Analytical Scientist (Biologics)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical technologies and regenerative biologics intended to improve surgical outcomes and the quality of life of patients with musculoskeletal disorders.

What you will do

• Develop, optimize, and validate analytical methods for recombinant protein characterization, including purity, identity, potency, and structural integrity.
• Perform and troubleshoot HPLC/UPLC, capillary electrophoresis, LC-MS, UV-Vis, circular dichroism, and FTIR analyses.
• Support formulation development, process development, and stability studies by analyzing protein structure and degradation pathways.
• Coordinate assay development, transfer, and validation activities with external CDMOs and CROs.
• Collaborate with process development, formulation, and quality teams on CMC development.
• Interpret complex analytical data and prepare technical reports, SOPs, protocols, regulatory submissions, and scientific publications.

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, Biotechnology, or a related field, or an M.S. with 5+ years of protein analytical development experience.
• Strong expertise in chromatographic, electrophoretic, and mass spectrometry-based methods for protein characterization.
• Hands-on experience with method development, qualification, and validation in GMP/GLP environments.
• In-depth knowledge of protein chemistry, post-translational modifications, aggregation, and degradation mechanisms.
• Familiarity with ICH, FDA, and EMA guidelines and CMC requirements for biologics.
• Proficiency with analytical data software such as Empower, MassLynx, Genedata, Origin, or JMP, plus strong technical writing and collaboration skills.

Culture & Benefits

• Full-time employment within a growing Regenerative Biologics group.
• Culture built around innovation, customer focus, teamwork, and results-driven execution.
• Commitment to ethical business practices, regulatory compliance, inclusion, and respectful collaboration.
• Reasonable accommodations are available for individuals with disabilities.