Scientist 2 Analytical Sciences

DESCRIPTION

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

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.

SUMMARY

The Analytical Sciences team within the Technical Development & Services department at BioMarin Pharmaceutical Inc. is seeking a Scientist 2 to join the separations and biophysics team focused on method development, characterization of small molecules, oligo programs and/or gene therapy in support of CMC development. The successful candidate will be a self-motivated and critical thinker who has proven ability to work in a multi-disciplinary and fast-paced environment, and solid communication skills.

The candidate will be responsible for developing analytical methods using chromatography (HPLC, UPLC, GC), spectroscopy techniques (Raman, FTIR) and/or mass spectrometry, manage sample testing, compile sample testing results, and be able to summarize results. The selected candidate should possess excellent organizational, analytical and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.

An ideal candidate will have significant experience in (U)HPLC, GC, Spectroscopy based assays, analytical method development/qualification and excellent data handling practices. A good scientific understanding of protein chemistry and biochemistry is essential. Hands-on experience in recombinant biologics and peptide, small molecule therapies as well as prior knowledge of ICH and regulatory submissions is required.

RESPONSIBILITIES

• Execution of relevant experiments to support sample testing and development of analytical assays for clinical and commercial program in development.
• Develop separation methods such as size exclusion, ion exchange, reverse phase chromatography, capillary electrophoresis, and GC with mass spectroscopy, when applicable, for proteins, peptides, small molecule, gene therapy, conjugated molecules (PEGylated), and/or oligo programs, etc.
• Support analytical method development, qualification and transfer of spectroscopy-based techniques such as Raman, FTIR, IR and NMR.
• Manage CDMO interactions driving the development and implementation of methods supporting overall analytical control strategy.
• Troubleshoot and provide solutions for method improvements, when necessary
• Provide concise and quantitative analysis of data and interpretation of experimental results.
• Write up method protocols, qualification reports with in-depth summary of results and their interpretation. Catalogue data/reports electronically in an accessible manner for inspections.
• Present data proactively and regularly in group/functional meetings; communicate plans and results on regular basis to collaborators and functional leadership iteratively.

EXPERIENCE

Required Skills:

• Good understanding of protein/peptide, small molecule or oligo chemistry, structure, and function.
• Knowledge in standard liquid chromatography methods (e.g. SEC, IEX, RP-HPLC, and CE) and detectors: UV, FLD, CAD, ELSD and/or light scattering.
• Experience in mass spectrometry including LC-MS/MS, GC-MS, ICP-MS.
• Experience with spectroscopy-based techniques for raw material and product testing using Raman, FTIR, IR and NMR.
• Experience in phase appropriate analytical development supporting drug substance (DS), drug product (DP) assays and supporting formulation development across both early and late phases.
• Collaborative skills to work in a cross-functional environment
• Excellent writing skills including experimental documentation
• Proven data analysis, interpretation and communication, collaboration and scientific communication skills
• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment

Desired Skills:

• Knowledge of biopharmaceutical development of proteins, peptides, small molecule, gene therapy and/or oligo products.
• Hand-on experience in liquid chromatography, gas chromatography and mass spectrometry
• Knowledge of spectroscopy methods is a plus.

EDUCATION

PhD degree in analytical chemistry, biochemistryor related discipline and at least 2-4 years of relevant post graduate experience.

(OR)

Master's degree in analytical chemistry, biochemistry or related discipline and at least 6 years of relevant post graduate experience.

CONTACTS

Will report to Sr. Scientist 1, Analytical Sciences.

SUPERVISOR RESPONSIBILITY

May supervise, mentor, and/or manage research associates.