Scientist, Protein Formulation

Job Description
The selected candidate will characterize the physicochemical properties of protein drug candidate compounds, develop non-clinical formulations for efficacy and toxicology studies, perform preformulation 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 protein molecules. He/she will interface with the Discovery Sciences, Analytical Development, Quality Control, Process Development, Pharmacokinetics, Metabolism and Toxicology to collaboratively move compounds from Discovery into 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.


RESPONSIBILITIES

• 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 molecules

• 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 protein drug candidates into clinical and commercial dosage forms

• Perform preformulation stability and solubility studies

• Conduct physicochemical and biophysical characterization of lead drug candidates

• Develop liquid and lyophilized protein 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 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.

EDUCATION

• Ph.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 2 position.

• M.S. in the Pharmaceutical Sciences, Chemistry or Chemical Engineering with 5+ years (Scientist I) or 8+ years (Scientist II)

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)

• Must be able to solve complex physicochemical issues in drug development

• 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

Company

BioMarin Pharmaceutical Inc.

Job Code

State or Province

California

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