Biologics Program Lead & SME — Scientific Liaison

Frontage Laboratories, Inc.; Exton, Northern (PA, KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Frontage Laboratories Inc. is seeking a Scientific Program Manager & Biologics SME to lead scientifically complex, GLP-compliant large molecule bioanalytical programs in Exton, PA. You will liaise with clients, design assays (PK/ADA/NAb, cell-based), and drive study delivery with QA, PM, BD, and operations.

The role requires 5+ years of relevant assay experience, CRO background, and strong communication skills to support proposals, study reports, and sponsor interactions.

Qualifications

• Master’s degree or higher in Biology, Biochemistry, Pharmaceutical Sciences, Immunology, or related field (PhD preferred but not required).
• 5+ years of hands-on experience developing, validating, and troubleshooting large molecule assays, including PK, ADA, NAb. Cell-based NAb assays.
• Demonstrated knowledge of GLP regulations (21 CFR Part 58) and experience supporting non-GLP and clinical programs.
• Strong ability to interpret complex scientific data and communicate clearly with internal teams and external sponsors.
• Experience working in a CRO or regulated bioanalytical environment strongly preferred.

Responsibilities

• Present and introduce Biologics services to clients, including LBA-based assays for PK, ADA, NAb, and cell-based functional assays.
• Provide scientific consultation during pre-clinical and clinical program design, including assay selection, format, feasibility, and method development strategy.
• Serve as subject matter expert on large molecule assay performance, MRD, analytical range, cut-point strategy, validation parameters, and sample analysis workflow.
• Act as scientific point-of-contact for assigned programs; attend kickoff, alignment, troubleshooting, and result review meetings.
• Coordinate with Program Management to ensure timelines, deliverables, and sponsor expectations are clearly communicated and met.
• Prepare or review scientific sections of proposals, protocols, validation plans, and study reports.
• Collaborate with lab supervisors and technical teams to troubleshoot assay challenges and implement scientific improvements.
• Familiar with regulatory frameworks including FDA 21 CFR Part 58 (GLP); Non-GLP discovery and early development programs.

Skills

Scientific communication

Client engagement

Project management

Regulatory understanding

Education

Master’s degree or higher in Biology/Pharmaceutical Sciences/Immunology

PhD preferred but not required

Tools

Bioanalytical platforms

Job description

Frontage Laboratories Inc. is seeking a Scientific Program Manager & Biologics SME to lead scientifically complex, GLP-compliant large molecule bioanalytical programs in Exton, PA. You will liaise with clients, design assays (PK/ADA/NAb, cell-based), and drive study delivery with QA, PM, BD, and operations.

The role requires 5+ years of relevant assay experience, CRO background, and strong communication skills to support proposals, study reports, and sponsor interactions.