Scientist I/II, Biophysical CharacterizationLocation Novato, California Apply
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 biophysical characterization activities of protein and gene therapy (Primarily AAV) based therapeutics, emphasizing biochemical and biophysical characterization of these molecules and their degradation products. Approaches include understanding structure function relationships, solubility profiles, thermodynamics/kinetics and interactions with other molecules.
The Scientist I/II 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 molecules in pre-clinical and clinical phase. The ideal candidate will have in-depth knowledge and hands-on experience in biologic formulation 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 the following:
- Manage the development, optimization and implementation of biophysical characterization activities within Process Sciences
- 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 SEC/FFFMALS, DSF, DSC, ITC, CD and related technologies
- 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 in 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 (AAV) 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 protein or viral vector (AAV) based therapeutics.
- Hands-on experience in the biotechnology industry or academic setting with a broad range of techniques focused on protein characterization is required
- Proficiency in understanding structure function relationship of viral vectors used in gene therapy is highly desired
- Proficiency in protein degradation pathways and general protein thermodynamics/kinetics is desired
- Experience with various biophysical characterization methods is a plus:
- 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 (AUC, confocal microscopy, qPCR, ddPCR, Octet and SPR)
- Experience with multiple HPLC methodologies, hardware and software platforms is desired
- 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
WORK ENVIRONMENT / PHYSICAL DEMANDS
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Other scientists within Purification Process Development, Cell Culture Process Development, Analytical Chemistry, Quality Control, and Formulation; project managers, and laboratory associates.
May include one or more research associates