevant to drug development. Actively participate in cross-functional team meetings and contribute to development plan
• Exhibit excellent writing and communication skills, both verbally and in writing. Interact effectively with colleagues
• This position requires on-site presence for a minimum of 3 days a week and may involve travel to oversee development and manufacturing activities at CROs/CMOs

Qualifications

• Ph.D. in Pharmaceutical Science, Chemistry, Chemical Engineering, or related discipline with 2+ years of experience
• Strong background in oral solid dosage forms including immediate and controlled released formulations
• Hands-on experience with various unit operation processes in lab scales for oral solid dosages
• Proficient in designing and executing experiments, analyzing samples in the formulation laboratory, and drawing conclusions and recommendation based on experimental data
• Sound understanding of the principles and practices of pharmaceutical science, with the ability to integrate and apply this knowledge effectively to formulation and process development
• Capable of applying Design of Experiment (DoE) statistical approaches during process optimization and scale-up, including knowledge of statistical programs for data analysis  
• Comfortable performing analytical tests and solid-state characterization independently, including techniques such as Dissolution, HPLC, DSC, TGA, XRPD, SEM, Laser Diffraction Particle Size Analyzer and Light Microscopy
• Experienced in pre-clinical formulation preparation and conducting pre-formulation studies
• Demonstrated ability to effectively work on multiple projects and capability of prioritizing various tasks under tight timelines
• Comfortable in dynamic, fast-paced, and high demanding environments
• Excellent interpersonal, communication and decision-making skills
• Proficient in writing technical reports (using Word), summarizing processing data (Excel), and facilitating discussions and conclusions (PowerPoint presentations) 
• Team player who enjoys working in the multidisciplinary environment