Formulation Scientist

Company Overview

Salubris Biotherapeutics, Inc. (“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 Scientist Formulation (Scientist III) with a strong passion for advancing biopharmaceutical therapies to benefit patients. As a key member of our CMC team, you will collaborate on a wide range of activities, including formulation development, analytical testing, drug product manufacturing at CDMOs, pre-clinical and clinical study support, and regulatory submissions. You will play a key role in formulation development, product manufacturing, and analytical testing, ensuring the timely progress toward critical milestones.

The ideal candidate thrives in a fast-paced, dynamic environment, with strong multitasking abilities, self-motivation, and initiative

Responsibilities

• Lead formulation development and drug product (DP) manufacturing activities, including Fill/Finish processes at CDMOs, for novel biotherapeutics.
• Act as a subject matter expert (SME) in developing stable, robust formulations for clinical-stage biotherapeutics, including bispecific antibodies and antibody-drug conjugates (ADCs).
• Design, execute, and evaluate formulations through various stability studies (e.g., thermal, conformational, solubility, and photostability).
• Perform analytical testing (SEC, DLS/SLS, Osmolality, MFI/HIAC, etc) to assess aggregation, fragmentation, particle formation, product stability (thermostability, conformational stability, and photostability).
• Oversee the selection of DP containers and packaging material, coordinate DP Fill/Finish processes with CDMOs, and manage bulk shipment and labelling as needed for clinical supplies.
• Ensure GMP compliance during DP Fill/Finish at CDMOs, including person-in-plant (PiP), review of batch records, SOPs, and technical reports.
• Lead compatibility studies of clinical administration components, collaborating closely with analytical and clinical teams.
• Collaborate effectively with internal teams (e.g., downstream purification, analytical, and clinical) and external partners.
• Contribute to regulatory filings by preparing and reviewing technical reports and addressing any related technical inquiries.
• Participate in day-to-day lab management, including ordering reagents and maintaining equipment.
• Engage in scientific discussions, prepare technical reports, present findings, and ensure adherence to project timelines.

Qualifications

• MS/PhD in Biochemistry, Biophysics, Chemical Engineering, or related field with a minimum of 5 years of biotech industry experience in formulation development and GMP DP Fill/Finish manufacturing at CDMOs.
• Hands-on expertise in formulation development methodologies, including Design of Experiments (DOE) and statistical approaches.
• Strong technical skills in analytical techniques, such as DLS, SLS, Nano DSF, MFI, HIAC, FT-IR, and CD, including troubleshooting for testing failure or instrument failure.
• Solid understanding of cGMP regulation related to biotherapeutic drug product development and DP Fill/Finish manufacturing.
• Excellent communication in verbal and writing and multitasking abilities, with keen attention to detail.
• Self-motivated and eager to develop skills while contributing to team goals in a small, dynamic company environment.