Scientist I, Formulation DevelopmentLocation Novato, California Apply
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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.
SUMMARY OF JOB DESCRIPTION
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 analytical instruments to characterize biomolecules such as peptides, proteins and gene therapy products and the experience with formulation and drug delivery development and scale up processes. Candidate shall be familiar with laboratory work relevant to pharmaceutical and biopharmaceutical field. Candidate will be involved in drug product development and will interact with the Biophysical Characterization group, Analytical Development, Quality Control, Process Development, Manufacturing, Contract Manufacturing organization, Clinical Sciences, Project Management, Pharmacokinetics and Toxicology.
- Employ skills in the design and data analyses of experimental studies
- Able to integrate experimental design expertise with technical knowledge
- Execute 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 Teams to support PK, TK, drug safety and pharmacological studies in animal models
- Help define the foundation needed to formulate drug candidates into clinical and commercial dosage forms
- Conduct physicochemical and biophysical characterization of lead drug candidates
- 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.
- Expect to adhere to Good Scientific Practices, and SOPs
- Develop the technical skills of junior staff.
- Perform other related activities as assigned
- Ph.D., in the Pharmaceutical Sciences, Biochemistry, Biophysical Chemistry, Chemical Engineering 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.
- M.S. in the Pharmaceutical Sciences, Chemistry or Chemical Engineering with 5+ years (Scientist I) or 8+ years (Scientist II) of relevant experience in industry or research organization
- 0-2 years (Scientist I) or 2-5 years (Scientist II) of post- doctoral experience in a pharmaceutical R&D environment is preferred
- Experience in parenteral formulation development, including Lyophilization and/or Spray drying process development is preferred.
- Strong knowledge of protein formulation, protein chemistry, biophysical characterization, and analytical methods.
- Excellent analytical skills, oral and written communication skills, as well as a demonstrated ability to operate both independently and in team settings.
- Experience with analytical methods such as HPLC, DLS/SLS, DSC, ITC, UV, CD, FTIR, Raman is desired.
- Must be willing to work on multiple projects
- Experience in device and/or combination drug product development is preferred.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated.We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.