Scientist 2, Separations and Biophysical Characterization

Location:  Novato, California Category: Technical Development

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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.

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

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 group, part of the Technical Development & Services department at BioMarin Pharmaceutical Inc., is seeking a Scientist 2 for the Separations and Biophysics Assays team. This position will focus on biophysical method development and the characterization of protein-based therapeutics - enzymes, conjugated proteins, peptides, emphasizing biochemical and biophysical characterization of these molecules and their degradation products to support CMC product development across early, late-stage, and commercial assets. This includes structure function relationship, solubility profiles, thermodynamics/kinetics and interactions. The ideal candidate will demonstrate strong motivation, critical thinking abilities, effective communication skills, and experience working successfully in multidisciplinary, fast-paced environments. 
 
The candidate will be responsible for developing methods utilizing a range of biophysical techniques, including AUC, CD, DSC, DSF, DLS, ITC, SEC-FFF/MALS and other relevant technologies. Responsibilities also include managing sample testing, compiling test results, and effectively summarizing findings. The individual should demonstrate exceptional organizational, analytical, and communication abilities, and exhibit initiative and efficiency while collaborating in a dynamic, team-oriented environment. 
 
The ideal candidate will have extensive experience and strong expertise in characterizing proteins, peptides, and other modalities using diverse biophysical and analytical methods. Effective communication with cross-functional teams, proactive problem-solving, and collaboration in multidisciplinary settings are essential. Solid knowledge of protein chemistry and biochemistry is required, along with hands-on experience in CMC development of recombinant biologics, peptide and small molecule therapies, and familiarity with ICH guidelines and regulatory submissions. 
 
 
RESPONSIBILITIES
 
  • Manage the development, optimization and implementation of biophysical characterization activities within Analytical Sciences for various protein-based therapeutics and other modalities.
  • Design and conduct studies independently, including but not limited to assess protein structure, structure function relationship, protein-excipient compatibility, solubility, and binding kinetics and affinities.
  • Use biophysical methods (AUC, CD, DSC, DSF, DLS, ITC, SEC-FFF/MALS) to analyze stability and solution properties for various therapeutics.
  • Develop and qualify biophysical methods for products from early (pre-clinical) to commercial stages.
  • Manage CDMO partnerships to implement analytical methods or troubleshoot if necessary.
  • Troubleshoot and optimize methods.
  • Provide quantitative analysis and interpretations; prepare protocols, reports, and maintain electronic records for inspections.
  • Present data regularly to teams and leadership.
  • Write technical reports summarizing study outcomes.
  • Handle multiple projects and tight deadlines.
  • Develop external collaborations to advance departmental capabilities.
 
Required Skills:
  • In-depth understanding of biophysical methods for protein structure and function, protein chemistry, small molecule or oligo chemistry structure, and function. 
  • Subject matter expertise in biophysical methods using AUC, CD, DSC, DSF, DLS, ITC, SEC-FFF/MALS, and other areas such as subvisible particulate characterization, microscopy.
  • Knowledge in standard liquid chromatography methods (e.g. SEC, IEX, RP-HPLC), capillary electrophoresis (CE, cIEF) and detectors: UV, FLD, CAD, and ELSD.
  • 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:
  • CMC knowledge of pharmaceutical development of proteins, peptides, small molecule, gene therapy and/or oligo products and higher order structure characterization and interpretation of data.
  • Experience in development of methods, designing of experiments using AUC, CD, DSC, DSF, DLS, ITC, SEC-FFF/MALS, and other related technologies
  • Experience in liquid chromatography using SEC, RPLC and capillary electrophoresis (CE, cIEF).
  • Excellent project management, verbal/written communication, and interpersonal skills.
  • Prior management experience with ability to lead, mentor and manage direct reports on a daily basis.
 
EDUCATION
PhD degree in Biophysics, Biochemistry, Chemistry or related discipline and minimum 5 years of relevant post graduate experience in the industry. 
(OR)
Master’s degree in biochemistry or chemistry or related discipline and minimum 7 years of relevant post graduate experience in the industry. 
 
CONTACTS 
Will report to Sr. Director, Analytical Sciences. 


Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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