Benefits:

401(k) matching

Bonus based on performance

Competitive salary

Dental insurance

Free food & snacks

Health insurance

Paid time off

Parental leave

Stock options plan

Training & development

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 Scientist III/Principal Scientist - Drug Product Development 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 biologics formulation development in house and drug product process development, optimization and characterization, and validation (PPQ), and drug product manufacturing at CDMOs, pre-clinical and clinical study support, and regulatory submissions. You will play a key role in formulation and DP process development, and drug product manufacturing, ensuring the timely progress toward critical milestones from early development to commercialization of the pipeline programs. The ideal candidate thrives in a fast-paced, dynamic environment, with strong multitasking abilities, self-motivation, and initiative

Responsibilities

Lead biologics formulation, drug product (DP) process development and manufacturing at CDMOs, including Fill/Finish processes, for novel biotherapeutics during different clinical stages.

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).

Lead drug product process development, optimization, and characterization from early to late-stage stages of clinical development.

Serve as the liaison to the DP CDMOs and track progress on different activities in collaboration with the CDMOs.

Lead drug product process validation activities, including process validation master plan, process performance qualification (PPQ) readiness, and execution.

Perform analytical testing (SEC, DLS/SLS, Osmolality, MFI, etc) for formulation development in-house as needed.

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. Travel requirements for the role is 10-20%.

Support DP CDMO and third-party logistics selection and oversight activities required for the development and manufacturing of the pipeline programs.

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 8 years of biotech industry experience in early to late-stage formulation, DP process development, and GMP DP Fill/Finish manufacturing at CDMOs.

Hands-on expertise in formulation and DP process development methodologies, including Design of Experiments (DOE) and statistical approaches.

Experience in leading late-stage activities, including process characterization and PPQ preparation activities, working with CDMOs is highly preferred.

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, are advantageous.

Solid understanding of cGMP regulation related to biotherapeutic drug product development and DP Fill/Finish manufacturing.

Experience authoring IND, IMPD, and/or BLA/MAA sections is preferred.

Excellent communication skills in verbal and written, and multitasking abilities, with keen attention to detail.

Self-driven and eager to collaborate while contributing to team goals in a small, dynamic company environment.