Purification Process Development Scientist

Job Description

Benefits:

401(k) matching

Bonus based on performance

Competitive salary

Dental insurance

Health insurance

Opportunity for advancement

Paid time off

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.

Position Summary:

We are seeking a motivated and technically skilled Purification Process Development Scientist with hands-on experience purifying monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), and antibody-drug conjugates (ADCs). This role is ideal for someone with a bachelors degree and approximately 4-7 years of industry experience, who has contributed to technology transfer of antibody-based therapeutics to GMP manufacturing sites. The successful candidate will support process development, scale-up, and technology transfer activities in early- to late-stage development.

Responsibilities:

Develop, optimize, and characterize downstream purification processes for mAbs, bsAbs, and ADCs, including Protein A, ion exchange chromatography, and UF/DF steps.

Support the development of processes for complex antibody formats and conjugation-related purification challenges.

Support and execute technology transfer to internal manufacturing teams or external CDMOs, including preparation of process descriptions, protocols, and batch records.

Assist in the design and execution of experiments for process characterization, scale-up, and comparability studies to support clinical and commercial production.

Collaborate with cross-functional teams including upstream PD, analytical development, formulation, quality, and regulatory to align on CMC strategy.

Generate and maintain technical documentation including study plans, tech transfer documents, and regulatory filing support materials.

Participate in investigations, risk assessments, and implementation of process improvements and changes.

Control and selection of raw materials and implementation into ManufacturingQualifications:

B.S. in Biochemistry, Chemical Engineering, Biotechnology, or related discipline.

4-7 years of relevant industry experience in downstream process development for antibody therapeutics (mAbs, bsAbs, or ADCs).

Hands-on experience with purification challenges unique to bsAbs or ADCs (e.g., removal of linkers, aggregates, drug species).

Demonstrated experience supporting or executing tech transfer to CDMOs or internal GMP manufacturing.

Familiarity with downstream unit operations including affinity chromatography (e.g., Protein A), ion exchange, HIC, size-exclusion, and filtration.

Strong data analysis and documentation skills.

Comfortable working in a fast-paced, collaborative team environment.

Exposure to process characterization and QbD principles preferred

Experience with statistical tools (e.g., JMP) is a plus.Travel: Up to 5%, primarily for site visits, technology transfer, and manufacturing support.

Full-time