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Associate ScientistScientist Analytical Formulation Sciences

2 months ago

Gaithersburg, United States Salubris Biotherapeutics Inc Full time

Benefits:

401(k) matching

Bonus based on performance

Competitive salary

Dental insurance

Free food & snacks

Health insurance

Paid time off

Stock options plan

Vision insurance

Company Overview Salubris Biotherapeutics, Inc. (or SalubrisBio) is a science-driven biotechnology company dedicated to the discovery and global development of novel antibody therapeutics for the treatment of cancer, cardiovascular and metabolic diseases. We strive to develop novel therapeutic molecules that provide clinically meaningful improvements in disease burden and quality of life to patients with significant medical needs.

Role Summary SalubrisBio is seeking a highly motivated full-time scientist with exceptional experience in analytical and/or formulation development for biotherapeutic product development. The candidates shall have a strong ability in multi-tasking and is expected to work in a fast-paced and dynamic environment with a high degree of self-motivation.

Job Responsibilities · Act as a key expert in analytical and/or formulation development and/or product characterization for monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).

· Carry out tests including, but not limited to, HPLC (Protein A, SEC, RP, IEC, and HIC), CE-SDS, cIEF, DLS, SLS, MFI, glycan, peptide mapping, and intact mass LC-MS, etc.

· Compile scientific data, perform data analysis and interpretation, prepare technical reports, and present scientific data at project team meetings.

· Develop, qualify, and transfer analytical methods, prepare and review SOPs and assay development reports, and provide troubleshooting as needed.

· Identify, design, execute, and evaluate formulations for drug substance (DS) and drug product (DP) through thermo, conformational, and photostability and solubility studies.

· Collaborate and coordinate with colleagues in cell line, upstream, and downstream process development groups to support process development.

· Ensure adherence to GMP compliance as applicable.

· Support drafting and review of regulatory filings and technical documents.

Qualifications · BS, MS or Ph.D. in Biochemistry, Biophysics, Chemical Engineering, Biology, or other relevant scientific field with 3 - 5 years of biopharmaceutical industry or academic experience in the characterization or method development or formulation development for mAbs or ADC.

· Knowledge and hands-on experience in analytical methods: HPLC (SEC, RP, IEC, HIC, Protein A) and electrophoresis (CE-SDS and cIEF) is required. Experience in DLS, SLS, MFI, peptide mapping, intact mass LC-MS, disulfide bond mapping, and glycan profiling is preferred.

· Knowledge and hands-on experience in current approaches for clinical phase appropriate formulation development is preferred.

· Able to introduce and evaluate new technologies to improve the performance and efficiency of assays.

· Strong technical competency in analytical and/or formulation development and troubleshooting for instrument, assay, or testing failures.

· Good understanding of cGMP regulations relevant to biotherapeutic drug product development.

· Strong verbal and written communication skills and ability to manage multiple tasks simultaneously and pay attention to details.

· Ability to work independently in a small company setting with limited operational support.