Scientist I/II, Formulation Development
- Employer
- BioMarin Pharmaceutical Inc.
- Location
- Novato, California
- Start date
- Jun 15, 2021
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- Discipline
- Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay, Best Places to Work
Job Details
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.
JOB RESPONSIBILITIES
- 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
EDUCATION
- 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
EXPERIENCE
- 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. HPLC, enzyme assays, ELISA, instrumental analytics)
- 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 parenteral formulation development, including Lyophilization and/or Spray drying process development is preferred.
- Experience in device and/or combination drug product development is preferred
Company
BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.
Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.
Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.
- Website
- https://www.biomarin.com/
- Location
-
California
United States
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