Scientist I, Purification Process Development and Biophysical Characterization
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.
The candidate will be a highly motivated individual ready to work in Process Sciences as part of a collaborative, multidisciplinary drug product development environment. The position will focus on purification and biophysical characterization activities of gene therapy and protein-based therapeutics, emphasizing biochemical and biophysical characterization of these molecules and their degradation products. Including understanding structure function relationships, solubility profiles, thermodynamics/kinetics and interactions with other molecules.
The Scientist I position will be part of the Biophysical Characterization group within Process Sciences. The scope of the work includes biophysical characterization and drug product development in support of early candidate and process selection. The individual will be responsible for developing and implementing novel biophysical and biochemical methodologies for characterization of different gene therapy and protein biologics molecules in pre-clinical and clinical phase. The ideal candidate will have in-depth knowledge and hands-on experience working with AAV viral capsid and protein biologic purification and characterization using a myriad of analytical tools for spectroscopic, calorimetric, and physicochemical solution analysis. The candidate should be an effective communicator of ideas, project goals and results to team members in collaborating departments. The ability to proactively identify issues and develop solutions in a collaborative multidisciplinary environment is essential.
Responsibilities include but are not limited to the following:
- Manage the development, optimization and implementation of biophysical characterization activities within Process Sciences for various gene therapy and protein biologic programs
- Design and implement studies independently, including but not limited to solubility profile, structure function relationship, protein-excipient compatibility and protein-analyte binding kinetics and affinities
- Analyze stability and solution properties of bio therapeutics using AUC, SEC/FFFMALS, DSF, DSC, ITC, CD and related technologies
- Support purification development activities of AAV capsid program from time to time as required.
- Be a hands-on presence in the laboratory
- Prepare and write technical reports, summarizing the results of studies.
- Participate in multi-departmental projects and discussions, communicating data, results and recommended next steps to project and group leaders clearly and effectively
- Interact with various functional groups within Process Development, Formulation Development, Analytical Development, QC, and Manufacturing
- Work on multiple projects simultaneously while meeting aggressive timelines
- Develop outside collaborations (academic, vendor, and other) to further progress technical capabilities of the department
A Ph.D. degree in Biochemistry, Biophysics, Analytical Chemistry or a related field. A strong background in viral vector gene therapy, protein chemistry or related fields is preferred.
Experience should include 0 – 2 years of relevant academic or industry experience in the development of viral vector or protein based therapeutics.
- Hands-on experience in the biotechnology industry or academic setting with a broad range of techniques focused on protein/AAV capsid purification and characterization is required
- Proficiency in understanding structure function relationship of viral vectors used in gene therapy is highly desired
- Good understanding of AAV capsid based gene therapy is highly desired
- Experience with various biophysical characterization methods is a plus:
- Analytical Ultracentrifugation (AUC)
- Spectroscopic methods (UV, CD, NMR, fluorescence, FTIR and Raman)
- Thermodynamic methods (DSC and ITC)
- Light scattering methods, (MALS, DLS and SLS)
- Subvisible particulate characterization methods, (MFI and HIAC)
- Other (confocal microscopy, qPCR, ddPCR, Octet and SPR)
- Experience with mass spectrometric techniques (LC-MS, MALDI-MS) is a plus
- Strong analytical troubleshooting skills are required
- Current knowledge on regulatory guidelines related to biologic pharmaceutical development, characterization, and comparability is a plus.
- Excellent project management, verbal/written communication, and interpersonal skills are required
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.