Analytical Scientist Gaithersburg

Analytical Scientist

Full Time • Gaithersburg
Benefits:
  • 401(k) matching
  • Bonus based on performance
  • Competitive salary
  • Dental insurance
  • Free food & snacks
  • Health insurance
  • Opportunity for advancement
  • Paid time off
  • Parental leave
  • Stock options plan
  • Tuition assistance
  • 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


We are seeking a highly motivated Analytical Scientist with a passion for advancing biopharmaceutical therapies to benefit patients. As a key member of our CMC team, you will contribute to method development, analytical testing, product characterization, formulation development, and regulatory submissions. Your support will ensure timely progress towards critical milestones, such as IND and BLA filing.


The ideal candidate thrives in a fast-paced, dynamic environment, demonstrates strong multitasking abilities, and takes initiative.


 


Responsibilities

·       Act as a subject matter expert in method development, product characterization, formulation development for monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
·       Perform analytical testing using techniques such as HPLC (Protein A, SEC, RP, IEC, and HIC), CE-SDS, glycan, peptide mapping, and intact mass LC-MS.
  • Design and execute formulation development studies with DLS, SLS, nanoDSF, and MFI to assess thermal, conformational, and solution stabilities as needed.
  • Collaborate with cell line, upstream, and downstream development teams to support process development. 
·       Lead or support method transfer, qualification, and testing at CDMOs.
·       Conduct compatibility studies of clinical administration components in partnership with analytical and clinical teams.
  • Draft and review SOPs, technical reports, and regulatory submission documents, addressing related technical inquiries.
·       Participate in lab management, including reagent and other consumables procurement and equipment maintenance and troubleshooting for equipment failure. 
·       Engage in scientific discussions, present findings, and ensure alignment with project timelines.

Qualifications

·       BS in Biochemistry, Chemistry, Chemical Engineering or related field with 0 - 5 years of biotech industry experience or PhD with 0–3 years of relevant experience. 

·       Hands-on expertise in analytical methods such as HPLC (SEC, RP, IEC, HIC, Protein A), CE-SDS, and cIEF for mAbs and/or ADCs.
·       Experience with formulation development, Design of Experiments (DOE), and statistical analysis for mAbs and/or ADCs is a plus.
·       Familiarity with DLS, SLS, nanoDSF, MFI, peptide mapping, intact mass LC-MS, and glycan profiling for mAbs and/or ADCs is preferred.
·       Ability to introduce and establish new technologies is advantageous.
·       Strong verbal and written communication skills, attention to detail, and multitasking abilities.
·       Self-motivated, eager to develop new skills, and comfortable working in a fast-moving, small-company environment.




(if you already have a resume on Indeed)

Or apply here.

* required fields

Location
Or
Or