The Formulation & Process Development group located at the Foster City, CA Gilead headquarters is seeking a Research Scientist II to provide scientific, technical and hands-
on support of drug discovery and product development.
The qualified candidate will be responsible for drug product development from lead optimization to clinical development and through commercialization, and should have experience and / or knowledge in preformulation, formulation development, and process selection and scale up based on Quality by Design (QbD), oversight of GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs, MAAs).
The qualified candidate will be responsible for lead optimization, API form selection / characterization, preformulation, formulation development, manufacture of clinical supplies, development of efficient and scalable manufacturing processes, process scale up based on Quality by Design (QbD), implementation of innovative technologies, CMO management and global regulatory strategy.
Required Skills :
Experienced in formulation and process development and scale-up of parenteral drug products.
Expertise in parenteral drug delivery technologies. Knowledge of sustained release parenteral delivery is preferred
Knowledge of basic analytical skills required : HPLC, UV, solid state characterization.
Excellent communication skills (both verbal and technical) and interpersonal skills are required.
Essential Duties and Job Functions :
Responsible for developing chemical processes for the manufacturing of drug substances.
Familiar with Pilot Plant operations and able to write master batch records and safety summaries with limited supervision.
Pays particular attention to avoiding reactions and processes that do not scale well, such as distilling to dryness and flash chromatography.
May suggest alternative chemistry including step optimization and new route selection.
Gains a better understanding of how impurities are formed, tracked and purged throughout the subsequent processing.
Works in collaboration with more senior scientists or scientific directors to advance the development of economical, state-
of-the-art techniques to isolate, characterize, purify and mass-produce substances.
Works on complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.
Advises members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
Makes contributions to scientific literature and conferences through publication and presentation of research results.
Maintains full working knowledge of state-of-the art principles and theories, applying such knowledge to the direction that supports Company interests.
Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and strategy.
Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
Demonstrates excellent verbal communication skills and interpersonal skills.
Demonstrates collaborative communication and problem solving spirit.
Knowledge, Experience, and Skills Required :
PhD in a related scientific discipline 3+ years’ industry experience.
BS or MS degree with extensive industry experience.
Ideal candidate will have degree in pharmaceutical sciences, chemical engineering, physical organic chemistry.
Academic Level - PhD