Job Details
Position Summary
We seek a creative and curious individual to join our analytical development team as a Bioanalytical Scientist II-III or Sr. Scientist to support analytical method development and molecule developability assessments enabling IGM Biosciences IND portfolio. The individual will contribute to the fundamental understanding of the function-structure relationship for engineered IgM molecules. The candidate must be well versed in biophysics/biochemistry, organized, capable of multi-tasking, and strongly desire to work in a fast-paced, team-oriented, dynamic environment.
Responsibilities:
- Lead the candidate assessment (developability assessment)for biologics at early and late preclinical stages of drug discovery.
- Scope of developability assays with responsibility for method development, optimization, and execution: AC-SINS, BVP-ELISA, SEC-, HIC-, IEX-, reverse phase HPLC, HILIC, SEC-MALS, BLI or SPR, DLS, DSF, CE-SDS, cIEF, HILIC, LC-MS, and peptide mapping)
- Lead the characterization of molecules in the IGM pipeline, including product and process-related impurities, to generate the data package for IND applications.
- Contribute to method transfer (non-GMP and GMP) to internal Quality Control and external (CRO / CDMO / CMO) organizations, including tracking and managing progress and coordinating sample shipping.
- Research literature to identify novel methodologies, solve scientific problems, and apply them to the program.
- Evaluate new analytical techniques and explore their application to IgM antibody characterization.
- Maintain an organized, analytical lab environment, complying with Federal and California safety regulations.
- Maintain laboratory equipment inclusive of mass spectrometer U/HPLC, UNCLE, SoloVPE, plate readers and washers.
- Generate data for and author method development protocols, reports, SOPs, and relevant sections in regulatory filings.
- Publish research in peer-reviewed journals and present work at scientific conferences when possible.
- Keep accurate and current records of research and project-related activities and share data with management and team members.
- Other duties may be assigned.
Qualifications:
- Level commensurate with experience and education.
- Chemistry, Biochemistry, Biology, or related background, BS with 11+ years, MS with 6+ (Associate Scientist), or Ph.D. (Scientist I) with 0 - 2 years of hands-on Bioanalytical Lab experience, preferably in the biotech/biopharmaceutical setting.
- Experience with mass spectrometry inclusive of software(LC-MS, peptide mapping), HPLC (SEC-, IEX-, RP-, EC-, HIC-), SEC-MALS, DLS, DSC, UNCLE, UV-Vis spectroscopy, and biologics sample handling is a must.
- Experience with other physicochemical techniques, including capillary electrophoresis (CE-SDS, cIEF), particle analysis by MFI, viscosity, and osmolality, is a plus.
- Experience in biologics developability assessment is strongly preferred.
- Experience in formulation development is a plus.
- Willing to learn new techniques and become a subject matter expert.
- Self-starter with the ability to work independently or with limited direct supervision on multiple projects simultaneously and effectively function in a team environment.
- Excellent organization, interpersonal, and communication skills (both written and verbal) and ability to clearly and effectively present data at group and company meetings.
- Physical ability to lift up to 40 lbs and work at the lab bench for extended periods.
- Must be able to commute to Mountain View.