Scientist I/II, Protein FormulationLocation Novato, California Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The selected candidate will perform formulation development screening studies and develop clinical/commercial formulations and fill/finish processes for drug products. He/she will also define appropriate primary packaging and delivery devices for the finished drug product as needed. To accomplish these functions, the selected candidate should preferably possess the skills to utilize a diverse array of analytical instruments to characterize peptide and protein molecules and the experience with lyophilization development and scale up process, drug- device combination product development. He/she will interface with the Biophysical Characterization group, Analytical Development, Quality Control, Process Development, Manufacturing, Contract Manufacturing organization, Clinical Sciences, Project Management, Pharmacokinetics and Toxicology to collaboratively move compounds through product development.
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 new innovation.
- Employ advanced skills in the design and data analyses of experimental studies
- Able to integrate experimental design expertise with technical knowledge
- Expeditiously executes experimental work to meet project goals and timelines
- Utilize a diverse array of analytical instruments to characterize protein or gene therapy products
- Provide formulation support to Discovery to support PK, TK, drug safety and pharmacological studies in animal models
- Help define the level of difficulty needed to formulate drug candidates into clinical and commercial dosage forms
- Conduct physicochemical and biophysical characterization of lead drug candidates
- Develop liquid and lyophilized formulations and drug delivery systems
- Disseminate research and development work in writing or oral presentation as needed
- Maintain good documentation and assist in the preparation of presentations, patents, IND, BLA and NDA documentation.
- Perform other related activities as assigned
- Expect to adhere to Good Scientific Practices, and SOPs
- Develop the technical skills of junior staff.
- D., in the Pharmaceutical Sciences, Biochemistry, Biophysical Chemistry or related discipline
- 0-2 years of post- doctoral experience in a pharmaceutical R&D environment or in a University for Scientist I position or 2 – 5 years for Scientist II position.
- S. in the Pharmaceutical Sciences, Chemistry or Chemical Engineering with 5+ years (Scientist I) or 8+ years (Scientist II)
- 0-2 years (Scientist I) or 2-5 years (Scientist II) of post- doctoral experience in a pharmaceutical R&D environment is preferred
- Strong knowledge of protein formulation, protein chemistry, biophysical characterization and analytical methods development.
- Experience with performing analytical procedures (e.g. Chromatographic assays, Spectroscopic Techniques, Thermal Analysis, Karl-Fischer Titration)
- Excellent analytical skills, oral and written communication skills, as well as a demonstrated ability to operate both independently and in team settings.
- Must be willing to work on multiple projects.
- Experience in device and/or combination drug product development is preferred.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.