Scientist 1Location Novato, California
The selected candidate will work in the Formulation Development group to advance various therapeutics for clinical evaluation and eventual commercialization of drug products. The candidate will be responsible for developing and optimizing liquid and solid formulations, performing product characterization and supporting fill-finish manufacturing processes.
The successful candidate will be self-motivated individual with adequate experience in formulation/drug development and excellent inter-personal skills to work effectively in a dynamic and collaborative team environment. The ideal candidate is a self-starter familiar with the literature and keeps up with new developments in the field and is thus able to identify opportunities for innovation.
- Use advanced skills in experimental design, data analysis, problem solving and data presentation
- Provide concise and quantitative analysis of data and interpretation of experimental results
- Integrate experimental design expertise with technical knowledge
- Develops detailed understanding of drug/process development, validation and process transfer.
- Demonstrate Technical expertise and have enough experience in a broad range of basic and specialized methods
- Develop liquid and lyophilized formulations and define appropriate primary packaging and delivery devices for the finished drug products
- Plan and execute experimental studies in an efficient manner to develop formulations that meet project goals and timelines
- Employ various analytical instruments to conduct physicochemical/biophysical characterization of lead molecules
- Primarily an individual contributor, capable of working independently with minimal supervision.
- Keep up with new developments in field and is familiar with the scientific literature
- Possess strong analytical skills and good verbal and written communication skills
- Participate in internal and external scientific meetings
- Provide effective oral presentations at department and interdepartmental meetings
- Write experimental protocols and technical reports summarizing development work
- Report project progress to manager in timely manner
- Train and develop junior staff as needed
- May contribute to scientific publications and generate appropriate sections of drug product CMC dossier for regulatory submissions (IND/NDA, CTA/MAA).
- May lead one or more research associates/assistants and be able to balance scientific and supervisory responsibilities
- Maintain good and timely documentation of experiments and adhere to Good Laboratory Practices
- Knowledge of basic pharmaceutics principles and understanding formulation role in the drug development process
- Excellent understanding of protein chemistry, structure and function
- Experience with Formulation development activities including pH profiling, excipient/formulation prototype screening, drug product compatibility with fill-finish materials and primary container closure components, managing stability programs and other characterization studies relevant to ensuring robust and scalable formulation selection.
- Excellent communication, collaboration and writing skills
- Demonstrated ability to present results in both oral and written formats is required
- Proven application of relevant analytical methods and techniques to characterize molecules
- Experience authoring development reports, scientific publications, and/or patents that demonstrate significant scientific contributions to company technologies, processes, and/or products.
- Proficient with broad use computer applications such as MS Office and specialized statistical software applications as needed for job.
- Must be willing to work on multiple projects
- A strong team player with good collaborative and people skills
- Strong organization and prioritization skill, attention to details and ability for in-depth research and analysis
- Highly motivated with the ability to resolve technical issues, develop and implement corrective solutions, be able to quickly adapt and respond effectively to changes
- Experience with HPLC, calorimetry, spectrophotometry, light scattering, Freeze Drying Microscopy
- Experience working collaboratively with multi-disciplinary groups to achieve common goal
- Previous engagement in cross functional teams such as CMC and drafting of regulatory documents such as IND/BLA and or project management is a plus.
- Gene therapy experience is preferred
- Ability to efficiently plan and manage successful execution of multiple tasks
- PhD in Pharmaceutical Science, Biochemistry, Biophysical Chemistry, or related discipline with 0-2+ years of industry experience OR Equivalent combination of education and experience.
- The candidate is expected to interact with Formulation group members and collaborate with member of various departments including Analytical Development, Quality Control, Biophysical characterization, Purification, Cell Culture, Manufacturing, Clinical Sciences, Regulatory, Validation, QA and Contract Manufacturing and Project Management groups to jointly advance compounds through product development process.