Sr. Research Associate I, Tech Ops
Biomarin Pharmaceutical - Novato, CA
posted 16 days ago
About the position
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. The selected candidate will work in the Separations and Biophysical Assays team within the Analytical Sciences group to assist in the advancement of BioMarin's therapeutics for clinical evaluation and potential commercialization. The candidate will be responsible for development and qualification of new biophysical/ biochemical assays, provide routine testing and characterization support to partner groups to help with early candidate selection, process development, and drug substance and drug product process characterization.
Responsibilities
- Support the Separations and Biophysics group within Analytical Sciences.
- Be a hands-on presence in the laboratory, supporting biophysical/ biochemical assay development and qualification using HPLC, MALS, DLS, AUC, DSF CD, DSC, etc for various modalities.
- Provide routine analytical characterization & testing support to partner groups including Upstream and Downstream PD, Formulations, and Research & Early Development (RED).
- Document experimental results in the company electronic lab notebook (Benchling), author procedures, and contribute to technical documentation (test methods, development reports).
- Actively participate in the operational aspects of the laboratory by conducting safety inspections, lab organization, ordering supplies, and performing routine equipment maintenance.
- Present scientific literature and results from ongoing studies at group meetings and other discussion forums at the company.
- Other duties as assigned.
Requirements
- Hands-on experience in the biotechnology industry or academic setting with a broad range of analytical techniques focused on protein, peptide, protein-conjugates, RNA-based and/or virus-based analytical testing and characterization.
- Experience with biophysical and biochemical characterization methods.
- Experience with light scattering methods (MALS, DLS).
- Experience with Analytical Ultracentrifugation (AUC).
- Experience with chromatographic purification methods (HPLC, UPLC, CE).
- Experience with spectroscopic methods (UV, CD, fluorescence, FRET, FRAP).
- Experience with thermodynamic methods (DSC and ITC).
- Experience with label-free binding methods (BLI/Octet, SPR).
- In-depth technical understanding of all aspects of analytical testing, phase appropriate regulatory requirements, method qualifications and method transfers.
- Ability to independently troubleshoot issues, ideate and develop insights to technical challenges and propose solutions to solve them.
- Demonstrates attention-to-detail and 'right-the-first time' approach.
- Excellent written and oral communication skills, with the ability to communicate complex information.
- Ability to influence others effectively and develop collaborative relationships with partner teams.
- Familiar with use of statistical software, electronic document management, and laboratory information management.
- Ability to effectively analyze complex problems and present results effectively within and beyond the department.
- Ability to flexibly adapt to changing business needs and meet timelines.
- Strong organizational skills with the ability to effectively multi-task and prioritize.
Nice-to-haves
- Experience in method development, qualification, and transfer to/from other laboratories such as development, quality control.
- Knowledge of biopharmaceutical process development.
- Experience with automation.
- Experience working in a cross-functional environment.
- Good understanding of root cause analysis methodology.
Benefits
- Discretionary bonus and/or long-term incentive units may be provided as part of the compensation package.
- Full range of medical, financial, and/or other benefits.
