Job Description Sr. Research Scientist II, Formulation & Process Development
United States - California - Foster City
Process/Product Development & Operations
Regular
Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations. Join Gilead and help create possible, together.
Sr. Research Scientist II, Formulation & Process Development
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
The Formulation & Process Development group located at the Foster City, CA Gilead headquarters is seeking a Senior Research Scientist II to provide scientific, technical and hands-on support of drug discovery and product development related to small molecules.
The Senior Research Scientist II will be responsible for lead optimization, API form selection/characterization, pre-formulation, 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.
Knowledge, Experience and Skills:
- Experienced in formulation and process development, manufacture, and scale-up of solid oral dosage and/or parenteral drug products.
- Expertise in solid oral dosage and/or parenteral drug delivery technologies, including sustained release.
- Knowledge of basic analytical skills required: HPLC/UPLC, UV, solid state characterization.
- Excellent communication skills (both verbal and written) and interpersonal skills are required.
- Works independently to design, execute and analyze laboratory experimentation.
- Works on complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.
- Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
- 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.
- Experience and/or knowledge in pre-formulation, formulation and process development, Quality by Design (QbD), oversight of GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs, MAAs).
Minimum Qualifications:
- PhD in a related scientific discipline with 5+ years’ industry experience in a related scientific field.